Status:
TERMINATED
Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19
Lead Sponsor:
Brazilian Clinical Research Institute
Collaborating Sponsors:
Hospital Israelita Albert Einstein
Hospital do Coracao
Conditions:
Covid19
Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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. R...
Eligibility Criteria
Inclusion
- 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
- CRP ≥ULN
- age ≥65,
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
March 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT04746339
Start Date
March 4 2021
End Date
May 30 2022
Last Update
August 25 2022
Active Locations (4)
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1
Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará, Brazil
2
Hospital Universitário São Francisco de Assis
Bragança Paulista, São Paulo, Brazil
3
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
4
Hospital Santa Paula
São Paulo, Brazil