Protocol for Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com): a randomized, open-label,...

Area of Science:

• Neurology
• Cardiology
• Clinical Trials

Background:

• Monotherapy with antiplatelet agents offers limited efficacy in secondary ischemic stroke (IS) prevention, especially in high-risk individuals.
• Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel reduces IS recurrence but increases bleeding risk.
• Cilostazol monotherapy showed efficacy in preventing IS recurrence without increasing bleeding, and DAPT with cilostazol and aspirin did not significantly increase bleeding in patients with intracranial arterial stenosis.

Purpose of the Study:

• To evaluate the safety and efficacy of DAPT involving cilostazol for secondary IS prevention.
• To compare DAPT with cilostazol against antiplatelet monotherapy in high-risk IS patients.
• To assess the potential of cilostazol-based DAPT to improve outcomes in secondary IS prevention.

Main Methods:

• The Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com) is a multicenter, randomized, open-label trial.
• 4000 high-risk patients with noncardioembolic IS will be randomized.
• Treatment arms include aspirin monotherapy, clopidogrel monotherapy, or DAPT with cilostazol and aspirin or clopidogrel for at least one year.

Main Results:

• The primary outcome is the recurrence of IS.
• Secondary outcomes include composite events of stroke, all-cause mortality, myocardial infarction, vascular death, and other vascular events.

Conclusions:

• The CSPS.com trial is expected to determine if DAPT involving cilostazol enhances secondary IS prevention in high-risk populations.
• Findings will inform clinical practice regarding the use of cilostazol in DAPT regimens for stroke prevention.