Intermediate-dose vs Standard Prophylactic Anticoagulation and Statin vs Placebo in ICU Patients … (NCT04486508) | Clinical Trial Compass
CompletedPhase 3
Intermediate-dose vs Standard Prophylactic Anticoagulation and Statin vs Placebo in ICU Patients With COVID-19
Iran600 participantsStarted 2020-07-30
Plain-language summary
In a 2x2 factorial design randomized controlled trial, the investigators aim to elaborate the safety and efficacy of two pharmacological regimens on outcomes of critically-ill patients with COVID-19. The first randomization entails open-label assignment to intermediate versus standard dose prophylactic anticoagulation. The investigators hypothesize that intermediate dose compared with standard prophylactic dose anticoagulation will have a superior efficacy with respect to a composite of venous thromboembolism (VTE), requirement for extracorporeal membrane oxygenation (ECMO), or all-cause mortality. The second randomization will be double-blind assignment of the included patients to atorvastatin 20mg daily versus matching placebo. The hypothesis is that statin therapy, compared with placebo, will reduce the composite of VTE, need for ECMO, or all-cause mortality.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult patients (≥18 years), with polymerase chain reaction (PCR)-confirmed COVID-19 admitted to ICU within 7 days of initial hospitalization , who do not have another firm indication for anticoagulation (such as mechanical valve, high-risk atrial fibrillation (AF), VTE, or left ventricle (LV) thrombus),who are not enrolled in another blinded randomized trial, and are willing to participate in the study and provide informed consent .
✓. Estimated survival of at least 24 hours at the discretion of enrolling physician
Exclusion criteria
✕. Weight \<40 Kilogram (kg)
✕. Overt bleeding at the day of enrollment
✕. Known major bleeding within 30 days (according to the Bleeding Academic Research Consortium (BARC) definition, Appendix A)
✕. Platelet count \<50,000/Fl
✕. Pregnancy (as confirmed by Beta human chorionic gonadotropin (HCG) testing among female patients \<50 years)
✕. Patients on Extracorporeal Membrane Oxygenation (ECMO)
What they're measuring
1
a composite of acute VTE, arterial thrombosis, treatment with ECMO, or all-cause mortality
Timeframe: 30 days from enrollment
Trial details
NCT IDNCT04486508
SponsorRajaie Cardiovascular Medical and Research Center