Guided antiplatelet therapy for patients with ischemic stroke

Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Ischemic STROKE

This study tests if a personalized approach to antiplatelet therapy can help stroke patients respond better to treatment and reduce the risk of having another stroke.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1020 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sichuan Provincial People's Hospital (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06269432 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of personalized antiplatelet therapy based on platelet aggregation function in patients suffering from non-cardiogenic ischemic stroke. It focuses on reducing the incidence of high on-treatment platelet reactivity (HOPR) within 30 days of treatment. Participants will be divided into two groups: one receiving precision-guided therapy and the other receiving traditional antiplatelet therapy. The study seeks to address the challenge of aspirin and clopidogrel resistance, which affects a significant number of stroke patients and can lead to recurrent strokes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have experienced a non-cardiogenic ischemic stroke within the last three months and are currently on antiplatelet therapy.

Not a fit: Patients with a history of recurrent strokes or those with severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of recurrent strokes in patients by optimizing antiplatelet therapy.

How similar studies have performed: While the approach of using platelet aggregation function to guide therapy is promising, it is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

1. Aged from 18 to 80 years;
2. Diagnosed with non-cardiogenic ischemic stroke according to WHO criteria, confirmed by cranial CT or MRI to exclude hemorrhagic stroke.;
3. First stroke onset ≥ 1 month and ≤ 3 months;
4. mRS Score \<=2 points;
5. Undergoing antiplatelet therapy with 100mg aspirin daily for at least 8 days;
6. Informed consent signed by the patient or their family member.

Exclusion Criteria:

1. History of recurrent stroke.
2. History of gastrointestinal bleeding, intracranial hemorrhage, or other bleeding disorders.
3. Contraindications or intolerance to antiplatelet therapy medications.
4. Severe cardiac, pulmonary, hepatic, or renal insufficiency, or presence of severe comorbid conditions (e.g., end-stage malignant tumors, severe single/multiple organ failure).
5. Poor compliance, inability to cooperate with study requirements.

Where this trial is running

Chengdu, Sichuan

• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Jie Yang, doctor

Conditions Ischemic Stroke; Antiplatelet Drug