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NCT01661101 · ClinicalTrials.gov registry record · Phase 3
Management of Myocardial Injury After Noncardiac Surgery Trial
A Phase 3 study, sponsored by Population Health Research Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,754
- Enrollment target
NCT01661101: Completed Phase 3 study, sponsored by Population Health Research Institute.
NCT01661101 is a Phase 3 study that has completed, run by Population Health Research Institute. The registered enrollment target is 1,754 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (127% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01661101, a Phase 3 study, has completed, sponsored by Population Health Research Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,754 participants
- Enrollment target
Study Summary
Patients who have myocardial injury after noncardiac surgery are at a higher risk of dying than those who do not. One in 10 patients with myocardial injury will die within 30 days of surgery. This risk of death exists up to one year after myocardial injury. There are currently no treatments or guidelines available for heart injury after surgery, but there is evidence that taking a blood-thinner can prevent some of the deaths, both in the short and long-term. The purpose of this trial is to test the effect of two drugs (dabigatran and omeprazole) that may prevent mortality, major cardiovascular complications and major upper gastrointestinal bleeding in patients who have had myocardial injury after noncardiac surgery.
Primary Outcome
A composite of the number of patients suffering vascular mortality, nonfatal myocardial infarction, nonfatal non-hemorrhagic stroke, nonfatal peripheral arterial thrombosis, nonfatal amputation, and nonfatal symptomatic venous thromboembolism (i.e., symptomatic pulmonary embolism or symptomatic proximal deep venous thrombosis).
Interventions
- DRUG Omeprazole
- DRUG Dabigatran
- DRUG Placebo (for Dabigatran)
- DRUG Placebo (for Omeprazole)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,754 participants |
| Start Date | 2013-01 |
| Est. Completion | 2018-03-01 |
| Phase | Phase 3 |
What the finished NCT01661101 record still lists
NCT01661101 is an interventional study that assigns participants to a tested intervention. Its 1,754 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 (127% higher).
The record links to 0 conditions, and to 4 interventions - of which Omeprazole is the first listed.
NCT01661101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01661101 about?
NCT01661101 is a clinical study titled "Management of Myocardial Injury After Noncardiac Surgery Trial". Patients who have myocardial injury after noncardiac surgery are at a higher risk of dying than those who do not. One in 10 patients with myocardial injury will die within 30 days of surgery. This risk of death exists up to one year after myocardial injury. There are currently no treatments or guide...
What is the current status of trial NCT01661101?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,754 participants. The study started on 2013-01. Estimated completion is 2018-03-01.
What interventions are being tested in trial NCT01661101?
The interventions under investigation include: Omeprazole (DRUG), Dabigatran (DRUG), Placebo (for Dabigatran) (DRUG), Placebo (for Omeprazole) (DRUG).
Who is sponsoring clinical trial NCT01661101?
This trial is sponsored by Population Health Research Institute, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01661101's enrollment target sits among peer trials
1,754 129th of 2000 higher than 1,872 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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