Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT04409834
PHASE4

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

Sponsor: The TIMI Study Group

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

390

Start Date

2020-08-05

Completion Date

2022-03-10

Last Updated

2026-10-27

Healthy Volunteers

No

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)

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States