Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis (PATH-ICAS)

Sichuan Provincial People's Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Ischemic Stroke; Antiplatelet Drug; Secondary Prevention; Intracranial Arteriosclerosis

Treatments: Drug: clopidogrel for 90 days combined with aspirin for 90 days; Drug: clopidogrel for 30 days combined with aspirin for 90 days

Study type: Interventional

Funder types: Other

Identifiers

NCT06243133

20223972

Details and patient eligibility

About

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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,100 participants in 2 patient groups

Dual antiplatelet therapy for 30 days

Experimental group

Description:

Clopidogrel 300mg on the first day, then 75mg/ day for 30 consecutive days; Aspirin 100mg/ day for 90 days

Treatment:

Drug: clopidogrel for 30 days combined with aspirin for 90 days

Dual antiplatelet therapy for 90 days

Active Comparator group

Description:

Clopidogrel 300mg on the first day, then 75mg/day for 90 consecutive days; Aspirin 100mg/day for 90 days

Treatment:

Drug: clopidogrel for 90 days combined with aspirin for 90 days