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

NCT04168203 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-11-14

Study results available
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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.

Conditions

Interventions

DRUG

Apixaban 2.5 MG

apixaban 2.5 mg orally twice daily for a duration of 12 months

DRUG

Placebo oral tablet

placebo oral tables twice daily for a duration of 12 months

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-11-30
Completion
2025-04-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04168203 on ClinicalTrials.gov