Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19

  • STATUS
    Recruiting
  • End date
    Dec 25, 2021
  • participants needed
    1000
  • sponsor
    Brazilian Clinical Research Institute
Updated on 25 March 2021

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.

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.

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.

Details
Condition Thrombosis, Blood Clots, COVID19, clot, blood clotting
Treatment Placebo, Apixaban 2.5 mg
Clinical Study IdentifierNCT04746339
SponsorBrazilian Clinical Research Institute
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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)
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