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AzTrials

Coronary Artery Disease (CAD)Phase 3NCT01813435

GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

A Phase 3 study testing Ticagrelor, Acetylsalicylic Acid and Clopidogrel in people with Coronary Artery Disease (CAD), run by ECRI bv at 130 sites in 18 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

After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease (CAD)
What is being tested?
Ticagrelor, Acetylsalicylic Acid and Clopidogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15,991 participants
Where
130 sitesin 18 countries
Study dates
1 Jul 2013to 26 Apr 2018
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -"All comer" patients
  • Age ≥18 years;
  • Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.25 mm (no limitation on the number of treated lesions, vessels, or lesion length);
  • Able to provide informed consent and willing to participate in 2 year follow- up period.

Who cannot join

  • Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus;
  • Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor;
  • Known moderate to severe hepatic impairment (alanine-aminotransferase ≥ 3 x ULN);
  • Planned surgery, including coronary artery bypass graft (CABG) as a staged procedure (hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
  • Need for chronic oral anti-coagulation therapy;
  • Active major bleeding or major surgery within the last 30 days;
Show all 11Show fewer
  • Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm;
  • Known stroke (any type) within the last 30 days;
  • Known pregnancy at time of randomisation;
  • Female who is breastfeeding at time of randomisation;
  • Currently participating in another trial and not yet at its primary endpoint.

Trial locations and contacts

130 sites in 18 countries.

130 sites in 18 countries

United Kingdom18 sites

  • Research centre Belfast, 4420

    Belfast

  • Research Centre Belfast, 4423

    Belfast

  • Research centre Blackburn, 4404

    Blackburn

  • Research centre Blackpool, 4408

    Blackpool

  • Research centre Bournemouth, 4418

    Bournemouth

  • Research centre Brighton, 4405

    Brighton

  • Research centre Cambridge, 4417

    Cambridge

  • Research centre Cardiff, 4402

    Cardiff

  • Research centre Glasgow, 4407

    Glasgow

  • Research centre Leicester, 4421

    Leicester

  • Research centre Liverpool, 4001

    Liverpool

  • Research centre Manchester, 4403

    Manchester

  • Research centre Manchester, 4406

    Manchester

  • Research centre Newcastle, 4413

    Newcastle

  • Research centre Rhyl, 4414

    Rhyl

  • Research centre Southampton, 4415

    Southampton

  • Research centre Stevenage, 4412

    Stevenage

  • Research centre Wolverhampton, 4422

    Wolverhampton

Other trials in United Kingdom

Germany17 sites

  • Research centre Bad Krozingen, 4904

    Bad Krozingen

  • Research centre Bad Nauheim, 4902

    Bad Nauheim

  • Research centre Berlin, 4918

    Berlin

  • Research centre Bonn, 4911

    Bonn

  • Research centre Dresden, 4908

    Dresden

  • Research centre Essen, 4903

    Essen

  • Research centre Fulda, 4905

    Fulda

  • Research centre Giessen 4901

    Giessen

  • Research centre Göttingen, 4907

    Göttingen

  • Research centre Landshut, 4909

    Landshut

  • Research centre Lubeck, 4917

    Lübeck

  • Research centre Mainz, 4910

    Mainz

  • Research centre Mannheim, 4912

    Mannheim

  • Research centre Mönchengladbach, 4915

    Mönchengladbach

  • Research centre Neuss, 4916

    Neuss

  • Research centre Tubingen, 4914

    Tübingen

  • Research centre Villingen - Schwenningen, 4919

    Villingen-Schwenningen

Other trials in Germany

France13 sites

  • Research centre Aix en Provence, 3311

    Aix-en-Provence

  • Research centre Caen, 3308

    Caen

  • Research centre Caen, 3309

    Caen

  • Research centre Clermont-Ferrand, 3303

    Clermont-Ferrand

  • Research centre Dijon, 3313

    Dijon

  • Research centre Grenoble, 3312

    Grenoble

  • Research centre Lyon, 3316

    Lyon

  • Research centre Nancy, 3314

    Nancy

  • Research centre Paris, 3301

    Paris

  • Research centre Paris, 3305

    Paris

  • Research centre Rouen, 3307

    Rouen

  • Research centre Saint Etienne, 3310

    Saint-Etienne

  • Research centre Toulouse, 3302

    Toulouse

Other trials in France

Netherlands9 sites

  • Research centre Alkmaar, 3106

    Alkmaar

  • OLVG Research centre Amsterdam, 3104

    Amsterdam

  • UMCG Groningen, 3108

    Groningen

  • Research centre Leeuwarden, 3102

    Leeuwarden

  • Research centre Nieuwegein, 3107

    Nieuwegein

  • Research centre Nijmegen, 3105

    Nijmegen

  • EMC Rotterdam, 3101

    Rotterdam

  • Maasstad Rotterdam, 3103

    Rotterdam

  • Research centre Tilburg, 3109

    Tilburg

Other trials in Netherlands

Spain9 sites

  • Research centre Barcelona, 3401

    Barcelona

  • Research centre Barcelona, 3403

    Barcelona

  • Research centre Barcelona, 3405

    Barcelona

  • Research centre Huelva, 3408

    Huelva

  • Research centre Madrid 3410

    Madrid

  • Research centre Madrid, 3402

    Madrid

  • Research centre Madrid, 3407

    Madrid

  • Research centre Madrid, 3409

    Madrid

  • Research centre Vigo, 3404

    Vigo

Other trials in Spain

Bulgaria8 sites

  • Research centre Burgas, 9902

    Burgas

  • Research centre Plovdiv, 9905

    Plovdiv

  • Research centre Sofia, 9901

    Sofia

  • Research centre Sofia, 9903

    Sofia

  • Research centre Sofia, 9904

    Sofia

  • Research centre Sofia, 9907

    Sofia

  • Research centre Sofia, 9908

    Sofia

  • Research centre Varna, 9906

    Varna

Other trials in Bulgaria

Hungary8 sites

  • Research centre Balatonfüred, 3608

    Balatonfüred

  • Research centre Budapest, 3602

    Budapest

  • Research centre Budapest, 3603

    Budapest

  • Research centre Debrecen, 3607

    Debrecen

  • Research centre Gyula, 3606

    Gyula

  • Research centre Nyíregyháza, 3605

    Nyíregyháza

  • Research centre Pécs, 3604

    Pécs

  • Research centre szeged, 3601

    Szeged

Other trials in Hungary

Poland7 sites

  • Research centre Chrzanow, 4802

    Chrzanów

  • Research centre Dabrowa Gornicza, 4801

    Dąbrowa Górnicza

  • Research centre Kedzierzyn-Kozle, 4805

    Kędzierzyn-Koźle

  • Research centre Krakov, 4807

    Krakow

  • Research centre Mielec, 4809

    Mielec

  • Research centre Nysa, 4808

    Nysa

  • Research centre Ustroń, 4803

    Ustroń

Other trials in Poland

Belgium6 sites

  • Research centre Aalst, 3201

    Aalst

  • Research centre Aalst, 3206

    Aalst

  • Research centre Bonheiden, 3204

    Bonheiden

  • Research centre Charleroi, 3202

    Charleroi

  • Research centre Genk, 3205

    Genk

  • Research centre Hasselt, 3203

    Hasselt

Other trials in Belgium

Italy6 sites

  • Research centre Arezzo, 3902

    Arezzo

  • Research centre Brescia, 3912

    Brescia

  • Research centre Ferrara, 3905

    Ferrara

  • Research centre Milano, 3901

    Milan

  • Research centre Pavia, 3903

    Pavia

  • Research centre Terni, 3909

    Terni

Other trials in Italy

Switzerland6 sites

  • Research centre Bern, 4106

    Bern

  • Research centre Bern, 4107

    Bern

  • Research centre Geneva, 4101

    Geneva

  • Research centre Lausanne, 4104

    Lausanne

  • Research centre Liestal, 4108

    Liestal

  • Research centre Lugano, 4105

    Lugano

Other trials in Switzerland

Austria5 sites

  • Research centre Graz, 4305

    Graz

  • Rsearch centre Innsbruck, 4303

    Innsbruck

  • Research centre Linz, 4304

    Linz

  • Research centre Vienna, 4301

    Vienna

  • Research centre Vienna, 4302

    Vienna

Other trials in Austria

Brazil5 sites

  • Research centre Rio de Janeiro, 5503

    Rio de Janeiro

  • Research centre Rio de Janeiro, 5504

    Rio de Janeiro

  • Research centre Sao Paulo, 5501

    São Paulo

  • Research centre Sao Paulo, 5502

    São Paulo

  • Research centre Uberlândia, 5505

    Uberlândia

Other trials in Brazil

Portugal4 sites

  • Research centre Gaia, 3501

    Gaia

  • Research centre Lisbon, 3503

    Lisbon

  • Research centre Lisbon, 3504

    Lisbon

  • Research centre Lisbon, 3505

    Lisbon

Other trials in Portugal

Australia3 sites

  • Research centre Brisbane, 6101

    Brisbane

  • Research centre Melbourne, 6104

    Melbourne

  • Research centre Melbourne, 6105

    Melbourne

Other trials in Australia

Canada2 sites

  • Research centre Newmarket, 1003

    Newmarket

  • Research centre Quebec, 1001

    Québec

Other trials in Canada

Denmark2 sites

  • Research centre Copenhagen, 4501

    Copenhagen

  • Research centre Roskilde, 4503

    Roskilde

Other trials in Denmark

Singapore2 sites

  • Research centre Singapore, 6501

    Singapore

  • Research centre Singapore, 6502

    Singapore

Other trials in Singapore

About this study

After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.

There are two medication strategies:

  • Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR
  • Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely
Read the detailed description

The study objective is to determine in all-comers patients undergoing percutaneous coronary intervention (PCI) under standardised treatment (including the BioMatrix family of drug-eluting stents and bivalirudin), whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy is superior with respect to the composite of all-cause mortality or non-fatal new Q-wave myocardial infarction (MI) compared to treatment with 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.

The study design is an investigator-initiated, prospective randomised, multi-centre, multi-national, open-label trial to be conducted in approximately 60-80 interventional cardiology centres in Europe, North America, South America and Asia-Pacific. Patients will be randomised at a 1:1 ratio to study or reference treatment strategy.

Randomisation will occur at the time of the index procedure prior to PCI. Subjects will be stratified according to centre and according to the clinical presentation (Stable Coronary Artery Disease (CAD) vs. Acute Coronary Syndrome (ACS)).

All patients will be followed for a period of 2 years.

Being tested
Ticagrelor, Acetylsalicylic Acid, Clopidogrel
Keywords
CAD, ACS, All comers, DAPT, PCI
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • TicagrelorDrug

    Also called Brilique

    Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.

  • Acetylsalicylic AcidDrug

    Also called Aspirin, B01AC06

    Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy

  • ClopidogrelDrug

    Also called Plavix, B01AC04

    Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.

    Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy

Study groups in NCT01813435
Study groupRoleWhat they receive
Experimental treatment strategyExperimentalAll patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy. Dosage and frequency: Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)
Receives: Drug: Ticagrelor; Drug: Acetylsalicylic Acid
Reference treatment strategyActive comparatorAcute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy. Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy. Dosage and frequency: Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd
Receives: Drug: Ticagrelor; Drug: Acetylsalicylic Acid; Drug: Clopidogrel

What is being measured

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

  1. Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)

    Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.

    Measured: 2 year

Secondary outcomes (8)

  1. Number of Participants With All-cause Mortality

    Measured: 2-year

  2. Number of Participants With Myocardial Infarction

    Measured: 2 year

  3. Number of Participants With New Q-wave Myocardial Infarction

    Measured: 2-year

  4. Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction

    shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded

    Measured: 2-year

  5. Number of Participants With a Stroke

    Measured: 2 year

  6. Number of Participants With a Myocardial Revascularisation

    Measured: 2 year

  7. Number of Participants With a Definite Stent Thrombosis

    Measured: 2 year

  8. Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding

    BARC definition. We only considered BARC 3 or 5 for this secondary safety endpoint.

    Type 3: Clinical, laboratory, and/or imaging evidence of bleeding with:

    • Type 3a:
    • Overt bleeding + Hb drop of 3 to < 5 g/dL (provided Hb drop is related to bleed)
    • Any transfusion with overt bleeding
    • Type 3b:
    • Overt bleeding + Hb drop ≥5 g/dL (provided Hb drop is related to bleed)
    • Cardiac tamponade
    • Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid)
    • Bleeding requiring intravenous vasoactive agents
    • Type 3c:
    • Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal)
    • Subcategories confirmed by autopsy or imaging or lumbar puncture
    • Intraocular bleed compromising vision. Type 5: Fatal bleeding
    • Type 5a:
    • Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious
    • Type 5b:
    • Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation

    Measured: 2 year

Timeline

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

  1. First posted19 Mar 2013 (estimated)
  2. Study start1 Jul 2013
  3. Primary completion9 Nov 2015
  4. Study completion26 Apr 2018

Resources

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
None (open label)
Enrolment
15,991 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01813435
Sponsor's protocol ID
ECRI-12-001, 02EU11
Status last verified
Mar 2022
First submitted
12 Feb 2013
Last updated
15 Mar 2022
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Vranckx P, Valgimigli M, Juni P, Hamm C, Steg PG, Heg D, van Es GA, McFadden EP, Onuma Y, van Meijeren C, Chichareon P, Benit E, Mollmann H, Janssens L, Ferrario M, Moschovitis A, Zurakowski A, Dominici M, Van Geuns RJ, Huber K, Slagboom T, Serruys PW, Windecker S; GLOBAL LEADERS Investigators. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. Lancet. 2018 Sep 15;392(10151):940-949. doi: 10.1016/S0140-6736(18)31858-0. Epub 2018 Aug 27.

    PubMed 30166073

  • Woelders ECI, Onuma Y, Ninomiya K, O'Leary N, Damman P, Peeters DAM, Hof AWJV', Valgimigli M, Vranckx P, Windecker S, Serruys PWJC, van Geuns RM. Parsimonious versus extensive bleeding score: can we simplify risk stratification after percutaneous coronary intervention and reduce bleeding events by de-escalation of the antiplatelet strategy? Open Heart. 2025 Jan 28;12(1):e003083. doi: 10.1136/openhrt-2024-003083.

    PubMed 39875171

  • Ono M, Hara H, Kawashima H, Gao C, Wang R, Wykrzykowska JJ, Piek JJ, Garg S, Hamm C, Steg PG, Valgimigli M, Windecker S, Vranckx P, Onuma Y, Serruys PW. Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial. EuroIntervention. 2022 Aug 5;18(5):e377-e388. doi: 10.4244/EIJ-D-21-00870.

    PubMed 35260381

  • Gragnano F, Zwahlen M, Vranckx P, Heg D, Schmidlin K, Hamm C, Steg PG, Gargiulo G, McFadden EP, Onuma Y, Chichareon P, Benit E, Mollmann H, Janssens L, Leonardi S, Zurakowski A, Arrivi A, Van Geuns RJ, Huber K, Slagboom T, Calabro P, Serruys PW, Juni P, Valgimigli M, Windecker S; GLOBAL LEADERS Investigators [Link]. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2022 May 17;11(10):e024291. doi: 10.1161/JAHA.121.024291. Epub 2022 Mar 1.

    PubMed 35229616

  • Westra J, Eftekhari A, Renkens M, Mejia-Renteria H, Sejr-Hansen M, Stegehuis V, Holm NR, de Winter RJ, Piek JJ, Escaned J, Wykrzykowska JJ, Christiansen EH. Characterization of quantitative flow ratio and fractional flow reserve discordance using doppler flow and clinical follow-up. Int J Cardiovasc Imaging. 2022 Jun;38(6):1181-1190. doi: 10.1007/s10554-022-02522-1. Epub 2022 Jan 18.

    PubMed 35041147

  • Vranckx P, Valgimigli M, Odutayo A, Serruys PW, Hamm C, Steg PG, Heg D, Mc Fadden EP, Onuma Y, Benit E, Janssens L, Diletti R, Ferrario M, Huber K, Raber L, Windecker S, Juni P; GLOBAL LEADERS Investigators. Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre-Specified Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2021 Sep 21;10(18):e015560. doi: 10.1161/JAHA.119.015560. Epub 2021 Sep 17.

    PubMed 34533034

  • Gao C, Tomaniak M, Takahashi K, Kawashima H, Wang R, Hara H, Ono M, Montalescot G, Garg S, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, van Geuns RJ, Hamm C, Steg PG, Onuma Y, Angiolillo DJ, Serruys PW. Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial. Cardiovasc Diabetol. 2020 Oct 16;19(1):179. doi: 10.1186/s12933-020-01153-x.

    PubMed 33066794

  • Kawashima H, Tomaniak M, Ono M, Wang R, Hara H, Gao C, Takahashi K, Sharif F, Thury A, Suryapranata H, Walsh S, Cotton J, Carrie D, Sabate M, Steinwender C, Leibundgut G, Wykrzykowska J, de Winter RJ, Garg S, Hamm C, Steg PG, Juni P, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW. Safety and Efficacy of 1-Month Dual Antiplatelet Therapy (Ticagrelor + Aspirin) Followed by 23-Month Ticagrelor Monotherapy in Patients Undergoing Staged Percutaneous Coronary Intervention (A Sub-Study from GLOBAL LEADERS). Am J Cardiol. 2021 Jan 1;138:1-10. doi: 10.1016/j.amjcard.2020.09.057. Epub 2020 Oct 13.

    PubMed 33065080

  • Gao C, Takahashi K, Garg S, Hara H, Wang R, Kawashima H, Ono M, Montalescot G, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, Hamm C, Steg PG, Storey R, van Geuns RJ, Tao L, Onuma Y, Serruys PW. Regional variation in patients and outcomes in the GLOBAL LEADERS trial. Int J Cardiol. 2021 Feb 1;324:30-37. doi: 10.1016/j.ijcard.2020.09.039. Epub 2020 Sep 15.

    PubMed 32941872

  • Hara H, Takahashi K, Kogame N, Tomaniak M, Kerkmeijer LSM, Ono M, Kawashima H, Wang R, Gao C, Wykrzykowska JJ, de Winter RJ, Neumann FJ, Plante S, Lemos Neto PA, Garg S, Juni P, Vranckx P, Windecker S, Valgimigli M, Hamm C, Steg PG, Onuma Y, Serruys PW. Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2020 Sep;13(9):e009177. doi: 10.1161/CIRCINTERVENTIONS.120.009177. Epub 2020 Aug 25.

    PubMed 32838554

  • Hara H, van Klaveren D, Takahashi K, Kogame N, Chichareon P, Modolo R, Tomaniak M, Ono M, Kawashima H, Wang R, Gao C, Niethammer M, Fontos G, Angioi M, Ribeiro VG, Barbato E, Leandro S, Hamm C, Valgimigli M, Windecker S, Juni P, Steg PG, Verbeeck J, Tijssen JGP, Sharif F, Onuma Y, Serruys PW; GLOBAL LEADERS Trial Investigators. Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events. Circ Cardiovasc Qual Outcomes. 2020 Aug;13(8):e006660. doi: 10.1161/CIRCOUTCOMES.120.006660. Epub 2020 Jul 30.

    PubMed 32762446

  • Ono M, Chichareon P, Tomaniak M, Kawashima H, Takahashi K, Kogame N, Modolo R, Hara H, Gao C, Wang R, Walsh S, Suryapranata H, da Silva PC, Cotton J, Koning R, Akin I, Rensing BJWM, Garg S, Wykrzykowska JJ, Piek JJ, Juni P, Hamm C, Steg PG, Valgimigli M, Windecker S, Storey RF, Onuma Y, Vranckx P, Serruys PW. The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial. Clin Res Cardiol. 2020 Sep;109(9):1125-1139. doi: 10.1007/s00392-020-01604-1. Epub 2020 Jan 31.

    PubMed 32006156

  • Tomaniak M, Chichareon P, Klimczak-Tomaniak D, Takahashi K, Kogame N, Modolo R, Wang R, Ono M, Hara H, Gao C, Kawashima H, Rademaker-Havinga T, Garg S, Curzen N, Haude M, Kochman J, Gori T, Montalescot G, Angiolillo DJ, Capodanno D, Storey RF, Hamm C, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW, Anderson R. Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial. Clin Res Cardiol. 2020 Jul;109(7):930-943. doi: 10.1007/s00392-019-01586-9. Epub 2020 Jan 10.

    PubMed 31925529

  • Tomaniak M, Chichareon P, Takahashi K, Kogame N, Modolo R, Chang CC, Spitzer E, Neumann FJ, Plante S, Hernandez Antolin R, Jambrik Z, Gelev V, Brunel P, Konteva M, Beygui F, Morelle JF, Filipiak KJ, van Geuns RJ, Soliman O, Tijssen J, Rademaker-Havinga T, Storey RF, Hamm C, Steg PG, Windecker S, Onuma Y, Valgimigli M, Serruys PW; GLOBAL LEADERS Study Investigators. Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial. Eur Heart J Cardiovasc Pharmacother. 2020 Jul 1;6(4):222-230. doi: 10.1093/ehjcvp/pvz052.

    PubMed 31876907

  • Tomaniak M, Chichareon P, Modolo R, Takahashi K, Chang CC, Kogame N, Spitzer E, Buszman PE, van Geuns RM, Valkov V, Steinwender C, Geisler T, Prokopczuk J, Sabate M, Zmudka K, Rademaker-Havinga T, Tijssen JGP, Juni P, Hamm C, Steg PG, Onuma Y, Vranckx P, Valgimigli M, Windecker S, Baber U, Anderson R, Dominici M, Serruys PW. Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial. EuroIntervention. 2020 Apr 3;15(18):e1605-e1614. doi: 10.4244/EIJ-D-19-00699.

    PubMed 31845894

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor, Acetylsalicylic Acid and Clopidogrel in people with Coronary Artery Disease (CAD), run by ECRI bv at 130 sites in 18 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 4 inclusion and 11 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 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in United Kingdom, Germany, France, Netherlands, Spain and 13 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. 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 5 Jul 2019). 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?

Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI) (time frame: 2 year). 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 NCT01813435, which also lists 20 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 15 Mar 2022.

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