Clinical trial NCT06243133: Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis
Official title: Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Ischemic Stroke
Intracranial Arteriosclerosis
Secondary Prevention
Antiplatelet Drug
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 1100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 3-month major ischemic events and major bleeding events
timeFrame: 3-month
Secondary outcomes:
measure: disability
timeFrame: 3-month
measure: Cardiovascular or cerebrovascular mortality
timeFrame: 3-month
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: Nengwei Yu, master
role: STUDY_CHAIR
affiliation: Sichuan Provincial People's Hospital
name: Jie Yang, doctor
role: STUDY_CHAIR
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