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
- 尚未招募
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Hierarchical Composite of Cardiovascular and Bleeding Events
研究概览
简要总结
DAN-RELEASE is a national, randomized, registry-based trial including 7,000 participants in Denmark. The trial aims to determine whether discontinuation of long-term aspirin therapy is non-inferior to continued aspirin therapy in older adults with stable ischemic heart disease.
Long-term aspirin therapy is recommended for patients with established ischemic heart disease. However, among clinically stable patients years after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or myocardial infarction (MI), the evidence supporting lifelong aspirin therapy is limited. At the same time, the risk of serious bleeding increases with age.
DAN-RELEASE will therefore compare aspirin discontinuation with continued aspirin therapy in adults aged 65 years or older with stable ischemic heart disease who have remained free from ischemic events for at least two years. The trial will assess whether discontinuing aspirin is non-inferior to continued treatment with respect to cardiovascular and bleeding outcomes.
详细描述
Rationale:
Current guidelines recommend life-long aspirin therapy in patients with chronic coronary syndrome. The evidence supporting long-term aspirin therapy after myocardial infarction (MI) and for chronic coronary syndrome stems primarily from trials conducted in the 1970s and 1980s. Since then, the clinical landscape of MI has evolved markedly: The use of highly sensitive cardiac troponins has led to the diagnosis of smaller MIs, coinciding with a shift from predominantly large ST-segment elevation MI (STEMI) to smaller non-STEMI. Acute revascularization is now a part of the routine care for MI and many patients with stable coronary artery disease undergo percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Population risk factors have improved, and universal use of statins have contributed to plaque stabilization and reduces progression of disease. As a result, long-term prognosis in patients with MI and chronic coronary syndromes has markedly improved.
Therefore, the absolute ischemic benefit of long-term aspirin therapy may be attenuated, while the risk of bleeding, particularly in older patients, remains clinically relevant. These developments warrant a contemporary re-evaluation of the life-long role of aspirin in long-term secondary prevention of cardiovascular disease, especially in elderly patients with stable disease.
Objective:
To evaluate whether discontinuation of long-term aspirin in elderly patients with stable chronic coronary syndrome is non-inferior to continued aspirin therapy with respect to net clinical outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years at randomization
- •Ischemic heart disease (IHD) with index event (myocardial infarction (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)
排除标准
- •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 IHD according to treating physician (i.e. haematological 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
研究组 & 干预措施
Continuation of Aspirin
Participants randomized to this arm will continue their current long-term low-dose aspirin therapy.
干预措施: Continuation of daily low-dose Aspirin (Drug)
Discontinuation of Aspirin
Participants randomized to this arm will discontinue their current long-term low-dose aspirin therapy.
干预措施: Discontinuation of daily low-dose Aspirin (Drug)
结局指标
主要结局
Hierarchical Composite of Cardiovascular and Bleeding Events
时间窗: From randomization until the end of the study, with a minimum follow-up of 1 year
A hierarchical composite endpoint using a win-ratio framework combining cardiovascular death, fatal bleeding, intracranial bleeding, Myocardial infarction, ischemic stroke, and bleeding events (BARC 3-5).
次要结局
- Cardiovascular Death(From randomization until the end of the study, with a minimum follow-up of 1 year)
- Fatal Bleeding (BARC Type 5)(From randomization until the end of the study, with a minimum follow-up of 1 year)
- Intracranial Bleeding (BARC Type 3c)(From randomization until the end of the study, with a minimum follow-up of 1 year)
- Ischemic Stroke(From randomization until the end of the study, with a minimum follow-up of 1 year)
- Myocardial Infarction(From randomization until the end of the study, with a minimum follow-up of 1 year)
- Other Major Bleeding (BARC Types 3a and 3b)(From randomization until the end of the study, with a minimum follow-up of 1 year)
- All-Cause Mortality(From randomization until the end of the study, with a minimum follow-up of 1 year)
- Hospitalization for Cardiovascular Causes(From randomization until the end of the study, with a minimum follow-up of 1 year)
- Peptic Ulcer(From randomization until the end of the study, with a minimum follow-up of 1 year)
- Minor Bleeding(From randomization until the end of the study, with a minimum follow-up of 1 year)
- Abdominal Pain and Discomfort(Baseline and 3, 6, 12, and 24 months after randomization)
- Quality of Life (EQ-5D-5L)(Baseline and 3, 6, 12, and 24 months after randomization)
- Angina Symptoms, Frequency, and Physical Limitations (Seattle Angina Questionnaire)(Baseline and 3, 6, 12, and 24 months after randomization)