Cilostazol Stroke Prevention Study for Antiplatelet Combination "CSPS・com"


Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- Patients with a diagnosis of noncardioembolic IS that developed between 8 and 180 days before the start of the protocol treatment
- Patients with a responsible lesion identified by MRI
- Patients aged 20 to 85 years old when providing informed consent
- Patients taking clopidogrel or aspirin alone as antiplatelet therapy when providing informed consent
- Patients meeting at least one of the following criteria a−c:
1. at least 50% stenosis of a major intracranial artery (to the level of A2, M2, or P2)
2. at least 50% stenosis of an extracranial artery (the common carotid artery,internal carotid artery,vertebral artery,brachiocephalic artery,or subclavian artery)
3. Two or more of the following risk factors
- Aged 65 years or more
- Diabetes mellitus
- Hypertension
- Peripheral arterial disease
- Chronic kidney disease
- History of IS (excluding the index IS for this study)
- History of ischemic heart disease
- Smoking (only current smokers)
- Patients considered to be able to visit the study site for ambulatory care throughout the observation period
- Patients who provided written informed consent

Exclusion Criteria

- Patients with emboligenic heart disease
- Patients taking any anticoagulant agents
- Patients who cannot undergo MRI examination for reasons such as claustrophobia and implanted pacemaker
- Patients scheduled to undergo any surgery, such as percutaneous angioplasty, stent placement, and bypass grafting, during the study period
- Patients with a drug-eluting coronary stent implanted within one year
- Patients with a history of symptomatic non-traumatic intracranial hemorrhage, any other hemorrhagic disease (eg, active peptic ulcer), bleeding predisposition, or blood clotting disorders
- Patients with a history of hypersensitivity to cilostazol
- Patients with congestive heart failure or uncontrolled angina pectoris
- Patients with thrombocytopenia (platelet count ≦ 100,000/mm3)
- Patients with severe liver or renal dysfunction
- Women who are pregnant, breast-feeding, or of child-bearing potential
- Patients with a malignant tumor requiring treatment
- Patients who are taking aspirin, and meet any of the following criteria:
- History of hypersensitivity to aspirin or salicylic acid analogues
- Current peptic ulcer
- Aspirin-induced asthma or its history
- Patients who are taking clopidogrel, and meet the following criterion:
・History of hypersensitivity to clopidogrel
- Patients who are participating in any other clinical studies
- Patients considered by the investigator/subinvestigator to be unsuitable for participating in this study