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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 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 600 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04168203
The ClinicalTrials.gov registry entry for NCT04168203 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04168203 reports 0 study locations.
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.
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