NCT04409834

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: The TIMI Study Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, open-label, 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 (in a nested second randomization) for prevention of venous and arterial thrombotic events. In a subcohort without an ongoing indication for antiplatelet therapy at screening, the second randomization is performed to either antiplatelet or no antiplatelet therapy

Conditions

• COVID-19
• Venous Thromboembolism
• Arterial Thrombosis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-08-05
• Primary completion: 2022-03-10
• Completion: 2022-03-10
• First posted: 2020-06-01
• Last updated: 2024-01-19
• Results posted: 2024-01-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study