Full Anticoagulation Versus Prophylaxis in COVID-19: COALIZAO ACTION Trial (ACTION)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04394377|
Recruitment Status : Completed
First Posted : May 19, 2020
Last Update Posted : June 10, 2021
Pragmatic randomized clinical trial of patients admitted to the hospital with confirmed COVID-19 infection and elevated D-Dimer.
Randomization 1:1 - Group 1 will undergo a routine full anticoagulation (oral or parenteral when needed) strategy; and group 2 will receive usual standard of care with prophylactic anticoagulation
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infection||Drug: Group 1: Rivaroxaban 20mg/d followed by enoxaparin/unfractionated heparin when needed Drug: Group 2: control group with enoxaparin 40mg/d||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||615 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Clinical Trial to Evaluate a Routine Full Anticoagulation Strategy in Patients With Coronavirus (COVID-19) - COALIZAO ACTION Trial|
|Actual Study Start Date :||June 21, 2020|
|Actual Primary Completion Date :||March 26, 2021|
|Actual Study Completion Date :||May 30, 2021|
The routine full anticoagulation strategy will be applied for 30 days. In this strategy, full anticoagulation therapy will be maintained for all patients randomized to group 1 and, depending on the patient's clinical condition, there will be 2 possible routes of administration (oral or parenteral):
Drug: Group 1: Rivaroxaban 20mg/d followed by enoxaparin/unfractionated heparin when needed
Routine full anticoagulation strategy
Patients in this group will receive the usual standard management and currently have no indication of full anticoagulation. Venous thromboembolism (VTE) prophylaxis should be used in group 2 (usual standard of care) as recommended by guidelines.
Drug: Group 2: control group with enoxaparin 40mg/d
Usual standard of care and currently have no indication of full anticoagulation.
- Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days. [ Time Frame: In 30 days ]The primary objective will be analyzed using the win ratio approach comparing every participant of treatment group to every participant of control group to determine a winner.
- Incidence of Venous thromboembolism [ Time Frame: In 30 days ]
- Incidence of acute myocardial infarction [ Time Frame: In 30 days ]
- Incidence of stroke [ Time Frame: In 30 days ]
- Number of days using oxygen therapy [ Time Frame: In 30 days ]
- Peak of troponin [ Time Frame: In 30 days ]
- Peak of D-dimer [ Time Frame: In 30 days ]
- Incidence of Major bleeding and clinically relevant non-major bleeding by the ISTH criteria [ Time Frame: In 30 days ]It will be considered the main safety endpoint
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394377
|Study Chair:||Renato D. Lopes, MD, PhD||BCRI|