Noncardioembolic Cerebral Infarction
Conditions
Keywords
Noncardioembolic cerebral infarction, Dual antiplatelet therapy (DAPT), Cilostazol, Aspirin, Clopidogrel
Brief summary
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
Interventions
DRUGaspirin
Aspirin (81mg or 100mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
DRUGclopidogrel
Clopidogrel (50mg or 75mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
DRUGcilostazol
Cilostazol (100mg twice daily) will be orally administered. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Japan Cardiovascular Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours | every 6 months | An ischemic stroke hereafter indicates a symptomatic ischemic stroke. |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and adverse drug reactions | every 6 months |
| Severe or life-threatening hemorrhage (GUSTO Criteria) | every 6 months |
| Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)] | every 6 months |
| All vascular events: stroke, MI, and other vascular events | every 6 months |
| IS or transient ischemic attack (TIA) | every 6 months |
| Death from any cause | every 6 months |
| Stroke (IS，ICH，SAH), myocardial infarction (MI), or vascular death | every 6 months |
| SAH or ICH | every 6 months |
Countries
Japan
Outcome results
None listed