This study is designed to evaluate efficacy and safety of tiprogrel in the treatment of patients with acute ischemic cerebrovascular events.
To evaluate the safety and efficacy of Tiprogrel at different doses within 24 hours after symptom onset in Patients with Acute Minor Ischaemic Stroke or High-risk Transient Ischaemic Attack. Patients wil be enrolled and randomized to Low-dose Tiprogrel, High-dose Tiprogrel and Clopidogrel group in a 1:1:1 ratio. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
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.
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.
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.
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, China
RECRUITINGBeijing Tiantan Hosptial, Capital Medical University
Beijing, China
NOT_YET_RECRUITINGPercent of participants with ischemic stroke
Participants with ischemic stroke
Time frame: on the 90th day after treatment
Percent of participants with ischemic Stroke
Participants with ischemic stroke
Time frame: on the 21th day after treatment
Percent of participants with serve composite ischemic events: nonfatal ischemic strokes, nonfatal myocardial infarction or death from ischemic vascular causes
Participants with serve composite ischemic events
Time frame: on the 21th and 90th day after treatment
Percent of participants with nonfatal ischemic strokes
Participants with nonfatal ischemic strokes
Time frame: on the 21th and 90th day after treatment
Percent of participants with nonfatal myocardial infarction
Participants with nonfatal myocardial infarction
Time frame: on the 21th and 90th day after treatment
Percent of participants with death from ischemic vascular events
Participants with death from ischemic vascular events
Time frame: on the 21th and 90th day after treatment
Percent of participants with ischemic vascular events
Participants with ischemic vascular events
Time frame: on the 21th and 90th day after treatment
Percent of participants with stroke (ischemic or hemorrhagic)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants with stroke (ischemic or hemorrhagic)
Time frame: on the 21th and 90th day after treatment
Percent of participants with cardiovascular death
Participants with cardiovascular death
Time frame: on the 21th and 90th day after treatment
Scores on the modified Rankin scale range
Scores on the modified Rankin scale range"
Time frame: on the 90th day after treatment