Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in High-Risk Patients With Provoked Venous Thromboembolism
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
Design: U.S.-based, single-center, randomized placebo-controlled trial.
Brief Treatment Description: Low-intensity apixaban (2.5mg twice daily) for extended-duration
secondary prevention of VTE after initial treatment for provoked VTE.
Purpose: To establish the safety and efficacy of low-intensity apixaban versus placebo for
extended prevention of recurrence after provoked VTE in patients with at least one persistent
provoking factor.
Population: Outpatients with provoked VTE with at least one persistent provoking factor.
Enrollment: 600 subjects
Randomization: 1:1
Clinical Site Locations: 1 center (Brigham and Women's Hospital)
Study Duration: 36 months; enrollment period of up to 20 months with 12-month follow-up.
Primary Safety and Efficacy Outcomes:
Primary Safety Outcome: International Society on Thrombosis and Haemostasis (ISTH) major
bleeding at 12 months.
Primary Efficacy Outcome: Symptomatic, recurrent VTE, defined as the composite of deep vein
thrombosis and/or pulmonary embolism at 12 months.
Secondary Efficacy Outcome: The composite of death due to cardiovascular cause, nonfatal
myocardial infarction, stroke or systemic embolism, critical limb ischemia, or coronary or
peripheral ischemia requiring revascularization (major adverse cardiovascular events,
including major adverse limb events) at 12 months.
Follow-Up: Follow-up will consist of Electronic Health Record (EHR) review at 12-months from
study enrollment.
Interim Analysis: An interim analysis for the primary safety and efficacy outcomes will be
performed when 300 subjects have completed 12-month follow-up.