Phase 4 N=390 Randomized Prevention

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

COVID-19 · Venous Thromboembolism · Arterial Thrombosis

Bottom Line

View on ClinicalTrials.gov: NCT04409834 ↗

Enrolled (actual)

390

Serious AEs

3.7%

Results posted

Jan 2024

Primary outcome: Primary: Venous or Arterial Thrombotic Events: Full-dose Anticoagulation Versus Standard-dose Prophylactic Anticoagulation — 4,486; 2,351 Number of wins — p=0.028

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Unfractionated Heparin IV (Drug); Enoxaparin 1 mg/kg (Drug); Clopidogrel (Drug); Unfractionated heparin SC (Drug); Enoxaparin 40 mg SC (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The TIMI Study Group
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Venous or Arterial Thrombotic Events: Full-dose Anticoagulation Versus Standard-dose Prophylactic Anticoagulation	4,486; 2,351	0.028 sig
PRIMARY Venous or Arterial Thrombotic Events: Anti-platelet Therapy Versus No Anti-platelet Therapy	2052; 1994	0.90
SECONDARY Clinically Evident Venous or Arterial Thrombotic Events: Full-dose Anticoagulation Versus Standard-dose Prophylactic Anticoagulation	3,649; 2,021	0.087
SECONDARY Clinically Evident Venous or Arterial Thrombotic Events: Anti-platelet Therapy Versus No Anti-platelet Therapy	1452; 1900	0.53

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.

Eligibility Criteria

Inclusion Criteria

Age ≥18 years (male or female)
Acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)
Currently admitted to an intensive care unit (ICU)

Key Exclusion Criteria

Ongoing (>48 hours) or planned full-dose (therapeutic) anticoagulation for any indication
Ongoing or planned treatment with dual antiplatelet therapy
Contraindication to antithrombotic therapy or high risk of bleeding due to conditions including, but not limited to, any of the following:
History of intracranial hemorrhage, known central nervous system (CNS) tumor or CNS vascular abnormality
Active or recent major bleeding within the past 30 days with untreated source
Platelet count 1.9
History of heparin-induced thrombocytopenia
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):

Ongoing or planned antiplatelet therapy, including aspirin monotherapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04409834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.