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Acute Ischemic StrokePhase 2NCT05281549

Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-II）

A Phase 2 study testing Alteplase and Tenecteplase in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 28 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The trial is prospective, block randomized, open-label, blinded endpoint (PROBE) design. Patients with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be randomized 1:1:1 to 0.25mg/kg or 0.40mg/kg intravenous tenecteplase or 0.9 mg/kg alteplase before… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Alteplase and Tenecteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
28 sitesChina
Study dates
2 May 2021to 31 May 2022
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Age ≥18 years old;
  • The clinical diagnosis was Acute ischemic stroke The time from onset to treatment was < 4.5h; The time at which symptoms begin is defined as "the time at which they finally appear normal";
  • mRS before onset was ≤1 points;
  • Baseline NIHSS (at the time of randomization) should be > 5 and ≤25 points;
  • Informed consent from the patient or surrogate.

Who cannot join

  • Intracranial hemorrhage identified by CT or MRI (CMBs detected by SWI is not counted);
  • Massive anterior cerebral infarction identified by CT or MRI (ASPECT < 6 or lesions larger than one third of the territory of the middle cerebral artery or with a volume larger than 70mL)
  • A history of severe CNS damage (such as aneurysm or arteriovenous malformation, craniocerebral trauma, intracranial or spinal cord surgery)
  • Onset with seizures, and the paralysis was suspected to be related to Todd paralysis.
  • Administration of heparin within 48 hours preceding the onset of stroke with a baseline APTT exceeding the upper limit of the normal range.
  • Oral anticoagulant (such as warfarin) treatment with baseline INR>1.7 or PT>15 s;
Show all 22Show fewer
  • Administration of thrombin inhibitors or factor Xa inhibitors within 48 hours preceding the onset of stroke with abnormal coagulation parameters or platelet count;
  • BP couldn't be controlled with aggressive treatment. Uncontrolled hypertension was defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, measured for three times every 10 minutes.
  • Platelet count of less than 100×109/ L;
  • Blood glucose <50 mg/dl (<2.8 mmol/L) or >400 mg/dl (22.22 mmol/L);
  • History of intracranial hemorrhage or active hemorrhagic disease. (Such as gastrointestinal, urinary tract or retinal bleeding)
  • Tumors with an increased risk of bleeding.
  • Prolonged or traumatic cardiopulmonary resuscitation (>2 min), delivery within the last 10 days or recent puncture of non-compression vessels such as subclavian vein or jugular vein
  • Acute pancreatitis or severe liver disease, including liver failure, cirrhosis, portal hypertension, esophageal varicose veins, and active hepatitis;
  • Aortic arch dissection;
  • Major surgery or severe trauma in the past 2 weeks;
  • Subjects had serious, fatal, or disabling disease with an expected survival of less than 3 months;
  • Unable to complete neurological assessment and follow-up visits because of dementia or mental illness;
  • Pregnant women, lactating women, or have positive pregnancy test;
  • Allergy to tenecteplase or alteplase or their components;
  • Participation in other clinical trials within 3 months prior to screening;
  • Unsuitable to involve in this study or would result in increased risk, as judged by the investigators.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • Baogang Hospital of Inner Monglia

    Baotou, Inner Monglia, 014010

  • Inner Mongolia Baotou Hospital

    Baotou, Inner Mongolia, 014040

  • Beijing Tiantan Hospital, Capital Medical University Beijing

    Beijing, Beijing Municipality, 100000

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Changzhi People'S Hospital

    Changzhi, Shanxi, 046000

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163000

  • Dazhu County People's Hospital

    Dazhou, Sichuan, 635199

  • Zhejiang Provincial People'S Hospital

    Hangzhou, Zhejiang, 310000

  • Hengshui people's Hospital (Harrison International Peace Hospital)

    Hengshui, Hebei, 053000

  • Huai'an Second People's Hospital

    Huai'an, Jiangsu, 121000

  • Shandong Provincial Third Hospital

    Jinan, Shandong, 250000

  • The First People's Hospital of Jinzhong

    Jinzhong, Shanxi, 030602

  • Liaocheng People'S Hospital

    Liaocheng, Shandong, 252006

  • Linyi City People Hospital

    Linyi, Shandong, 276000

  • Mei He Kou Central Hospital

    Meihekou, Jilin, 135000

  • Qingdao Central Hospital

    Qingdao, Shandong, 266000

  • Quanzhou First Hospital

    Quanzhou, Fujian, 362000

  • Shanghai Pudong Hospital

    Shanghai, Shanghai Municipality, 201200

  • Yue Bei People'S Hospital

    Shaoguan, Guangdong, 512000

  • Jilin Guowen Hospital

    Siping, Jilin, 136100

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 318000

  • Tangshan Gongren Hospital

    Tangshan, Hebei, 063000

  • The Affiliated Hospital of Xuzhou Meidcal University

    Xuzhou, Jiangsu, 221006

  • Yantai Yuhangding Hospital

    Yantai, Shandong, 264000

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia, 750001

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • Zigong First People'S Hospital

    Zigong, Sichuan, 643000

Other trials in China

About this study

Official title: Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients: a Multi-center, Block Randomized, Positive Drug Parallel Controlled Phase II Trial

The trial is prospective, block randomized, open-label, blinded endpoint (PROBE) design. Patients with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be randomized 1:1:1 to 0.25mg/kg or 0.40mg/kg intravenous tenecteplase or 0.9 mg/kg alteplase before all participants undergo endovascular thrombectomy.

Read the detailed description

The study will be a multi-center, prospective, randomized, open- label, blinded endpoint (PROBE), controlled phase 2 trial (3 arm with 1:1:1 randomization) in ischemic stroke patients. Imagine is performed with CT or MRI acutely with imaging follow-up at 24-30 hours. The sample size is 225.

Being tested
Alteplase, Tenecteplase
Keywords
TNK-tPA, rt-PA, Acute stroke, phase II trial
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

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

  • AlteplaseDrug

    Also called rt-PA

    Alteplase 0.9mg/kg are being used.

  • TenecteplaseDrug

    Also called TNK-tPA

    Tenecteplase 0.25mg/kg are being used.

  • TenecteplaseDrug

    Also called TNK-tPA

    Tenecteplase 0.4mg/kg are being used.

Study groups in NCT05281549
Study groupRoleWhat they receive
AlteplaseActive comparatorPatients will receive intravenous Alteplase at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.
Receives: Drug: Alteplase
Tenecteplase 0.25mg/kgExperimentalPatients will receive intravenous Tenecteplase, 0.25mg/kg, maximum 25mg, administered as a bolus over 5~10 seconds
Receives: Drug: Tenecteplase
Tenecteplase 0.4mg/kgExperimentalPatients will receive intravenous Tenecteplase, 0.4mg/kg, maximum 40mg, administered as a bolus over 5~10 seconds
Receives: Drug: Tenecteplase

What is being measured

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

  1. Modified Rankin Scale(mRS)

    Proportion of subjects with mRS scores of (0-1) at 90±7 days.(Comments:The minimum and maximum values are from 0 to 6,and higher scores mean a worse outcome.)

    Measured: 90±7 days

Secondary outcomes (7)

  1. National Institutes of Health Stroke Scale (NIHSS)

    NIHSS score at 24±2 hours.(Comments:The minimum and maximum values are from 0 to 40, and higher scores mean a worse outcome.)

    Measured: 24±2 hours

  2. National Institutes of Health Stroke Scale (NIHSS)

    Proportion of subjects with ≥ 4 point reduction in NIHSS or reaching 0-1 at 7 ± 2 days or before discharge (whichever occurs first).(Comments:The minimum and maximum values are from 0 to 40, and higher scores mean a worse outcome.)

    Measured: 7±2days or discharge

  3. Modified Rankin Scale(mRS)

    Proportion of subjects with mRS scores of (0-2) at 90±7 days.(Comments:The minimum and maximum values are from 0 to 6,and higher scores mean a worse outcome.)

    Measured: 90±7 days

  4. Modified Rankin Scale(mRS)

    mRS scores at 90±7 days.(Comments:The minimum and maximum values are from 0 to 6,and higher scores mean a worse outcome.)

    Measured: 90±7 days

  5. The new vascular events

    Incidence of the new vascular events, ischemic stroke, hemorrhagic stroke, myocardial infarction and cardio-cerebral revascularization at 90±7 days. (including: carotid endarterectomy, intracranial and extracranial artery interventional therapy, intracranial and extracranial artery bypass surgery, coronary interventional or bypass therapy)

    Measured: 90±7 days

  6. Deaths

    Vascular mortality at 90±7 days (mainly due to stroke, myocardial infarction or pulmonary embolism)

    Measured: 90±7 days

  7. EQ-5D

    EQ-5D scores at 90±7 days.(Comments:The minimum and maximum values are from 0 to 100,and higher scores mean a better outcome.)

    Measured: 90±7 days

Timeline

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

  1. First posted16 Mar 2022
  2. Study start2 May 2021
  3. Primary completion28 Jan 2022
  4. Study completion31 May 2022 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
225 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05281549
Sponsor's protocol ID
PR-SMTJ-2019001F
Status last verified
Mar 2022
First submitted
7 Mar 2022
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haley EC Jr, Thompson JL, Grotta JC, Lyden PD, Hemmen TG, Brown DL, Fanale C, Libman R, Kwiatkowski TG, Llinas RH, Levine SR, Johnston KC, Buchsbaum R, Levy G, Levin B; Tenecteplase in Stroke Investigators. Phase IIB/III trial of tenecteplase in acute ischemic stroke: results of a prematurely terminated randomized clinical trial. Stroke. 2010 Apr;41(4):707-11. doi: 10.1161/STROKEAHA.109.572040. Epub 2010 Feb 25.

    PubMed 20185783

  • Guidelines Editing Group of Chinese Stroke Society, Guidelines for the Diagnosis and Treatment of High-risk Non-Disabling Ischemic Cerebrovascular Events, Chinese Journal of Stroke, June 2016, 11 (6), p481-491.

  • Chinese Journal of Circulation, China Cardiovascular Disease Report 2015.

  • CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. CAST (Chinese Acute Stroke Trial) Collaborative Group. Lancet. 1997 Jun 7;349(9066):1641-9.

    PubMed 9186381

  • Hao Zilong, Liu Ming, Li Wei, et al. Stroke registration method and basic characteristics and functional outcomes of 3123 patients in Chengdu [J]. Chinese Journal of Neurology, 2011,12 (44) : 826-831.

  • Wang Z, Li J, Wang C, Yao X, Zhao X, Wang Y, Li H, Liu G, Wang A, Wang Y. Gender differences in 1-year clinical characteristics and outcomes after stroke: results from the China National Stroke Registry. PLoS One. 2013;8(2):e56459. doi: 10.1371/journal.pone.0056459. Epub 2013 Feb 13.

    PubMed 23418571

  • Wei JW, Heeley EL, Wang JG, Huang Y, Wong LK, Li Z, Heritier S, Arima H, Anderson CS; ChinaQUEST Investigators. Comparison of recovery patterns and prognostic indicators for ischemic and hemorrhagic stroke in China: the ChinaQUEST (QUality Evaluation of Stroke Care and Treatment) Registry study. Stroke. 2010 Sep;41(9):1877-83. doi: 10.1161/STROKEAHA.110.586909. Epub 2010 Jul 22.

    PubMed 20651267

  • Bandera E, Botteri M, Minelli C, Sutton A, Abrams KR, Latronico N. Cerebral blood flow threshold of ischemic penumbra and infarct core in acute ischemic stroke: a systematic review. Stroke. 2006 May;37(5):1334-9. doi: 10.1161/01.STR.0000217418.29609.22. Epub 2006 Mar 30.

    PubMed 16574919

  • Donnan GA, Baron JC, Ma H, Davis SM. Penumbral selection of patients for trials of acute stroke therapy. Lancet Neurol. 2009 Mar;8(3):261-9. doi: 10.1016/S1474-4422(09)70041-9.

    PubMed 19233036

  • Parsons M, Spratt N, Bivard A, Campbell B, Chung K, Miteff F, O'Brien B, Bladin C, McElduff P, Allen C, Bateman G, Donnan G, Davis S, Levi C. A randomized trial of tenecteplase versus alteplase for acute ischemic stroke. N Engl J Med. 2012 Mar 22;366(12):1099-107. doi: 10.1056/NEJMoa1109842.

    PubMed 22435369

  • Huang X, Cheripelli BK, Lloyd SM, Kalladka D, Moreton FC, Siddiqui A, Ford I, Muir KW. Alteplase versus tenecteplase for thrombolysis after ischaemic stroke (ATTEST): a phase 2, randomised, open-label, blinded endpoint study. Lancet Neurol. 2015 Apr;14(4):368-76. doi: 10.1016/S1474-4422(15)70017-7. Epub 2015 Feb 26.

    PubMed 25726502

  • Logallo N, Novotny V, Assmus J, Kvistad CE, Alteheld L, Ronning OM, Thommessen B, Amthor KF, Ihle-Hansen H, Kurz M, Tobro H, Kaur K, Stankiewicz M, Carlsson M, Morsund A, Idicula T, Aamodt AH, Lund C, Naess H, Waje-Andreassen U, Thomassen L. Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial. Lancet Neurol. 2017 Oct;16(10):781-788. doi: 10.1016/S1474-4422(17)30253-3. Epub 2017 Aug 2.

    PubMed 28780236

  • Campbell BCV, Mitchell PJ, Churilov L, Yassi N, Kleinig TJ, Dowling RJ, Yan B, Bush SJ, Dewey HM, Thijs V, Scroop R, Simpson M, Brooks M, Asadi H, Wu TY, Shah DG, Wijeratne T, Ang T, Miteff F, Levi CR, Rodrigues E, Zhao H, Salvaris P, Garcia-Esperon C, Bailey P, Rice H, de Villiers L, Brown H, Redmond K, Leggett D, Fink JN, Collecutt W, Wong AA, Muller C, Coulthard A, Mitchell K, Clouston J, Mahady K, Field D, Ma H, Phan TG, Chong W, Chandra RV, Slater LA, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Bladin CF, Sharma G, Desmond PM, Parsons MW, Donnan GA, Davis SM; EXTEND-IA TNK Investigators. Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke. N Engl J Med. 2018 Apr 26;378(17):1573-1582. doi: 10.1056/NEJMoa1716405.

    PubMed 29694815

  • Standards and procedures for rapid reporting of safety data during drug clinical trials

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alteplase and Tenecteplase in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 28 sites in China.

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 5 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 31 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 28 sites in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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?

Modified Rankin Scale(mRS) (time frame: 90±7 days). 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 NCT05281549, which also lists 14 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 31 Mar 2022.

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