Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. At the time of writing, there have been 150 000 confirmed cases and 3500 deaths. Apart from the morbidity and mortality directly related to COVID-19 cases, society has had to also cope with complex political and economic repercussions of this disease.
At present, and despite pressing need for therapeutic intervention, management of patients with COVID-19 is entirely supportive. Despite the majority of patients experiencing a mild respiratory illness a subgroup, and in particular those with pre-existing cardiovascular disease, will experience severe illness that requires invasive cardiorespiratory support in the intensive care unit.
Furthermore, the severity of COVID-19 disease (as well as the likelihood of progressing to severe disease) appears to be in part driven by direct injury to the cardiovascular system. Analysis of data from two recent studies confirms a significantly higher likelihood of acute cardiac injury in patients who have to be admitted to intensive care for the management of COVID-19 disease.
The exact type of acute of cardiac injury that COVID-19 patients suffer remains unclear. There is however mounting evidence that heart attack like events are responsible. Tests ordinarily performed to definitely assess for heart attacks will not be possible in very sick COVID-19 patients. Randomising patients to cardioprotective medicines will help us understand the role of the cardiovascular system in COVID-19 disease. It will also help us determine if there is more we can do to treat these patients.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed COVID-19 infection
- •Age =/>40 or diabetes or known coronary disease or hypertension
- •Requires hospital admission for further clinical management.
排除标准
- •Clear evidence of an acute coronary syndrome or myo-pericarditis that requires specific treatment that precludes randomization.
- •Evidence of active bleeding
- •Age <18 years
研究组 & 干预措施
Active Arm
干预措施: Aspirin 75mg (Drug)
Active Arm
干预措施: Clopidogrel 75mg (Drug)
Active Arm
干预措施: Rivaroxaban 2.5 MG (Drug)
Active Arm
干预措施: Atorvastatin 40mg (Drug)
Active Arm
干预措施: Omeprazole 20mg (Drug)
结局指标
主要结局
All-cause mortality
时间窗: 30 days
All-cause mortality
次要结局
- An ordinal outcome measure of 4 levels (1 - Death, 2 - Intensive Care Unit environment, 3 - In Hospital, 4 - At Home).(30 days)
- Peak troponin(7- and 30- days)
- Time to discharge(Up to 30 days)
- Need for non-invasive ventilatory support(30 days)
- Need for invasive ventilatory support(30 days.)
- Need for mechanical circulatory support(30 days)
- Need for renal replacement therapy(30 days)
- Bleeding Academic Research Consortium (BARC) bleed event(30 days)
- Cessation of randomized active arm therapy(30 days)