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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04409834
Recruitment Status : Not yet recruiting
First Posted : June 1, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID-19 Venous Thromboembolism Arterial Thrombosis Drug: Unfractionated Heparin IV Drug: Enoxaparin 1 mg/kg Drug: Clopidogrel Drug: Unfractionated heparin SC Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: Full-dose anticoagulation + antiplatelet therapy

• 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

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

Drug: Enoxaparin 1 mg/kg
Enoxaparin 1 mg/kg SC Q12h

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

Experimental: Full-dose anticoagulation + no antiplatelet therapy
• Full-dose anticoagulation: Unfractionated heparin IV continuous targeting aPTT of 1.5-2.5X control, or Enoxaparin 1 mg/kg SC Q12h
Drug: Unfractionated Heparin IV
Unfractionated heparin IV targeting an aPTT of 1.5-2.5 times the control

Drug: Enoxaparin 1 mg/kg
Enoxaparin 1 mg/kg SC Q12h

Experimental: Prophylactic anticoagulation + antiplatelet therapy

• 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

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

Drug: Unfractionated heparin SC
Unfractionated heparin 5,000 IU SC TID

Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution
Enoxaparin 40 mg SC QD

Active Comparator: Prophylactic anticoagulation + no antiplatelet therapy
• Standard prophylactic anticoagulation: Enoxaparin 40 mg SC QD or Unfractionated heparin 5,000 IU SC TID
Drug: Unfractionated heparin SC
Unfractionated heparin 5,000 IU SC TID

Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution
Enoxaparin 40 mg SC QD




Primary Outcome Measures :
  1. Primary endpoint: Venous or arterial thrombotic events [ Time Frame: 28 days or until hospital discharge, whichever earlier ]
    Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia, or clinically silent DVT


Secondary Outcome Measures :
  1. Key secondary endpoint: Clinically evident venous or arterial thrombotic events [ Time Frame: 28 days or until hospital discharge, whichever earlier ]
    Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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): NCT04409834


Contacts
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Contact: Vivian Baird-Zars 800-385-4444 vbaird-zars@bwh.harvard.edu

Sponsors and Collaborators
The TIMI Study Group
Investigators
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Study Chair: Marc S Sabatine, MD, MPH TIMI Study Group
Principal Investigator: David A Morrow, MD, MPH TIMI Study Group
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Responsible Party: The TIMI Study Group
ClinicalTrials.gov Identifier: NCT04409834    
Other Study ID Numbers: CCCTN/TIMI COVID-PACT
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin
Calcium heparin
Enoxaparin
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents