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NCT00433966 · ClinicalTrials.gov registry record · Phase 3
Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
A Phase 3 study, sponsored by Cardiovascular Research Foundation, New York.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,602
- Enrollment target
NCT00433966: Completed Phase 3 study, sponsored by Cardiovascular Research Foundation, New York.
NCT00433966 is a Phase 3 study that has completed, run by Cardiovascular Research Foundation, New York. The registered enrollment target is 3,602 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (367% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00433966, a Phase 3 study, has completed, sponsored by Cardiovascular Research Foundation, New York.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,602 participants
- Enrollment target
Study Summary
The primary objectives of the trial are: 1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in patients with acute myocardial infarction undergoing a primary angioplasty strategy. 2. To establish the safety and efficacy of the slow rate release paclitaxel-eluting TAXUS™ stent compared to an otherwise identical uncoated bare metal EXPRESS2™ stent.
Primary Outcome
Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting).
Interventions
- DRUG Bivalirudin
- DRUG Unfractionated heparin
- DEVICE Bare metal stent
- DEVICE Paclitaxel-eluting stent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,602 participants |
| Start Date | 2005-03 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
What the finished NCT00433966 record still lists
NCT00433966 is an interventional study that assigns participants to a tested intervention. Its 3,602 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (367% higher).
The record links to 0 conditions, and to 4 interventions - of which Bivalirudin is the first listed.
NCT00433966 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00433966 about?
NCT00433966 is a clinical study titled "Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction". The primary objectives of the trial are: 1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in patients with acute myocardial infarction undergoing a primary angioplasty strateg...
What is the current status of trial NCT00433966?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,602 participants. The study started on 2005-03. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00433966?
The interventions under investigation include: Bivalirudin (DRUG), Unfractionated heparin (DRUG), Bare metal stent (DEVICE), Paclitaxel-eluting stent (DEVICE).
Who is sponsoring clinical trial NCT00433966?
This trial is sponsored by Cardiovascular Research Foundation, New York, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00433966's enrollment target sits among peer trials
3,602 68th of 2000 higher than 1,933 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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