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

NCT04409834 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2024-01-19

Study results available
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Summary

The researchers wanted to learn how to help sick patients who are in the hospital because of COVID-19. They are trying to find out the best way that is safe to stop blood clots that could be dangerous from forming in patients with COVID-19. This research study happened at 34 hospitals.

All patients in the study took medicines that help prevent blood clots. These medicines are called blood thinners or anticoagulants. Patients got different amounts of blood thinners to see what works better and is safer. Researchers randomly chose some patients to get more and some to get less.

The researchers also wanted to know if another medicine called clopidogrel can safely help stop blood clots from forming. This kind of medicine helps keep parts of the blood, called platelets, from sticking together. In some patients who did not have other reasons to take a platelet-blocker the researchers randomly chose the patient to take clopidogrel or not. This type of medicine is also called an antiplatelet.

Conditions

  • COVID-19
  • Venous Thromboembolism
  • Arterial Thrombosis

Interventions

DRUG

Unfractionated Heparin IV

Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of VTE

DRUG

Enoxaparin 1 mg/kg

Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours

DRUG

Clopidogrel

Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily orally on subsequent days

DRUG

Unfractionated heparin SC

Heparin 5,000 units administered subcutaneous three times daily

DRUG

Enoxaparin 40 mg SC

Enoxaparin 40 mg administered subcutaneously (SC) once daily (reduce to 30 mg if CrCl\<30 ml/min)

Sponsors & Collaborators

  • The TIMI Study Group

    lead OTHER

Principal Investigators

  • Marc S Sabatine, MD, MPH · The TIMI Study Group

  • David A Morrow, MD, MPH · The TIMI Study Group

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2022-03-10
Completion
2022-03-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04409834 on ClinicalTrials.gov