Overview

Prevention of Arteriovenous Thrombotic Events in Critically-Ill COVID-19 Patients Trial

Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
0
Participant gender:
All
Summary
This is a multicenter, open-label, 2x2 factorial, randomized-controlled trial in critically-ill patients with novel coronavirus disease 2019 (COVID-19) evaluating the efficacy and safety of full-dose vs. standard prophylactic dose anticoagulation and of antiplatelet vs. no antiplatelet therapy for prevention of venous and arterial thrombotic events.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The TIMI Study Group
Treatments:
Calcium heparin
Clopidogrel
Enoxaparin
Enoxaparin sodium
Heparin
Criteria
Inclusion Criteria:

1. Age ≥18 years (male or female)

2. Acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)

3. Currently admitted to an intensive care unit (ICU)

Key Exclusion Criteria:

1. Ongoing (>48 hours) or planned full-dose (therapeutic) anticoagulation for any
indication

2. Ongoing or planned treatment with dual antiplatelet therapy

3. Contraindication to antithrombotic therapy or high risk of bleeding due to conditions
including, but not limited to, any of the following:

1. History of intracranial hemorrhage, known CNS tumor or CNS vascular abnormality

2. Active or recent major bleeding within the past 30 days with untreated source

3. Platelet count <70,000 or known functional platelet disorder

4. Fibrinogen <200 mg/dL

5. International normalized ratio (INR) >1.9

4. History of heparin-induced thrombocytopenia

5. Ischemic stroke within the past 2 weeks

Patients who meet the following criterion are excluded from the second randomization
(antiplatelet therapy vs. no antiplatelet therapy):

1. Ongoing or planned antiplatelet therapy, including aspirin monotherapy