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Anticoagulant
Apixaban for Coronavirus
Phase 3
Waitlist Available
Led By Tracy Wang, MD
Research Sponsored by Thomas L. Ortel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 and 90 days following discharge from hospital
Awards & highlights
Study Summary
This study is evaluating whether a new treatment for blood clots may help reduce the risk of blood clots in patients who have recently been hospitalized.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 and 90 days following discharge from hospital
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 and 90 days following discharge from hospital
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
New, symptomatic ATE (inclusive of ischemic stroke, MI, or peripheral arterial thromboembolism) for up to 30 days after randomization as measured by hospital records.
New, symptomatic VTE (inclusive of DVT, PE, or other venous thrombosis) for up to 30 days after randomization as measured by hospital records.
Perinatal death
+1 moreOther outcome measures
The incidence of all-cause mortality
The incidence of all-cause rehospitalization for up to 90 days after randomization
The individual domains of EQ5D and the EQ5D visual analog scale for 30 and 90 days after randomization
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ApixabanActive Control1 Intervention
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Group II: PlaceboPlacebo Group1 Intervention
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
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Who is running the clinical trial?
Thomas L. OrtelLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,305,277 Total Patients Enrolled
Tracy Wang, MDPrincipal InvestigatorDuke University
2 Previous Clinical Trials
11,658 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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