Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19 - the Apollo Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 411
- 试验地点
- 4
- 主要终点
- Number of days alive and out of hospital or emergency department
研究概览
简要总结
Randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic COVID-19 infection and risk factors for thrombosis.
详细描述
Randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic COVID-19 infection and risk factors for thrombosis.
Randomization 1:1 - Group 1 will receive Apixaban 2.5mg twice daily vs. matching placebo (Group 2) for 30 days.
Primary Objective: To evaluate the clinical impact of a strategy of oral anticoagulation with apixaban comparing with placebo on the number of days alive and out of the hospital/emergency department (DAOH) through 30 days in outpatients with symptomatic SARS-CoV2 infection and risk factors for thrombosis.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Outpatients with symptomatic laboratory-proven diagnosis of COVID-19 (any exam that shows acute infection as positive PCR or IgM in a context of acute symptoms ≤ 10 days) AND
- •Negative pregnancy test for women in child bearing period AND
- •D-dimer level ≥ 2x ULN or
- •C-reactive protein (CRP) ≥ 10 mg/L or
- •At least two of the following risk factors:
- •d-dimer level ≥ULN
- •diabetes,
- •chronic kidney disease stage 3
- •cardiopulmonary disease (for example, peripheral arterial disease, coronary artery disease, heart failure, chronic obstructive pulmonary disease),
- •history of PE/DVT,
- •nursing home/SNF resident or severely restricted mobility
- •Body mass index ≥30 kg/m2.
排除标准
- •Age < 18 years-old
- •Patients with indication for full anticoagulation during inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis)
- •Platelets < 50,000 /mm3
- •Use of acetylsalicylic acid > 100 mg per day
- •Use of P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor)
- •Chronic use of NSAIDs
- •Hypersensitivity to apixaban
- •Creatinine clearance < 30 ml/min
- •Pregnancy or breastfeeding
- •Patients contraindicated to anticoagulation (active bleeding, recent major surgery, blood dyscrasia or prohibitive hemorrhage risk as evaluated by the investigator)
- •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
- •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)
研究组 & 干预措施
Apixaban Group
干预措施: Apixaban 2.5 MG (Drug)
Placebo Group
干预措施: Placebo (Drug)
结局指标
主要结局
Number of days alive and out of hospital or emergency department
时间窗: In 30 days
Number of days alive and out of hospital or emergency department through 30 days.
次要结局
- All-cause death(In 30 days)
- Hospitalization due to bleeding(In 30 days)
- Hospitalizations for cardiopulmonary causes(In 30 days)
- All-cause hospitalization(In 30 days)
- Days free of venous thromboembolism(In 30 days)
- Major cardiovascular events (MACE)(In 30 days)