Cilostazol for Prevention of Recurrent Stroke Trial

Prior treatment

• Use of prohibited medication (as specified in the MOP)
• Confirmed diagnosis of heart failure with current or prior symptoms or signs (e.g. paroxysmal nocturnal dyspnea, reduced exercise tolerance, ankle swelling, elevated jugular venous pressure)

Other illness

• Atrial fibrillation, mechanical heart valve, or left ventricular assist device
• Planned cardiac surgery, percutaneous coronary intervention, carotid endarterectomy or stenting (patients are eligible post-procedure)
• History of symptomatic non-traumatic intracerebral hemorrhage within last 2 years
• Severe liver dysfunction (active hepatitis or hepatic insufficiency with Child-Pugh score B or C)
• Hypersensitivity to cilostazol or any component of the formulation (e.g. anaphylaxis, angioedema)
• Participants who are incarcerated, including prisoners or participants compulsorily detained for treatment of psychiatric disease.

Lab values

• Known thrombocytopenia (platelet count ≤100,000 per microliter (µL))

Other

• Modified Rankin Scale 5
• Pregnant, breast-feeding, or of child-bearing potential but not on birth control
• Currently enrolled in an investigational intervention study
• Life expectancy less than 6 months
• Participant does not allow contacting of their surrogate (e.g. family member or friend) or health care practitioner to obtain health information should participant become unwilling or unable to follow the study schedule.

• ≥40 years
• Ischemic stroke or high-risk TIA (ABCD2 score ≥6)
• Can be randomized within 180 days after ischemic stroke or high-risk TIA
• Treatment with single or dual antithrombotic therapy with aspirin, clopidogrel and/or ticagrelor per international and/or national guidelines
• Two or more of the following risk factors: age 65 years or older, hypertension, diabetes mellitus, history of ischemic stroke other than the qualifying event for this trial, currently smoking, peripheral arterial disease, coronary artery disease including prior MI, aortic atherosclerotic plaque ≥4 mm, ≥50% stenosis or occlusion of a major intracranial artery (ICA, M1, M2, A1, P1, vertebral, or basilar) or extracranial artery (ICA or vertebral)
• In the opinion of the site investigator, patient is medically stable, capable of participating in the trial, and willing and able to attend follow-up
• Able to receive study drug by mail and able to begin taking study drug promptly after receipt
• Provision of signed and dated informed consent form by patient or legally authorized representative