Acute Ischaemic StrokePhase 3THALESNCT03354429

THALES - Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death

A Phase 3 study testing Ticagrelor in people with Acute Ischaemic Stroke and Transient Ischaemic Attack, run by AstraZeneca at 387 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo (inactive tablet) and ASA in preventing new stroke events Read more about this study

Who is it for?: Ages 40 to 130 years
Conditions the study is for: Acute Ischaemic Stroke, Transient Ischaemic Attack
What is being tested?: Ticagrelor
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11,016 participants
Where: 387 sitesin 28 countries
Study dates: 22 Jan 2018to 13 Dec 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of signed informed consent prior to any study-specific procedure
≥40 years of age
Acute onset of cerebral ischaemia due to
AIS with NIHSS ≤5. AIS is defined as acute onset of neurological deficit attributed to focal brain ischaemia, and either of the following:
Persistent signs or symptoms of the ischaemic event at the time o randomisation, OR
Acute ischaemic brain lesion documented before randomisation by computed tomography (CT) scan or magnetic resonance imaging (MRI) (diffusion-weighted imaging) and that could account for the clinical presentation

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High-risk TIA, defined as neurological deficit of acute onset attributed to focal ischaemia of the brain by history or examination with complete resolution of the deficit, and at least one of the following:
ABCD2 score ≥6 and TIA symptoms not limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo
Symptomatic intracranial arterial occlusive disease that could account for the clinical presentation, documented by transcranial Doppler or vascular imaging and defined as at least 50% narrowing in the diameter of the vessel lumen
Internal carotid arterial occlusive disease that could account for the clinical presentation, documented by Doppler, ultrasound, or vascular imaging and defined as at least 50% narrowing in diameter of the vessel lumen
Randomisation occurring within 24 hours after onset of symptoms; for wake-up strokes (when the time of symptom onset is not known), within 24 hours from the time point at which the patient was reported to be in their normal condition
CT or MRI performed after symptom onset ruling out intracranial haemorrhage or other pathology, such as vascular malformation, tumour, or abscess that according
to the Investigator could explain symptoms or contraindicate study treatment

Who cannot join

Need for or an anticipated need for any of the following:
Dual antiplatelet therapy with ASA and P2Y12 inhibitors (including patients with carotid artery stenting and percutaneous coronary intervention)
Antiplatelets other than ASA (eg, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol, ticagrelor) and other antithrombotic agents with antiplatelet effects, including traditional/herbal medicine agents
Anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, fondaparinux, or unfractionated heparin and long-term treatment with low-molecular weight heparins). Short-term treatment (≤7 days) with low-dose low-molecular weight heparin may be used in immobilised patients at the discretion of the Investigator
Any history of atrial fibrillation/flutter, ventricular aneurysm, or suspicion of other cardioembolic pathology for TIA or stroke
Patients who should receive or have received any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation

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Planned carotid endarterectomy that requires halting investigational product within 3 days of randomisation or is expected to require unblinding of investigational product (planned carotid endarterectomy is in itself not an exclusion criterion)
History of previous intracranial haemorrhage at any time (asymptomatic microbleeds do not qualify), gastrointestinal haemorrhage within the past 6 months, or major surgery within 30 days
Patients considered to be at risk of bradycardic events (eg, known sick sinus syndrome or second- or third-degree atrioventricular block) unless already treated with a permanent pacemaker
Inability of the patient to understand and/or comply with study procedures and/or follow-up, in the opinion of the Investigator
Known hypersensitivity to ticagrelor or ASA
Need for or an anticipated need for oral or intravenous therapy with any of the following:
Strong cytochrome P450 3A (CYP3A4) inhibitors (eg, ketoconazole, clarithromycin [but not erythromycin or azithromycin], nefazadone, ritonavir, atazanavir) that cannot be stopped for the course of the study
Long-term (>7 days) non-steroidal anti-inflammatory drugs
Known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)
Known severe liver disease (eg, ascites or signs of coagulopathy)
Renal failure requiring dialysis
Pregnancy or breastfeeding. Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Previous enrolment or randomisation in the present study
Participation in another clinical study with an investigational product at any time during the 30 days prior to randomisation (regardless of when treatment with the investigational product was discontinued)

Trial locations and contacts

387 sites in 28 countries.

Country

City, postcode or hospital

387 sites in 28 countries

China43 sites

Research Site
Baoji, 721008
Research Site
Baotou, 014016
Research Site
Beijing, 100049
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Beijing, 100070
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Beijing, 100191
Research Site
Changsha, 410013
Research Site
Changsha, 410078
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Changsha, 430033
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Chifeng, 024000
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Daqing, 163000
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Foshan, 528000
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Guangzhou, 510080
Research Site
Guangzhou, 510180
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Guangzhou, 510630
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Guiyang, 550004
Research Site
Haikou, 570311
Research Site
Hangzhou, 310009
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Hohhot, 010017
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Hohhot, 10050
Research Site
Jinan, 250001
Research Site
Jinzhou, 121004
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Liuzhou, 545006
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Nanchang, 330006
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Nanjing, 210029
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Nantong, 226001
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Ningbo, 315010
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Shanghai, 200080
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Shanghai, 200090
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Shanghai, CN-200120
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Shenyang, 110016
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Taiyuan, 030001
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Tangshan, 063001
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Tianjin, 300060
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Tianjin, 300121
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Wenzhou, 325000
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Wuhan, 430022
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Wuhan, 430033
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Wuhan, 430060
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Wuxi, 214002
Research Site
Xi'an, 710061
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Xiamen, 361004
Research Site
Xining, 810001
Research Site
Xuzhou, 221006

Other trials in China

Russia29 sites

Research Site
Chelyabinsk, 454106
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Izhevsk, 426063
Research Site
Kazan', 420012
Research Site
Kazan', 420101
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Kemerovo, 650002
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Moscow, 109004
Research Site
Moscow, 115516
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Moscow, 117292
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Moscow, 117997
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Moscow, 121374
Research Site
Moscow, 123367
Research Site
Nizhny Novgorod, 603005
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Nizhny Novgorod, 603018
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Novosibirsk, 630003
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Novosibirsk, 630051
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Ryazan, 390039
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Saint Petersburg, 192242
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Saint Petersburg, 194354
Research Site
Saint Petersburg, 196247
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Saint Petersburg, 196601
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Samara, 443095
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Samara, 443096
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Saratov, 410030
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Sochi, 354057
Research Site
Tomsk, 634063
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Ufa, 450071
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Voronezh, 394066
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Yaroslavl, 150030
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Yekaterinburg, 620102

Other trials in Russia

France26 sites

Research Site
Bayonne, 64100
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Besançon, 25030
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Bordeaux, 33076
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Bourg-en-Bresse, 01012
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Brest, 29609
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Caen, 14033
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Corbeil-Essonnes, 91106
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Dijon, 21079
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Le Chesnay, 78157
Research Site
Lille, 59037
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Metz, 57085
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Montpellier, 34295
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Nancy, 54035
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Nice, 06001
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Paris, 75019
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Paris, 75475
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Paris, 75571
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Paris, 75651
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Paris, 75877
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Rennes, 35033
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Rouen, 76031
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Saint-Herblain, 44093
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Saint-Priez En Jarez, 42270
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Strasbourg, 67098
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Suresnes, 92151
Research Site
Toulouse, 31059

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Poland23 sites

Research Site
Bialystok, 15-276
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Chełm, 22-100
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Działdowo, 13-200
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Gdansk, 80-803
Research Site
Gdansk, 80-952
Research Site
Gmina Końskie, 26-200
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Gmina Świebodzin, 66-200
Research Site
Grodzisk Mazowiecki, 05-825
Research Site
Gryfice, 72-300
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Katowice, 40-635
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Krakow, 31-826
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Lodz, 90-153
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Lodz, 93-113
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Lublin, 20-954
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Olsztyn, 10-082
Research Site
Olsztyn, 10-560
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Ostrołęka, 07-410
Research Site
Rybnik, 44-200
Research Site
Sandomierz, 27-600
Research Site
Skarżysko-Kamienna, 26-110
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Warsaw, 02-957
Research Site
Warsaw, 03-242
Research Site
Zielona Góra, 65-046

Other trials in Poland

India19 sites

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Bangalore, 560002
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Bangalore, 560068
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Bengaluru, 560076
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Dehradun, 248001
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Guntur, 522001
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Gūrgaon, 122001
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Gūrgaon, 122002
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Hyderabad, 500018
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Kanpur, 208002
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Kolkata, 700017
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Mangalore, 575002
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Nagpur, 420012
Research Site
Nagpur, 440012
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Nashik, 422005
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New Delhi, 110005
Research Site
New Delhi, 110026
Research Site
New Delhi, 110029
Research Site
Srikakulam, 532001
Research Site
Varanasi, 221004

Other trials in India

Italy19 sites

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Cona, 44124
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Genova, 16128
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Genova, 16132
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Massa, 55100
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Milan, 20132
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Modena, 41100
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Negrar, 37024
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Pavia, 27100
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Perugia, 06132
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Pietra Ligure, 17027
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Pisa, 56100
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Roma, 00144
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Roma, 00152
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Roma, 00161
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Siena, 53100
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Varese, 21100
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Verona, 37126
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Vicenza, 36100
Research Site
Vizzolo Predabissi, 20070

Other trials in Italy

South Korea17 sites

Research Site
Anyang-si, 14068
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Busan, 49201
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Busan, 49241
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Cheongju-si, 28644
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Daegu, 42415
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Daegu, 42601
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Daegu, 700-721
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Daejeon, 35233
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Goyang-si, 411-706
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Gwangju, 61469
Research Site
Incheon, 400-711
Research Site
Jeju-do, 63241
Research Site
Seongnam-si, 13620
Research Site
Seoul, 01830
Research Site
Seoul, 02053
Research Site
Seoul, 02447
Research Site
Seoul, 04401

Other trials in South Korea

Thailand17 sites

Research Site
Bangkok, 10220
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Bangkok, 10300
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Bangkok, 10330
Research Site
Bangkok, 10400
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Bangkok, 10600
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Bangkok, 10700
Research Site
Chon Buri, 20000
Research Site
Hat Yai, 90110
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Khlong Luang, 12120
Research Site
Khon Kaen, 40002
Research Site
Lampang, 52000
Research Site
Muang, 57000
Research Site
Nakhonpathom, 73000
Research Site
Prachinburi, 25000
Research Site
Rajthevi, 10400
Research Site
Ratchaburi, 70000
Research Site
Ubonratchathani, 34000

Other trials in Thailand

Hungary16 sites

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Baja, 6500
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Balassagyarmat, 2660
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Budapest, 1083
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Budapest, 1106
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Budapest, 1125
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Budapest, 1134
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Budapest, 1204
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Debrecen, 4043
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Győr, 9000
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Kistarcsa, 2143
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Miskolc, 3526
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Nyíregyháza, 4400
Research Site
Pécs, 7623
Research Site
Sopron-Balf, 9494
Research Site
Székesfehérvár, 8000
Research Site
Tatabánya, 2800

Other trials in Hungary

Taiwan16 sites

Research Site
Changhua, 500
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Kaohsiung City, 80756
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Kaohsiung City, 83301
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Keelung, 20448
Research Site
New Taipei City, 23561
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New Taipei City, 237
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Taichung, 40447
Research Site
Taichung, 40705
Research Site
Taichung, 437
Research Site
Tainan, 704
Research Site
Tainan, 710
Research Site
Taipei, 10002
Research Site
Taipei, 10449
Research Site
Taipei, 11101
Research Site
Taipei, 116
Research Site
Taoyuan Hsien, 33305

Other trials in Taiwan

Spain15 sites

Research Site
Albacete, 02006
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Alicante, 03010
Research Site
Badalona(Barcelona), 08916
Research Site
Barcelona, 08003
Research Site
Barcelona, 08025
Research Site
Barcelona, 08035
Research Site
Girona, 17007
Research Site
Lleida, 25198
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Madrid, 28006
Research Site
Madrid, 28034
Research Site
Seville, 41009
Research Site
Seville, 41013
Research Site
Valencia, 46009
Research Site
Valladolid, 47005
Research Site
Zaragoza, 50009

Other trials in Spain

Argentina14 sites

Research Site
Adrogué, 1846
Research Site
Buenos Aires, 1180AAX
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Buenos Aires, 1437
Research Site
Buenos Aires, AR-CP 1221
Research Site
Buenos Aires, C1425 FSD
Research Site
Buenos Aires, C1437BZK
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Capital Federal, 1428
Research Site
Ciudad Autónoma de Bs. As., C1199ABB
Research Site
Córdoba, 5000
Research Site
Mar del Plata, B7602CBM
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Mendoza, M5500IDN
Research Site
Rosario, S2000DSV
Research Site
Rosario, S200GAP
Research Site
Salta, A4400

Other trials in Argentina

Ukraine14 sites

Research Site
Chernivtsі, 58001
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Ivano-Frankivsk, 76008
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Ivano-Frankivsk, 76018
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Kharkiv Region, 61018
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Kharkiv Region, 61176
Research Site
Kherson, 73000
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Kyiv, 03129
Research Site
Lutsk, 43024
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Lviv, 79013
Research Site
Poltava, 36038
Research Site
Ternopil, 46027
Research Site
Vinnytsia, 21005
Research Site
Zaporizhzhya, 69068
Research Site
Zaporizhzhya, 69600

Other trials in Ukraine

Belgium13 sites

Research Site
Antwerp, 2020
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Assebroek (Brugge), 8310
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Bruges, 8000
Research Site
Brussels, 1200
Research Site
Dendermonde, 9200
Research Site
Edegem, 2650
Research Site
Kortrijk, 8500
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Ostend, 8400
Research Site
Roeselare, 8800
Research Site
Sint-Truiden, 3800
Research Site
Yvoir, 5530

Other trials in Belgium

Germany12 sites

Research Site
Altenburg, 04600
Research Site
Bad Neustadt an der Saale, 97616
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Berlin, 12351
Research Site
Erlangen, 91054
Research Site
Essen, 45147
Research Site
Hamburg, 20099
Research Site
Hamburg, 22043
Research Site
Hamburg, 22291
Research Site
Hamburg, 22763
Research Site
Hanover, 30625
Research Site
Minden, 32429
Research Site
Münster, 48149

Other trials in Germany

Slovakia11 sites

Research Site
Dolný Kubín, 02614
Research Site
Levoča, 054 01
Research Site
Liptovský Mikuláš, 031 23
Research Site
Martin, 03659
Research Site
Nitra, 949 01
Research Site
Rimavská Sobota, 97912
Research Site
Skalica, 909 82
Research Site
Spišská Nová Ves, 052 01
Research Site
Trenčín, 81171
Research Site
Trnava, 91701
Research Site
Žiar nad Hronom, 96537

Other trials in Slovakia

Bulgaria10 sites

Research Site
Dupnitsa, 2600
Research Site
Kozloduy, 3320
Research Site
Lukovit, 5770
Research Site
Pazardzhik, 4400
Research Site
Pleven, 5800
Research Site
Sliven, 8800
Research Site
Sofia, 1142
Research Site
Sofia, 1407
Research Site
Sofia, 1606
Research Site
Teteven, 5700

Other trials in Bulgaria

Mexico10 sites

Research Site
Culiacán, 80230
Research Site
D.F, 14269
Research Site
Durango, 34217
Research Site
Guadalajara, 44280
Research Site
México, 01090
Research Site
México, 03103
Research Site
Mexico City, 07760
Research Site
Mexico City, 6726
Research Site
Monterrey, 64460
Research Site
Tijuana, 22321

Other trials in Mexico

Sweden10 sites

Research Site
Gothenburg, 413 45
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Linköping, 581 85
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Lund, 221 85
Research Site
Malmö, 205 02
Research Site
Östersund, 831 83
Research Site
Skövde, 541 85
Research Site
Solna, 171 76
Research Site
Stockholm, 118 83
Research Site
Stockholm, 182 88
Research Site
Uppsala, 751 85

Other trials in Sweden

Brazil9 sites

Research Site
Botucatu, 18618-687
Research Site
Curitiba, 81210-310
Research Site
Goiânia, 74083-100
Research Site
Joinville, 89202-165
Research Site
Maringá, 87015-000
Research Site
Porto Alegre, 90610-000
Research Site
Ribeirão Preto, 14015130
Research Site
Rio de Janeiro, 22270-005
Research Site
Salvador, 41820011

Other trials in Brazil

Peru9 sites

Research Site
Bellavista, CALLAO 2
Research Site
Callao, CALLAO 02
Research Site
Lima, LIMA 01
Research Site
Lima, LIMA 13
Research Site
Lima, LIMA 1
Research Site
Lima, LIMA 31
Research Site
Lima, Lima-1
Research Site
Trujillo, 130101
Research Site
Urb. El Chipe, 20007

Other trials in Peru

Romania8 sites

Research Site
Bucharest, 011461
Research Site
Bucharest, 020125
Research Site
Bucharest, 050098
Research Site
Iași, 700309
Research Site
Oradea, 410169
Research Site
Sibiu, 550166
Research Site
Târgu Mureş, 540136
Research Site
Timișoara, 300736

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Czechia7 sites

Research Site
Brno, 656 91
Research Site
Chomutov, 430 12
Research Site
Ostrava, 703 84
Research Site
Ostrava, 708 52
Research Site
Pardubice, 520 03
Research Site
Prague, 140 59
Research Site
Ústí nad Labem, 401 13

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Australia6 sites

Research Site
Adelaide, 5000
Research Site
Heidelberg, 3084
Research Site
Herston, 4029
Research Site
Parkville, 3050
Research Site
Southport, 4215
Research Site
St Albans, 3021

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Canada4 sites

Research Site
Calgary, Alberta, T2N 2T9
Research Site
Chicoutimi, G7H 5H6
Research Site
Edmonton, Alberta, T6G 2B7
Research Site
Lethbridge, Alberta, T1J 0N9

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Saudi Arabia4 sites

Research Site
Jeddah, 21423
Research Site
Riyadh, 11426
Research Site
Riyadh, 11525
Research Site
Riyadh, 12372

Other trials in Saudi Arabia

Vietnam4 sites

Research Site
Đông Nãi, 81000
Research Site
Hà Nội, 10000
Research Site
Hanoi, 10000
Research Site
Ho Chi Minh City, 70000

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Hong Kong2 sites

Research Site
Hong Kong
Research Site
Kowloon

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About this study

Official title: A Randomised, Double-Blind, Placebo-Controlled, International, Multicentre, Phase III Study to Investigate the Efficacy and Safety of Ticagrelor and ASA Compared With ASA in the Prevention of Stroke and Death in Patients With Acute Ischaemic Stroke or Transient Ischaemic Attack

Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo (inactive tablet) and ASA in preventing new stroke events

Conditions: Acute Ischaemic Stroke, Transient Ischaemic Attack
Being tested: Ticagrelor, Placebo
Keywords: Acute ischaemic stroke; Transient Ischaemic Attack (TIA); Stroke
Medical subject headings: Ischemic Attack, Transient, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TicagrelorDrug
Ticagrelor arm: Day 1, loading dose of ticagrelor followed by daily maintenance dose until Day 30.
PlaceboDrug
Placebo arm: Day 1, loading dose of placebo followed by placebo daily maintenance dose until Day 30.

Study groups in NCT03354429
Study group	Role	What they receive
TICAGRELOR	Experimental	Not described Receives: Drug: Ticagrelor
TICAGRELOR PLACEBO	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite of Subsequent Stroke or Death
Participants with subsequent stroke or death
Measured: From randomisation (day 1) to visit 3 (day 30-34)

Secondary outcomes (2)

Ischaemic Stroke
Number of participants with ischaemic stroke
Measured: From randomisation (day 1) to visit 3 (day 30-34)
Number of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 3
The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.0 - No symptoms,1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Measured: Visit 3 (day 30-34)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 201813 Dec 2019

First posted28 Nov 2017
Study start22 Jan 2018
Primary completion13 Dec 2019
Study completion13 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Acute Ischaemic StrokeStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 11,016 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03354429
Sponsor's protocol ID: D5134C00003
Other IDs: 2016-004232-37, 2016
Acronym: THALES
Status last verified: Dec 2020
First submitted: 20 Nov 2017
Last updated: 22 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Tank A, Johnston SC, Jain R, Amarenco P, Mellstrom C, Rikner K, Denison H, Ladenvall P, Knutsson M, Himmelmann A, Evans SR, James S, Molina CA, Wang Y, Ouwens M. Cost-effectiveness of ticagrelor plus aspirin versus aspirin in acute ischaemic stroke or transient ischaemic attack: an economic evaluation of the THALES trial. BMJ Neurol Open. 2023 Aug 24;5(2):e000478. doi: 10.1136/bmjno-2023-000478. eCollection 2023.
PubMed 37637218
Johnston SC, Amarenco P, Aunes M, Denison H, Evans SR, Himmelmann A, Jahreskog M, James S, Knutsson M, Ladenvall P, Molina CA, Nylander S, Rother J, Wang Y; THALES Investigators. Ischemic Benefit and Hemorrhage Risk of Ticagrelor-Aspirin Versus Aspirin in Patients With Acute Ischemic Stroke or Transient Ischemic Attack. Stroke. 2021 Nov;52(11):3482-3489. doi: 10.1161/STROKEAHA.121.035555. Epub 2021 Sep 3.
PubMed 34477459
Wang Y, Pan Y, Li H, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Birve F, Ladenvall P, Molina CA, Johnston SC; THALES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor and Aspirin in Patients With Moderate Ischemic Stroke: An Exploratory Analysis of the THALES Randomized Clinical Trial. JAMA Neurol. 2021 Sep 1;78(9):1091-1098. doi: 10.1001/jamaneurol.2021.2440.
PubMed 34244703
Yaghi S, de Havenon A, Rostanski S, Kvernland A, Mac Grory B, Furie KL, Kim AS, Easton JD, Johnston SC, Henninger N. Carotid Stenosis and Recurrent Ischemic Stroke: A Post-Hoc Analysis of the POINT Trial. Stroke. 2021 Jul;52(7):2414-2417. doi: 10.1161/STROKEAHA.121.034089. Epub 2021 May 4.
PubMed 33940954
Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y, Johnston SC; THALES Steering Committee and Investigators*. Ticagrelor Added to Aspirin in Acute Nonsevere Ischemic Stroke or Transient Ischemic Attack of Atherosclerotic Origin. Stroke. 2020 Dec;51(12):3504-3513. doi: 10.1161/STROKEAHA.120.032239. Epub 2020 Nov 16.
PubMed 33198608
Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y, Johnston SC; THALES Steering Committee and Investigators. Ticagrelor Added to Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack in Prevention of Disabling Stroke: A Randomized Clinical Trial. JAMA Neurol. 2020 Nov 7;78(2):1-9. doi: 10.1001/jamaneurol.2020.4396. Online ahead of print.
PubMed 33159526
Johnston SC, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y; THALES Investigators. Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA. N Engl J Med. 2020 Jul 16;383(3):207-217. doi: 10.1056/NEJMoa1916870.
PubMed 32668111
Johnston SC, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y; THALES Investigators. The Acute Stroke or Transient Ischemic Attack Treated with Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) trial: Rationale and design. Int J Stroke. 2019 Oct;14(7):745-751. doi: 10.1177/1747493019830307. Epub 2019 Feb 12.
PubMed 30747613
Wong KSL, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Himmelmann A, Kasner SE, Knutsson M, Ladenvall P, Minematsu K, Molina CA, Wang Y, Johnston SC; SOCRATES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor in Relation to Aspirin Use Within the Week Before Randomization in the SOCRATES Trial. Stroke. 2018 Jul;49(7):1678-1685. doi: 10.1161/STROKEAHA.118.020553. Epub 2018 Jun 18.
PubMed 29915123

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Ischaemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-Blind, Placebo-Controlled, International, Multicentre, Phase III Study to Investigate the Efficacy and Safety of Ticagrelor and ASA Compared With ASA in the Prevention of Stroke and Death in Patients With Acute Ischaemic Stroke or Transient Ischaemic Attack
ClinicalTrials.gov ID: NCT03354429
Acronym / sponsor ID: THALES / D5134C00003
Conditions: Acute Ischaemic Stroke, Transient Ischaemic Attack
Keywords: Acute ischaemic stroke; Transient Ischaemic Attack (TIA); Stroke
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 11,016 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 22 Jan 2018 (actual)
Primary completion: 13 Dec 2019 (actual)
Study completion: 13 Dec 2019 (actual)
First posted: 28 Nov 2017 (actual)
Results: Posted 22 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo (inactive tablet) and ASA in preventing new stroke events

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TICAGRELOR	Experimental	Drug: Ticagrelor
TICAGRELOR PLACEBO	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 40 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Provision of signed informed consent prior to any study-specific procedure
≥40 years of age
Acute onset of cerebral ischaemia due to
Randomisation occurring within 24 hours after onset of symptoms; for wake-up strokes (when the time of symptom onset is not known), within 24 hours from the time point at which the patient was reported to be in their normal condition
CT or MRI performed after symptom onset ruling out intracranial haemorrhage or other pathology, such as vascular malformation, tumour, or abscess that according

Key exclusion criteria (21 listed)

Need for or an anticipated need for any of the following:
Any history of atrial fibrillation/flutter, ventricular aneurysm, or suspicion of other cardioembolic pathology for TIA or stroke
Patients who should receive or have received any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation
Planned carotid endarterectomy that requires halting investigational product within 3 days of randomisation or is expected to require unblinding of investigational product (planned carotid endarterectomy is in itself not an exclusion criterion)
History of previous intracranial haemorrhage at any time (asymptomatic microbleeds do not qualify), gastrointestinal haemorrhage within the past 6 months, or major surgery within 30 days

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TicagrelorTicagrelor arm: Day 1, loading dose of ticagrelor followed by daily maintenance dose until Day 30.	Drug	TICAGRELOR
PlaceboPlacebo arm: Day 1, loading dose of placebo followed by placebo daily maintenance dose until Day 30.	Drug	TICAGRELOR PLACEBO

Primary outcome

Composite of Subsequent Stroke or Death
Time frame: From randomisation (day 1) to visit 3 (day 30-34)
Participants with subsequent stroke or death

2 secondary outcomes

Ischaemic Stroke
Time frame: From randomisation (day 1) to visit 3 (day 30-34)
Number of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 3
Time frame: Visit 3 (day 30-34)

Results and safety

Results posted to the registry on 22 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TICAGRELOR	5,523	5,514
PLACEBO	5,493	5,486

Primary outcome: Composite of Subsequent Stroke or Death

Time frame: From randomisation (day 1) to visit 3 (day 30-34). Count of participants. Unit: Participants

Measure	TICAGRELOR n = 5523	PLACEBO n = 5493
Value	303	362

TICAGRELOR vs PLACEBO: Hazard Ratio (HR): 0.83 (95% CI 0.71 to 0.96), p = 0.015, Regression, Cox

Population analysed: Full analysis set including all randomised patients

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From randomisation (day 1) to visit 3 (day 30-34). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ticagrelor	571 of 5,523 (10.3%)	0 of 5,523 (0%)	40 of 5,523
Placebo	609 of 5,493 (11.1%)	0 of 5,493 (0%)	32 of 5,493

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37637218Tank A, Johnston SC, Jain R, Amarenco P, Mellstrom C, Rikner K, Denison H, Ladenvall P, Knutsson M, Himmelmann A, Evans SR, James S, Molina CA, Wang Y, Ouwens M. Cost-effectiveness of ticagrelor plus aspirin versus aspirin in acute ischaemic stroke or transient ischaemic attack: an economic evaluation of the THALES trial. BMJ Neurol Open. 2023 Aug 24;5(2):e000478. doi: 10.1136/bmjno-2023-000478. eCollection 2023.
Derived from this study: PubMed 34477459Johnston SC, Amarenco P, Aunes M, Denison H, Evans SR, Himmelmann A, Jahreskog M, James S, Knutsson M, Ladenvall P, Molina CA, Nylander S, Rother J, Wang Y; THALES Investigators. Ischemic Benefit and Hemorrhage Risk of Ticagrelor-Aspirin Versus Aspirin in Patients With Acute Ischemic Stroke or Transient Ischemic Attack. Stroke. 2021 Nov;52(11):3482-3489. doi: 10.1161/STROKEAHA.121.035555. Epub 2021 Sep 3.
Derived from this study: PubMed 34244703Wang Y, Pan Y, Li H, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Birve F, Ladenvall P, Molina CA, Johnston SC; THALES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor and Aspirin in Patients With Moderate Ischemic Stroke: An Exploratory Analysis of the THALES Randomized Clinical Trial. JAMA Neurol. 2021 Sep 1;78(9):1091-1098. doi: 10.1001/jamaneurol.2021.2440.
Derived from this study: PubMed 33940954Yaghi S, de Havenon A, Rostanski S, Kvernland A, Mac Grory B, Furie KL, Kim AS, Easton JD, Johnston SC, Henninger N. Carotid Stenosis and Recurrent Ischemic Stroke: A Post-Hoc Analysis of the POINT Trial. Stroke. 2021 Jul;52(7):2414-2417. doi: 10.1161/STROKEAHA.121.034089. Epub 2021 May 4.
Derived from this study: PubMed 33198608Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y, Johnston SC; THALES Steering Committee and Investigators*. Ticagrelor Added to Aspirin in Acute Nonsevere Ischemic Stroke or Transient Ischemic Attack of Atherosclerotic Origin. Stroke. 2020 Dec;51(12):3504-3513. doi: 10.1161/STROKEAHA.120.032239. Epub 2020 Nov 16.
Derived from this study: PubMed 33159526Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y, Johnston SC; THALES Steering Committee and Investigators. Ticagrelor Added to Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack in Prevention of Disabling Stroke: A Randomized Clinical Trial. JAMA Neurol. 2020 Nov 7;78(2):1-9. doi: 10.1001/jamaneurol.2020.4396. Online ahead of print.
Derived from this study: PubMed 32668111Johnston SC, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y; THALES Investigators. Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA. N Engl J Med. 2020 Jul 16;383(3):207-217. doi: 10.1056/NEJMoa1916870.
Derived from this study: PubMed 30747613Johnston SC, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y; THALES Investigators. The Acute Stroke or Transient Ischemic Attack Treated with Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) trial: Rationale and design. Int J Stroke. 2019 Oct;14(7):745-751. doi: 10.1177/1747493019830307. Epub 2019 Feb 12.
Derived from this study: PubMed 29915123Wong KSL, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Himmelmann A, Kasner SE, Knutsson M, Ladenvall P, Minematsu K, Molina CA, Wang Y, Johnston SC; SOCRATES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor in Relation to Aspirin Use Within the Week Before Randomization in the SOCRATES Trial. Stroke. 2018 Jul;49(7):1678-1685. doi: 10.1161/STROKEAHA.118.020553. Epub 2018 Jun 18.
redacted SAPLink provided by the sponsor.
redacted CSPLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

387 sites in 28 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor in people with Acute Ischaemic Stroke and Transient Ischaemic Attack, run by AstraZeneca at 387 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 387 sites in China, Russia, France, Poland, India and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Subsequent Stroke or Death (time frame: From randomisation (day 1) to visit 3 (day 30-34)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03354429, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.