Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,539
- 试验地点
- 2
- 主要终点
- Cardiovascular events
研究概览
简要总结
The purpose of this study is to determine the effects of low-dose aspirin for the primary prevention of vascular events in patients with type 2 diabetes in Japan.
详细描述
There is a worldwide epidemic of diabetes and the number of individuals with diabetes is set to increase further. As individuals with diabetes are at high risk of accelerated atherosclerosis and thrombotic vascular events, the significant proportion of the cardiovascular disease burden is projected to be among this population. JPAD is a multicenter study with a prospective randomized open, blinded end-point (PROBE) design. The doses administered are aspirin 81 mg/day or 100 mg/day, the latter being enteric-coated Aspirin.
The primary objective was to compare the effect of aspirin on atherosclerotic events including cardiovascular events, cerebral vascular event, and other vascular events.
We also analyze hemorrhagic events in this RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have type 2 diabetes mellitus (30 or more years old and 85 years old or less).
- •Patients give their informed consent to participate.
排除标准
- •Patient has electrocardiographic changes, including ischemic ST-segment depression, ST-segment elevation, or pathologic Q waves.
- •Patient has fixed ischemic heart disease, utilizing coronary angiography.
- •Patient has cerebral vascular disease, including cerebral infarction, past hemorrhage, and experience of transient ischemic attack.
- •Patient has arteriosclerotic disease, which needs internal medicine and/or surgical medical treatment.
- •Patient has already taken the following anti-platelet or anti-thrombotic medicine: aspirin, ticlopidine, cilostazol, dipyridamole, trapidil, warfarin, and argatroban.
- •Patient has severe gastric and/or duodenal ulcer.
- •Patient has severe liver dysfunction.
- •Patient has severe renal dysfunction.
- •Patient has allergy for aspirin.
- •Patient has atrial fibrillation.
- •Pregnancy or the possible case of pregnancy.
研究组 & 干预措施
1
Aspirin use
干预措施: Aspirin (Drug)
2
No aspirin use
干预措施: No aspirin (Drug)
结局指标
主要结局
Cardiovascular events
时间窗: five years (median)
Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment
时间窗: five years (median)
Cerebral vascular events
时间窗: five years (median)
次要结局
未报告次要终点