NCT00311402已完成3 期
JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme, Phase III Study to Compare the Preventive Effect of Recurrent Brain Infarction and Safety of Aggrenox (Combination Drug Containing Sustained-release Dipyridamole 200 mg/Acetylsalicylic Acid 25 mg) Twice Daily vs. Acetylsalicylic Acid 81 mg Once Daily
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,295
- 试验地点
- 151
- 主要终点
- Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)
研究概览
简要总结
Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Prevention
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of cerebral infarction (excluding cardiogenic cerebral embolism) who meet the diagnostic criteria based on the National Institute of Neurological Disorders and Stroke (NINDS) ad hoc committee's classification of cerebrovascular disease III.
- •Patients who have had an onset of cerebral infarction, the time of which is known, between 1 week and 6 months before the time of enrolment (including first and recurrent cerebral infarctions)
- •Patients who are 50 years or older
- •Patients whose neurological signs and symptoms are considered to be stable by the investigator or sub-investigator
- •Patients with a finding corresponding to the responsible focus confirmed by head X-ray computerised tomography (CT) or magnetic resonance imaging (MRI)
- •Patients who have at least two of the following risk factors:
- •hypertension (systolic blood pressure is 140 mmHg or higher or diastolic blood pressure is 90 mmHg or higher) or under treatment of hypertension
- •smoker (at the time of onset of cerebral infarction)
- •obesity (Body mass index (BMI) is more than 25 kg/m2)
- •previous vascular disease (stroke, acute myocardial infarction or peripheral arterial disease before the onset of cerebral infarction)
- •end-organ damage (retinopathy, left ventricular hypertrophy (LVH) or microalbuminuria)
- •hyperlipidaemia
排除标准
- •Patients with a diagnosis of brain disorders with a bleeding risk such as brain haemorrhage, subarachnoid haemorrhage, cerebral arteriovenous (AV) malformation, cerebral AV aneurysms and brain tumours
- •Patients with complications of cardiac disorders (atrial fibrillation, mitral valve stenosis, severe cardiac valve disorders) that may provide an embolic source for cerebral embolism
- •Patients having had acute coronary syndromes (acute myocardial infarction, unstable angina) within 6 months after enrolment in this study
- •Patient with hypersensitivity to dipyridamole preparations
- •Patients with a history of drug allergy to acetylsalicylic acid (ASA) or aspirin asthma
- •Patients with a history of peptic ulcer
- •Patients having undergone arterial reconstruction after development of cerebral infarction
- •Patients with very severe impairment (4 or 5 on Modified Rankin Scale)
- •Patients with bleeding or bleeding tendencies (haemophilia, haemorrhage urinary tract, vitreous haemorrhage, etc.)
- •Patients with severe hypertension (systolic blood pressure is 180 mmHg or higher or diastolic blood pressure is 110 mmHg or higher)
- •Patients with complications such as serious cardiac, renal and hepatic disorders
- •Patients with a malignant tumour or having had a tumour treatment in the past 5 years
- •Women who are or may be pregnant or lactating women
研究组 & 干预措施
Aggrenox Capsule
Other
干预措施: Aggrenox capsule (Drug)
Acetylsalicylic Acid (ASA) 81 mg Tablet
Other
干预措施: Acetylsalicylic Acid (ASA) (Other)
结局指标
主要结局
Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)
时间窗: Up to 124 weeks
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
次要结局
- Number of Patients With Ischemic Vascular Event Composite Endpoint(Up to 124 weeks)
- Number of Patients With Brain (Cerebral) Haemorrhage(Up to 124 weeks)
- Number of Patients With Subarachnoid Haemorrhage(Up to 124 weeks)
- Number of Patients With Transient Ischemic Attack (TIA)(Up to 124 weeks)
- Number of Patients With Acute Coronary Syndrome (ACS)(Up to 124 weeks)
- Number of Patients With Other Vascular Events(Up to 124 weeks)
研究者
研究点 (151)
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