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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-05

Study Completion Date

2022-03-10

Brief Summary

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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.

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Detailed Description

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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

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COVID-19 Venous Thromboembolism Arterial Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized-controlled trial - 1) full-dose anticoagulation (FDAC) versus standard-dose prophylactic anticoagulation (SDPAC) (pooled across antiplatelet regimens) and in a subset of patients 2) antiplatelet (AP) versus no AP therapy (pooled across anticoagulant regimens)

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Full-dose anticoagulation (FDAC)

* Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an activated partial thromboplastin time (aPTT) of 1.5-2.5 times the control as per institutional therapeutic target for treatment of venous thrombotic events (VTE)
* Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours
* With or without anti-platelet therapy: Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days

Group Type EXPERIMENTAL

Unfractionated Heparin IV

Intervention Type DRUG

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

Enoxaparin 1 mg/kg

Intervention Type DRUG

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

Clopidogrel

Intervention Type DRUG

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

Standard-dose prophylactic anticoagulation (SDPAC)

* Enoxaparin 40 mg administered subcutaneously (SC) once daily (reduce to 30 mg if creatinine clearance CrCl \<30 ml/min)
* Heparin 5,000 units administered subcutaneous three times daily
* With or without anti-platelet therapy: Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

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

Unfractionated heparin SC

Intervention Type DRUG

Heparin 5,000 units administered subcutaneous three times daily

Enoxaparin 40 mg SC

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Enoxaparin 1 mg/kg

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

Intervention Type DRUG

Clopidogrel

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

Intervention Type DRUG

Unfractionated heparin SC

Heparin 5,000 units administered subcutaneous three times daily

Intervention Type DRUG

Enoxaparin 40 mg SC

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

Intervention Type DRUG

Other Intervention Names

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Lovenox Plavix Lovenox

Eligibility Criteria

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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)

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 central nervous system (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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No