Phase 3
Completed N=1,217
COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis
Source: ClinicalTrials.gov NCT04650087 ↗Enrolled (actual)
1,217
Serious AEs
11.3%
Results posted
Feb 2025
Primary outcomePrimary: Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records. — 2.31; 2.13 percentage of participants
◆ Published Evidence
Established
36citations · ~12 / year
Effect of Thromboprophylaxis on Clinical Outcomes After COVID-19 Hospitalization.
Summary
A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge
Linked Publications (2)
-
Effect of Thromboprophylaxis on Clinical Outcomes After COVID-19 Hospitalization.
-
Prophylactic anticoagulants for non-hospitalised people with COVID-19.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records. |
2.31; 2.13 | — |
| SECONDARY The Composite Outcome of All-cause Mortality and the EuroQoL Group 5-Dimension (EQ5D) Index Score. |
0.93; 0.93 | — |
| SECONDARY The Composite Outcome of All-cause Mortality and the EQ5D Index Score. |
0.94; 0.94 | — |
| SECONDARY The Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records. |
2.80; 3.11 | — |
| SECONDARY New, Symptomatic VTE (Inclusive of DVT, PE, or Other Venous Thrombosis) for up to 30 Days After Randomization as Measured by Hospital Records. |
0.82; 0.82 | — |
| SECONDARY New, Symptomatic ATE (Inclusive of Ischemic Stroke, MI, or Peripheral Arterial Thromboembolism) for up to 30 Days After Randomization as Measured by Hospital Records. |
0.49; 0.16 | — |
Eligibility Criteria
Inclusion Criteria
- • Age ≥ 18 years
- PCR-positive COVID-19 infection
- Hospitalized for two or more days
Exclusion Criteria
- Pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein thrombosis; atrial fibrillation; mechanical cardiac valve)
- Contraindication to antithrombotic therapy (e.g., known bleeding within the last 30 days requiring emergency room presentation or hospitalization; major surgery within 14 days; ischemic stroke, intracranial bleed or neurosurgery within 3 months.
- 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 or CYP3A4
Data sourced from ClinicalTrials.gov (NCT04650087) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.