Randomized Clinical Trial to Evaluate a Routine Full Anticoagulation Strategy in Patients With Coronavirus (COVID-19) - COALIZAO ACTION Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 615
- 试验地点
- 38
- 主要终点
- Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days.
研究概览
简要总结
Pragmatic randomized clinical trial of patients admitted to the hospital with confirmed COVID-19 infection and elevated D-Dimer.
Randomization 1:1 - Group 1 will undergo a routine full anticoagulation (oral or parenteral when needed) strategy; and group 2 will receive usual standard of care with prophylactic anticoagulation
详细描述
Patients admitted to hospital with confirmed COVID-19, and who meet the eligibility criteria will be invited to participate in the proposed study. Following the application of the informed consent form, they will collect the D-dimer (if they have not yet collected it routinely from the hospital) and confirm the value over the normal limit in patients with confirmed COVID-19, will be randomized to 2 groups in the 1:1 ratio. Group 1 will follow the strategy of routine use of full anticoagulation therapy (oral or parenteral when indicated); and group 2 will follow the usual standard care with in-hospital prophylactic anticoagulation (without routine full anticoagulation).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed diagnosis of COVID-19 admitted to hospital;
- •Duration of symptoms related to hospitalization ≤ 14 days;
- •Patients ≥ 18 year old;
- •D-dimer above the upper limit of normal (collected until 72 hours before the randomization);
- •Agreement to participate by providing the informed consent form (ICF).
排除标准
- •Patients with indication for full anticoagulation during inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis);
- •Platelets < 50,000 /mm3
- •Need for ASA therapy > 100 mg;
- •Need for P2Y12 inhibitor therapy (clopidogrel, ticagrelor or prasugrel);
- •Chronic use of non-hormonal anti-inflammatory drugs;
- •Sustained uncontrolled systolic blood pressure (BP) of ≥180 mmHg or diastolic BP of ≥100 mmHg;
- •INR > 1,5;
- •Patients contraindicated to full anticoagulation (active bleeding, liver failure, blood dyscrasia or prohibitive hemorrhage risk as evaluated by the investigator);
- •Criteria for disseminated intravascular coagulation (DIC);
- •A history of hemorrhagic stroke or any intracranial bleeding at any time in the past or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (AV) malformation, or aneurysm;
- •Active cancer (excluding non-melanoma skin cancer) defined as cancer not in remission or requiring active chemotherapy or adjunctive therapies such as immunotherapy or radiotherapy;
- •Hypersensitivity to rivaroxaban;
- •Use of strong inhibitors of cytochrome P450 (CYP) 3A4 and/or P-glycoprotein (P-gp) (e.g. protease inhibitors, ketoconazole, Itraconazole) and/or use of P-gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort);
- •Known HIV infection;
- •Creatinine clearance < 30 ml/min according to the Cockcroft-Gault Formula;
- •Pregnancy or breastfeeding.
结局指标
主要结局
Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days.
时间窗: In 30 days
The primary objective will be analyzed using the win ratio approach comparing every participant of treatment group to every participant of control group to determine a winner.
次要结局
- Incidence of stroke(In 30 days)
- Number of days using oxygen therapy(In 30 days)
- Peak of troponin(In 30 days)
- Peak of D-dimer(In 30 days)
- Incidence of Major bleeding and clinically relevant non-major bleeding by the ISTH criteria(In 30 days)
- Incidence of acute myocardial infarction(In 30 days)
- Incidence of Venous thromboembolism(In 30 days)