6/28/23, 12:45 AM ASPIRE Pathway Feedback Search Clinical Topics Home Studies ASPIRE ASPIRE Disease Disease Deep vein thrombosis Pulmonary embolism Trial question What is the role of low-dose aspirin in patients who have had a first episode of unprovoked VTE and have a high risk of recurrence after anticoagulants are discontinued? Study design Multi-center Double blinded RCT Population Characteristics of study participants 46.0% female N = 822 54.0% male 822 patients (375 female, 447 male) Inclusion criteria: patients who had completed initial anticoagulant therapy after a first episode of unprovoked VTE Key exclusion criteria: first unprovoked episode of VTE > 2 years before enrollment; indication or contraindication for the use of aspirin, other antiplatelet therapy, or a nonsteroidal antiinflammatory drug; indication for continuing oral anticoagulation therapy; or other medical problems that would interfere with participation in the trial or limit life expectancy Interventions N=411 aspirin (100 mg PO once daily, for up to 4 years) N=411 placebo (matching placebo PO once daily, for up to 4 years) https://web.pathway.md/studies/rec7YXr21jVxwlsFZ 1/2 6/28/23, 12:45 AM ASPIRE Pathway Primary outcome Incidence of recurrent venous thromboembolism 6.5 % / y 6.5 4.9 % / y 4.8 3.3 % / y 1.6 % / y No significant difference 0.0 % / y Aspirin Placebo No significant difference in the incidence of recurrent VTE (4.8% / y vs. 6.5% / y; HR 0.74, 95% CI 0.52 to 1.05) Secondary outcomes Significant decrease in the incidence of major vascular events (5.2% / y vs. 8% / y; HR 0.66, 95% CI 0.48 to 0.92) Significant decrease in the incidence of VTE, myocardial infarction, stroke, major bleeding, or death (6% / y vs. 9% / y; HR 0.67, 95% CI 0.49 to 0.91) Safety outcomes No significant difference in major or clinically relevant nonmajor bleeding or serious adverse events. Conclusion In patients who had completed initial anticoagulant therapy after a first episode of unprovoked VTE, aspirin was not superior to placebo with respect to the incidence of recurrent VTE. Reference Brighton TA, Eikelboom JW, Mann K et al. Low-dose aspirin for preventing recurrent venous thromboembolism. N Engl J Med. 2012 Nov 22;367(21):1979-87. Open reference URL https://web.pathway.md/studies/rec7YXr21jVxwlsFZ 2/2