COVID-19
Conditions
Interventions
Trade Name: APIXABAN
Product Name: APIXABAN
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: APIXABAN
Other descriptive name: eliquis
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Fundación para la Investigación Biomédica del Hospital Universitario La Paz (FIBHULP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • PCR-positive COVID-19 infection • Hospitalized for 48 or more hours Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2660 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2660
Exclusion criteria
Exclusion criteria: • Existing indication for anticoagulation, either therapeutic or prophylactic dose • Contraindication to antithrombotic therapy, such as a) ischemic stroke, intracranial bleed, or neurosurgery within 3 months b) Known bleeding within the last 30 days requiring emergency room presentation of hospitalization c) Known major surgery with 14 days (at least 1 hour and/or requires general anesthesia) d) Inherited or acquired active bleeding disorder • Platelet count < 50,000/mcL • Hemoglobin < 8 gm/dL • Renal insufficiency (eGFR < 30 mL/min/1.73 m2) • Pregnancy • Prison inmate • Life expectancy less than 90 days • Unwilling or unable to provide informed consent/unwilling or unable to complete the study protocol • Dual antiplatelet therapy that cannot be discontinued • Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the most effective and safe antithrombotic strategy to prevent the composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality by 30 days following discharge from the hospital.;Secondary Objective: To determine the most effective and safe antithrombotic strategy on (1) the endpoint of venous thromboembolism (inclusive of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism) by 30 days in the study population; (2) the endpoint of arterial thromboembolism (inclusive of ischemic stroke, myocardial infarction, other arterial thromboembolism) by 30 days in the study population; (3) the composite primary outcome by 45 and 90 days following discharge from the hospital;Primary end point(s): First occurrence of any of the components of the composite endpoint of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality by 30 days post-discharge from the hospital;Timepoint(s) of evaluation of this end point: 30 days post-discharge from the hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Venous thromboembolism (inclusive of symptomatic DVT of the upper or lower extremities, symptomatic and/or clinically relevant PE, and other symptomatic venous thrombosis, including cerebral sinus and splanchnic vein thrombosis) by 30 days post-discharge from the hospital; (2) Arterial thromboembolism (inclusive of symptomatic ischemic stroke, myocardial infarction, and other symptomatic arterial thromboembolic events) by 30 days post-discharge from the hospital; (3) the composite primary endpoint by 45 days and 90 days post-discharge from the hospital;Timepoint(s) of evaluation of this end point: (1) 30 days post-discharge from the hospital (2) 30 days post-discharge from the hospital (3) 45 days and 90 days post-discharge from the hospital | — |
Countries
Brazil, Canada, Spain, United States
Contacts
Public ContactRocío María Prieto Pérez
FIBHULP
Outcome results
None listed