Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis

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Description

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.

Study Overview

Start Date
January 25, 2024
Completion Date
March 31, 2026
Enrollment
1100
Date Posted
February 6, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China

Eligibility

Minimum Age (years)
40
Maximum Age (years)
75
Eligibility Criteria
Inclusion Criteria:

Age 40 ~ 75 years old;
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);
First stroke onset within 7 days;
NIHSS score ≤5;
Patients or family members sign informed consent forms;

Exclusion Criteria:

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

Study Contact Info

Study Contact Name
Jie Yang, doctor; Jiang Guo, doctor
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06243133