Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis

Phase 4

Not yet recruiting

• Conditions: Ischemic Stroke; Intracranial Arteriosclerosis; Secondary Prevention; Antiplatelet Drug
• Interventions: Drug: clopidogrel for 90 days combined with aspirin for 90 days; Drug: clopidogrel for 30 days combined with aspirin for 90 days

• Registration Number: NCT06243133
• Lead Sponsor: Sichuan Provincial People's Hospital

Brief Summary

The goal of this clinical trial is to learn about efficacy and safety of dual antiplatelet therapy in ischemic stroke with intracranial artery stenosis. The main question it aims to answer are:

whether aspirin combined with clopidogrel for 3 month is better than 1 months for patients with non-cardiogenic cerebral infarction with intracranial artery stenosis.

Participants will get dual antiplatelet therapy (aspirin plus clopidogrel) for 1 month or 3 months within 7 days of the first stroke.

Researchers will compare experimental group (3 months dual antiplatelet therapy) with comparison group (1 month dual antiplatelet therapy), to see if experimental group would reduce stroke recurrence or mortality, and increase bleeding and other adverse prognosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-28
• Study First Submitted QC: 2024-01-28
• Study First Posted: 2024-02-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Study Start: 2024-07-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

1. Age 40 ~ 80 years old;
2. Patients diagnosed as non-cardiogenic cerebral infarction according to the WHO definition of stroke, with MRA/CTA/DSA confirmed intracranial artery stenosis ≥50% (intracranial carotid artery, M1 and proximal M2 segment of middle cerebral artery, A1 and A2 segment of anterior cerebral artery, P1 and P2 segment of posterior cerebral artery, intracranial vertebral artery and basilar artery);
3. First stroke onset within 7 days;
4. NIHSS score ≤5;
5. Patients or family members sign informed consent forms;

Exclusion Criteria

1. Patients receiving thrombolysis or endovascular therapy;
2. Patients with recurrent stroke;
3. Patients has undergone major surgery or major trauma within the past 30 days;
4. History of gastrointestinal bleeding, active peptic ulcer, intracranial hemorrhage or other hemorrhagic diseases;
5. Contraindications or intolerances to the use of antiplatelet therapeutics;
6. Platelet count <100*109/L, hemoglobin<110g/L;
7. Patients with severe organ insufficiency or other serious disease (e.g., severe cardiopulmonary failure, advanced tumor, severe dementia);
8. Patients intolerant to MRI scan are replaced by CT or DSA;
9. poor compliance, unable to meet the requirements of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual antiplatelet therapy for 90 days	clopidogrel for 90 days combined with aspirin for 90 days	Clopidogrel 300mg on the first day, then 75mg/day for 90 consecutive days; Aspirin 100mg/day for 90 days
Dual antiplatelet therapy for 30 days	clopidogrel for 30 days combined with aspirin for 90 days	Clopidogrel 300mg on the first day, then 75mg/ day for 30 consecutive days; Aspirin 100mg/ day for 90 days

Primary Outcome Measures

Name	Time	Method
3-month major ischemic events and major bleeding events	3-month	Including any of the following: Cardiovascular and cerebrovascular mortality, Incidence of stroke (including ischemic and hemorrhagic), Incidence of myocardial infarction, bleeding events classified by BARC (Bleeding Academic Research Consortium) criteria

Secondary Outcome Measures

Name	Time	Method
disability	3-month	mRS(Modified Rankin Scale)\>2
Cardiovascular or cerebrovascular mortality	3-month	mortality of Cardiovascular or cerebrovascular disease

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China