Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
NCT Number: NCT07644234
This multicenter, prospective, open-label, randomized controlled trial will evaluate whether platelet aggregation function-guided de-escalation of antiplatelet therapy is non-inferior in efficacy and superior in safety compared with standard dual antiplatelet therapy in patients with acute minor ischemic stroke or high-risk transient ischemic attack who are sensitive to clopidogrel.
Participants who present within 48 hours of symptom onset and meet the eligibility criteria will receive loading doses of clopidogrel and aspirin, followed by platelet aggregation function testing. Eligible clopidogrel-sensitive participants will be randomized to receive either 7 days of dual antiplatelet therapy followed by clopidogrel monotherapy or standard 21-day dual antiplatelet therapy followed by single antiplatelet therapy. The primary efficacy outcome is new stroke within 90 days after randomization.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Chengdu, Sichuan, 610072, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
3.Symptom onset within 48 hours. Onset time is defined as the interval from the last time the participant was known to be well to the time of combined administration of clopidogrel 300 mg and aspirin 100 mg.
4.MARADP <35% measured 5 to 20 hours after combined antiplatelet treatment with clopidogrel 300 mg and aspirin 100 mg within 48 hours of symptom onset.
5.Planned treatment with aspirin plus clopidogrel or clopidogrel monotherapy for antiplatelet therapy.
6.Written informed consent provided by the participant or a legally authorized representative.
Exclusion criteria
1.Imaging evidence of hemorrhagic stroke, hemorrhagic transformation, or another pathological brain disorder, such as vascular malformation, tumor, abscess, or another common non-ischemic brain disease such as multiple sclerosis.
2.Minor stroke or transient ischemic attack caused by angioplasty or vascular surgery.
3.Atrial fibrillation indicated by standard electrocardiography or typical physical signs of atrial fibrillation, including absolutely irregular rhythm, variable intensity of the first heart sound, or pulse deficit.
4.A clear indication for anticoagulation, including suspected cardioembolism such as atrial fibrillation, known artificial heart valve, or suspected endocarditis.
5.Intravenous thrombolysis, intra-arterial thrombolysis, mechanical thrombectomy, or any revascularization procedure performed after the index event or planned within 90 days.
6.Use of antiplatelet agents other than aspirin or clopidogrel within 7 days before enrollment, such as ticagrelor or prasugrel.
7.History of gastrointestinal bleeding, intracranial hemorrhage, recent major bleeding or blood transfusion, excluding minor hemoptysis or minor abnormal vaginal bleeding, or other bleeding disorder caused by coagulation dysfunction, such as purpura.
8.Contraindication or intolerance to clopidogrel or aspirin, including known allergy; severe hepatic insufficiency or renal insufficiency; severe heart failure; coagulation disorder or history of systemic bleeding; history of thrombocytopenia or neutropenia; or history of drug-induced hematologic disease or hepatic dysfunction.
9.Leukopenia, defined as white blood cell count <2 x 10^9/L, or thrombocytopenia, defined as platelet count <100 x 10^9/L.
10.Use of heparin or oral anticoagulants within 10 days before enrollment. 11.Severe cardiac, pulmonary, hepatic, or renal dysfunction, or severe comorbid disease such as tumor, chronic airflow disease, severe dementia, or severe heart failure.
12.Female participants of childbearing potential with a negative pregnancy test who refuse to use effective contraception, or women who are pregnant or breastfeeding.
13.Poor compliance or inability to complete study requirements.
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Clopidogrel will be administered according to the assigned antiplatelet strategy. Participants receive a loading dose during screening and then clopidogrel 75 mg orally once daily during the assigned treatment period.
Aspirin will be administered according to the assigned antiplatelet strategy. Participants receive aspirin during screening and then aspirin 100 mg orally once daily during the assigned treatment period.
Time frame: within 90 days
Time frame: At Day 7 or hospital discharge, Day 30 and 1 year after randomization
Time frame: At Day 7 or hospital discharge, Day 30, Day 90, and 1 year after randomization
Including cardiovascular and cerebrovascular strokes, myocardial infarctions, and vascular deaths.
Time frame: At Day 30, Day 90, 1 year, and 2 years after randomization
The score range of the scale is from 0 to 6. The higher the score, the worse the outcome.
Time frame: At Day 7 or hospital discharge, Day 30, Day 90, and 1 year after randomization
Time frame: At 24 hours and at Day 7 or hospital discharge after randomization
Time frame: At Day 90 after randomization
It is usually represented by a value between 0 and 1, where 1 represents perfect health, 0 represents death, and the intermediate values reflect different degrees of health status.
Contact information is provided by the study sponsor or research team.
Sichuan Provincial People's Hospital
Other
Acronym: PATH STROKE D
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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