Noncardioembolic Cerebral Infarction Clinical Trial
— CSPS·comOfficial title:
Cilostazol Stroke Prevention Study for Antiplatelet Combination
| Verified date | March 2019 |
| Source | Japan Cardiovascular Research Foundation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for secondary prevention of ischemic stroke in high-risk patients for stroke
| Status | Completed |
| Enrollment | 1884 |
| Est. completion date | December 7, 2018 |
| Est. primary completion date | December 7, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 85 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Japan Cardiovascular Research Foundation | Osaka |
| Lead Sponsor | Collaborator |
|---|---|
| Japan Cardiovascular Research Foundation | Otsuka Pharmaceutical Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours | An "ischemic stroke" hereafter indicates a symptomatic ischemic stroke. | every 6 months | |
| Secondary | Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)] | every 6 months | ||
| Secondary | SAH or ICH | every 6 months | ||
| Secondary | IS or transient ischemic attack (TIA) | every 6 months | ||
| Secondary | Death from any cause | every 6 months | ||
| Secondary | Stroke (IS,ICH,SAH), myocardial infarction (MI), or vascular death | every 6 months | ||
| Secondary | All vascular events: stroke, MI, and other vascular events | every 6 months | ||
| Secondary | Adverse events and adverse drug reactions | every 6 months | ||
| Secondary | Severe or life-threatening hemorrhage (GUSTO Criteria) | every 6 months |