COVID-PACT (antiplatelet therapy)
Trial question
What is the role of clopidogrel in critically ill patients with COVID-19?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 290
290 patients (118 female, 172 male).
Inclusion criteria: adult patients with COVID-19 infection requiring ICU-level of care.
Key exclusion criteria: use of full-dose anticoagulation; use of dual antiplatelet therapy, contraindication to antithrombotic therapy; high risk of bleeding; heparin-induced thrombocytopenia; or ischemic stroke within the past 2 weeks.
Interventions
N=150 clopidogrel (300 mg on the day of randomization, followed by 75 mg/day on subsequent days).
N=140 no clopidogrel (no antiplatelet therapy).
Primary outcome
Rate of death due to venous and arterial thrombotic events through hospital discharge or 28 days
11.3%
15%
15.0 %
11.3 %
7.5 %
3.8 %
0.0 %
Clopidogrel
No
clopidogrel
No significant
difference ↔
No significant difference in the rate of death due to venous and arterial thrombotic events through hospital discharge or 28 days (11.3% vs. 15%; HR 0.9, 95% CI 0.48 to 1.69).
Secondary outcomes
No significant difference in death due to clinically evident venous and arterial thrombotic events (10.7% vs. 9.3%; HR 1.29, 95% CI 0.62 to 2.66).
No significant difference in all-cause mortality (16% vs. 24.3%; HR 0.87, 95% CI 0.51 to 1.49).
No significant difference in venous thrombotic events (17 events vs. 21 events; HR 0.9, 95% CI 0.48 to 1.69).
Safety outcomes
No significant differences in fatal and life-threatening bleeding, GUSTO moderate and severe bleeding.
Conclusion
In adult patients with COVID-19 infection requiring ICU-level of care, clopidogrel was not superior to no clopidogrel with respect to the rate of death due to venous and arterial thrombotic events through hospital discharge or 28 days.
Reference
Erin A Bohula, David D Berg, Mathew S Lopes et al. Anticoagulation and Antiplatelet Therapy for Prevention of Venous and Arterial Thrombotic Events in Critically Ill Patients with COVID-19: COVID-PACT. Circulation. 2022 Nov;146(18):1344-1356.
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