CompletedPhase 4

Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in High-Risk Patients With Provoked Venous Thromboembolism

United States600 participantsStarted 2021-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Man or woman * Age ≥ 18 years * Objectively-confirmed provoked DVT and/or PE * Treated for at least 3 months with standard therapeutic anticoagulant therapy * Has not suffered symptomatic recurrence during prior anticoagulant therapy * Outpatient follow-up at BWH * AND have at least one of the following persistent provoking VTE risk factors: * Persistent immobility (defined as paralysis, other inability to ambulate freely, bed-bound, wheelchair-bound) * Obesity (defined as BMI ≥ 30 kg/m2) * Heart failure (systolic, diastolic, or combined) * Chronic lung disease (COPD, asthma, interstitial lung disease) * Chronic kidney disease (nephrotic/nephritic syndrome, renal dysfunction with creatinine ≤ 2.5 mg/dL) * Chronic inflammatory/autoimmune disorder (inflammatory arthritis, vasculitis, inflammatory bowel disease, chronic infection) * Atherosclerotic cardiovascular disease (coronary, cerebrovascular, or peripheral artery disease) (up to 35% in each study group may have atherosclerotic cardiovascular disease as a qualifying persistent risk factor) * NOTE: Eligible patients will be allowed to have multiple risk factors, and there will not be a limit as to how many of the above risk factors a subject may have. In addition, we will place no limit on the number of patients included with multiple risk factors. A study population with multiple risk factors is highly representative of the provoked VTE population and will provide the greatest general…

What they're measuring

Frequency of Symptomatic, Recurrent VTE Defined as the Composite of Deep Vein Thrombosis and/or Pulmonary Embolism

Timeframe: 12 months

Frequency of Major Bleeding

Timeframe: 12 months

Trial details

NCT IDNCT04168203

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-30

Results submitted2025-09-15