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

A Multicenter, Randomized-Controlled Trial to Evaluate the Efficacy and Safety of Antithrombotic Therapy for Prevention of Arterial and Venous Thrombotic Complications in Critically-Ill COVID-19 Patients

Sponsors

Lead Sponsor: The TIMI Study Group

Source The TIMI Study Group
Brief 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.

Overall Status Recruiting
Start Date 2020-08-05
Completion Date 2021-11-01
Primary Completion Date 2021-11-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Primary endpoint: Venous or arterial thrombotic events 28 days or until hospital discharge, whichever earlier
Secondary Outcome
Measure Time Frame
Key secondary endpoint: Clinically evident venous or arterial thrombotic events 28 days or until hospital discharge, whichever earlier
Enrollment 750
Condition
Intervention

Intervention Type: Drug

Intervention Name: Unfractionated Heparin IV

Description: Unfractionated heparin IV targeting an aPTT of 1.5-2.5 times the control

Intervention Type: Drug

Intervention Name: Enoxaparin 1 mg/kg

Description: Enoxaparin 1 mg/kg SC Q12h

Intervention Type: Drug

Intervention Name: Clopidogrel

Description: Clopidogrel 300 mg PO x1, then clopidogrel 75 mg PO QD

Intervention Type: Drug

Intervention Name: Unfractionated heparin SC

Description: Unfractionated heparin 5,000 IU SC TID

Intervention Type: Drug

Intervention Name: Enoxaparin 40 Mg/0.4 mL Injectable Solution

Description: Enoxaparin 40 mg SC QD

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Vivian Baird-Zars

Phone: 800-385-4444

Email: [email protected]

Location
Facility: Status: Contact: Brigham and Women's Hospital Principal Investigator
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Full-dose anticoagulation + antiplatelet therapy

Type: Experimental

Description: • Full-dose anticoagulation: Unfractionated heparin IV continuous targeting aPTT of 1.5-2.5X control, or Enoxaparin 1 mg/kg SC Q12h • Anti-platelet therapy: Clopidogrel 300 mg PO x1, followed by clopidogrel 75 mg PO QD

Label: Full-dose anticoagulation + no antiplatelet therapy

Type: Experimental

Description: • Full-dose anticoagulation: Unfractionated heparin IV continuous targeting aPTT of 1.5-2.5X control, or Enoxaparin 1 mg/kg SC Q12h

Label: Prophylactic anticoagulation + antiplatelet therapy

Type: Experimental

Description: • Standard prophylactic anticoagulation: Enoxaparin 40 mg SC QD or Unfractionated heparin 5,000 IU SC TID • Antiplatelet therapy: Clopidogrel 300 mg PO x1, followed by clopidogrel 75 mg PO QD

Label: Prophylactic anticoagulation + no antiplatelet therapy

Type: Active Comparator

Description: • Standard prophylactic anticoagulation: Enoxaparin 40 mg SC QD or Unfractionated heparin 5,000 IU SC TID

Acronym COVID-PACT
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

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