Study of Tiprogrel in the Treatment of High-risk Patients with Acute Ischemic Cerebrovascular Events (THRIVE).
NCT ID: NCT06601127
Last Updated: 2025-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
600 participants
INTERVENTIONAL
2025-02-21
2026-06-01
Brief Summary
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Detailed Description
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Patients in Low-dose Tiprogrel group and High-dose Tiprogrel group will accept long term dual antiplatelet therapy (DAPT) (Aspirin and Tiprogrel for 90 days) . Patients in Clopidogrel group will accept dual antiplatelet therapy (DAPT) (Aspirin and Tiprogrel for 21 days followed by Clopidogrel on days 22 to 90) .
The primary endpoint is Percent of participants with ischemic stroke on the 90th day after treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low-dose Tiprogrel group
Drug: Tiprogrel and Aspirin Day 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin.
Tiprogrel
Day 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin.
High-dose Tiprogrel group
Drug: Tiprogrel and Aspirin Day 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin.
Tiprogrel
Drug: Tiprogrel and Aspirin Day 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin.
Clopidogrel group
Drug: Clopidogrel and Aspirin Day 1, loading dose of Clopidogrel and loading dose of aspirin; Day 2-21, daily maintenance dose of Clopidogrel and daily maintenance dose of aspirin; D22-90: daily maintenance dose of Clopidogrel.
Clopidogrel
Day 1, loading dose of Clopidogrel and loading dose of aspirin; Day 2-21, daily maintenance dose of Clopidogrel and daily maintenance dose of aspirin; D22-90: daily maintenance dose of Clopidogrel.
Interventions
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Tiprogrel
Day 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin.
Tiprogrel
Drug: Tiprogrel and Aspirin Day 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin.
Clopidogrel
Day 1, loading dose of Clopidogrel and loading dose of aspirin; Day 2-21, daily maintenance dose of Clopidogrel and daily maintenance dose of aspirin; D22-90: daily maintenance dose of Clopidogrel.
Eligibility Criteria
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Inclusion Criteria
2. Acute Minor Ischaemic Stroke：AIS is defined as acute onset of neurological deficit attributed to focal brain ischaemia, NIHSS ≤5, and either of the following imaging characteristics:
1. Acute single infarction with ≥50% stenosis of a major intracranial or extracranial artery.
2. Acute multiple infarctions attributed to large-artery atherosclerosis, including non-stenotic vulnerable plaques.
TIA with high risk of stroke: ABCD2 score ≥ 6 at the time of randomization, and the following imaging characteristic:
Exclusion Criteria
2. Isolated or pure sensory symptoms, isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI.
3. Preceding mRS\> 2
4. Contraindication to anti-platelet therapy
5. Clear indication for anticoagulation
6. Two or more antiplatelet drugs have been used continuously for ≥3 days before enrollment.
7. Used heparin or oral anticoagulant drugs within 10 days before enrollment
8. Undergone intravenous or arterial thrombolysis and mechanical thrombectomy within 24 hours before enrollment
9. History of intracranial hemorrhage or amyloid angiopathy
10. History of aneurysm
11. Diagnosis or suspicious diagnosis of acute coronary syndrome
12. History of asthma
13. High-risk for bradyarrhythmia
14. Anticipated requirement for long-term (\>5 days) non-steroidal anti-inflammatory drugs or NSAIDs within the 8th day of randomization
15. History of gastrointestinal bleeding within 3 months before enrollment or major surgery within 30 days
16. Iatrogenic causes of minor stroke or TIA
17. Planned or likely revascularization within the next 3 months, scheduled for surgery or interventional treatment requiring study drug cessation
18. Severe non-cardiovascular comorbidity with life expectancy \< 3 months
19. Women of childbearing age who have not taken effective contraceptive measures and have a positive pregnancy test record, as well as women who are pregnant or breastfeeding
20. Currently receiving an experimental drug or device
21. Participation in another clinical study with an experimental product during the last 30 days
22. Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders
23. Hemoglobin \<90g/L %
24. Permanent hypertension
25. Subjects who were judged by the investigator to be unsuitable for this clinical study
40 Years
ALL
No
Sponsors
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Tianjin Institute of Pharmaceutical Research Co., Ltd
OTHER_GOV
Responsible Party
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Locations
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Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, China
Beijing Tiantan Hosptial, Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TY601A-P2-01
Identifier Type: -
Identifier Source: org_study_id
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