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NCT01913483 · ClinicalTrials.gov registry record · Phase 3
ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
A Phase 3 study, sponsored by The Medicines Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 732
- Enrollment target
NCT01913483: Clinical Trial Phase 3 study, sponsored by The Medicines Company.
NCT01913483 is a Phase 3 study that was terminated before completion, run by The Medicines Company. The registered enrollment target is 732 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01913483, a Phase 3 study, was terminated before completion, sponsored by The Medicines Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 732 participants
- Enrollment target
Study Summary
The primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in participants undergoing peripheral endovascular interventions (PEI). The secondary objective is to test whether there were potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.
Primary Outcome
BARC ≥3 includes: Type 3a-3c: clinical, laboratory, and/or imaging evidence of bleeding, which includes any transfusion with overt bleeding, bleeds that result in surgical intervention or administration of IV vasoactive drugs, overt bleeds with a hemoglobin drop greater than or equal to 3 grams (g)/deciliters (dL) to greater than or equal to 5 g/dL, cardiac tamponade caused by bleeding, intracranial hemorrhage, and intraocular bleeds that compromise vision. Type 4: (Coronary Artery Bypass Graf
Interventions
- DRUG Bivalirudin
- DRUG Unfractionated Heparin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 732 participants |
| Start Date | 2013-09-24 |
| Est. Completion | 2016-03-16 |
| Phase | Phase 3 |
Why NCT01913483 stopped before completion
NCT01913483 is an interventional study that assigns participants to a tested intervention. The registered 732 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Bivalirudin is the first listed.
NCT01913483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01913483 about?
NCT01913483 is a clinical study titled "ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial". The primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in participants undergoing peripheral endovascular interventions (PEI). The secondary objective is to test whether there wer...
What is the current status of trial NCT01913483?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 732 participants. The study started on 2013-09-24. Estimated completion is 2016-03-16.
What interventions are being tested in trial NCT01913483?
The interventions under investigation include: Bivalirudin (DRUG), Unfractionated Heparin (DRUG).
Who is sponsoring clinical trial NCT01913483?
This trial is sponsored by The Medicines Company, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01913483's enrollment target sits among peer trials
732 485th of 2000 higher than 1,513 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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