Protocol for a Randomized Controlled Trial of Platelet Aggregation Function Guiding Precise Antiplatelet Therapy for...

Area of Science:

• Neurology
• Cardiology
• Pharmacology

Background:

• High on-treatment platelet reactivity (HOPR) on aspirin is common in ischemic stroke patients.
• HOPR is linked to 'aspirin resistance' and higher risk of recurrent vascular events.
• Individualized antiplatelet therapy guided by platelet function tests may enhance stroke prevention.

Purpose of the Study:

• To evaluate a platelet function-guided precision antiplatelet therapy strategy.
• To compare guided therapy against standard aspirin monotherapy in non-cardioembolic ischemic stroke.
• To assess the primary outcome of HOPR at 30 days post-randomization.

Main Methods:

• The PATH STROKE trial is a multicenter, prospective, randomized, controlled, open-label, blinded-endpoint (PROBE) study.
• 1018 patients with recent ischemic stroke on aspirin were randomized 1:1 to guided therapy or standard care.
• Guided therapy adjusted antiplatelet agents (clopidogrel, ticagrelor) for patients with HOPR (≥35% max aggregation rate).

Main Results:

• The primary outcome was the rate of HOPR at 30±5 days.
• Secondary outcomes included major ischemic events, stroke occurrence (ischemic/hemorrhagic), quality of life, and bleeding events (BARC criteria).

Conclusions:

• PATH STROKE is the first clinical trial assessing a precision-medicine strategy guided by platelet function for secondary stroke prevention.
• This approach aims to optimize antiplatelet treatment effectiveness and reduce recurrent ischemic events.