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Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis

ConditionsIschemic StrokeIntracranial ArteriosclerosisSecondary PreventionAntiplatelet Drug
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-80
SponsorSichuan Provincial People's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age 40 ~ 80 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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • clopidogrel for 90 days combined with aspirin for 90 days

    Drug

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

  • clopidogrel for 30 days combined with aspirin for 90 days

    Drug

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

Treatment groups

1,100 Participants
are divided into 2 treatment groups
Group A: Dual antiplatelet therapy for 30 daysExperimental treatment 1 intervention
Group B: Dual antiplatelet therapy for 90 daysActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

3-month major ischemic events and major bleeding events

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

Time frame
3-month

Secondary outcomes

1

disability

mRS(Modified Rankin Scale)\>2

Time frame
3-month
2

Cardiovascular or cerebrovascular mortality

mortality of Cardiovascular or cerebrovascular disease

Time frame
3-month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: