The RELEASE Trial: Reconsidering Long-Term Aspirin in the Elderly in Secondary Prevention of Cardiovascular Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 7,000
- 试验地点
- 2
- 主要终点
- The following components are included in the primary endpoint, ranked in hierarchical order: 1. Cardiovascular death 2. Fatal bleeding (BARC type 5) 3. Intracranial bleeding (BARC type 3c) 4. Ischemic stroke 5. MI 6. Other major bleeding (BARC type 3a [moderate, requires transfusion] and 3b [major, may need surgery])
研究概览
简要总结
To evaluate whether discontinuation of long-term aspirin in patients >65 years with stable chronic coronary syndrome is non-inferior to continued aspirin therapy with respect to net clinical outcome.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years at randomization • Ischemic heart disease with index event (MI, percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)) >2 years previously • Since index event free from ischemic cardiovascular events (MI, ischemic stroke, or transitory ischemic attack) or any coronary revascularization procedure (PCI/CABG) • Currently treated with low dose aspirin (≤150 mg daily, based on prescription fillings and self-reported)
排除标准
- •Any history of ischemic stroke • Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy • Indication for antiplatelet treatment other than secondary prevention of ischemic heart disease according to treating physician (i.e. hematological diseases, peripheral artery disease) • Any revascularization procedure for peripheral artery disease • Any history of stent thrombosis or stenting of the left main coronary artery • Other contraindications to aspirin discontinuation according to treating physician • Not being able to understand Danish
结局指标
主要结局
The following components are included in the primary endpoint, ranked in hierarchical order: 1. Cardiovascular death 2. Fatal bleeding (BARC type 5) 3. Intracranial bleeding (BARC type 3c) 4. Ischemic stroke 5. MI 6. Other major bleeding (BARC type 3a [moderate, requires transfusion] and 3b [major, may need surgery])
The following components are included in the primary endpoint, ranked in hierarchical order: 1. Cardiovascular death 2. Fatal bleeding (BARC type 5) 3. Intracranial bleeding (BARC type 3c) 4. Ischemic stroke 5. MI 6. Other major bleeding (BARC type 3a [moderate, requires transfusion] and 3b [major, may need surgery])
次要结局
- The secondary endpoints of the trial are listed below: - Each component of the primary composite outcome - All-cause mortality - Hospitalization for cardiovascular causes - Peptic ulcer - Patient-reported outcomes o Minor bleeding o Abdominal pain/discomfort o Quality of life o Health-related quality of life, anxiety and depressive symptoms, and functional status o Angina symptoms o Lifestyle behaviour
研究者
Axel Diederichsen
Scientific
Odense University Hospital