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NCT04168203 · ClinicalTrials.gov registry record · Phase 4
Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in High-Risk Patients With Provoked Venous Thromboembolism
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 600
- Enrollment target
NCT04168203: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT04168203 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 600 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04168203, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 600 participants
- Enrollment target
Study 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.
Primary Outcome
DVT is diagnosed as a newly non-compressible venous segment or segments on ultrasonography or a filling defect on computed tomographic (CT) venography, magnetic resonance (MR) venography, or contrast venography. PE is diagnosed based on new mismatched perfusion defect(s) on ventilation perfusion scan, the presence of a new pulmonary artery filling defect on contrast-enhanced chest CT, a new finding of intraluminal filling defect on invasive pulmonary angiography, or evidence of PE at autopsy.
Interventions
- DRUG Placebo oral tablet
- DRUG Apixaban 2.5 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2025-04-08 |
| Phase | Phase 4 |
What the finished NCT04168203 record still lists
NCT04168203 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04168203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04168203 about?
NCT04168203 is a clinical study titled "Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in High-Risk Patients With Provoked Venous Thromboembolism". 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...
What is the current status of trial NCT04168203?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 600 participants. The study started on 2021-03-01. Estimated completion is 2025-04-08.
What interventions are being tested in trial NCT04168203?
The interventions under investigation include: Placebo oral tablet (DRUG), Apixaban 2.5 MG (DRUG).
Who is sponsoring clinical trial NCT04168203?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04168203's enrollment target sits among peer trials
600 137th of 2000 higher than 1,854 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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