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NCT02291419 · ClinicalTrials.gov registry record · Phase 4
Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery
A Phase 4 study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
NCT02291419 is a Phase 4 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 6 participants.
The verdict
NCT02291419, a Phase 4 study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
Study Summary
The purpose of this pilot study is to establish the rate of cardiovascular events in patients with elevated troponins levels after major, non-cardiac surgery and to evaluate the efficacy and safety of FDA approved study drug (ticagrelor) compared to aspirin in these patients. Data from current studies suggest that myocardial injury detected by minor elevations in troponin levels within 3 days after non-cardiac surgery may occur in 10-24% of patients and is associated with an increased risk of mortality at 30 days and 1 year. There are no current guidelines for care of patients with elevated troponin levels in the absence of acute coronary syndrome. This study will assess if the increased risk of these patients is modifiable by an anti-platelet medication and evaluate the safety of this medication. Patients will be randomized in an open label fashion to receive ticagrelor (anti-platelet medication) or 81 mg. aspirin. Patients will be followed on study treatment for 12 months, with the last contact at one month post treatment discontinuation.
Interventions
- DRUG aspirin
- DRUG ticagrelor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02291419
The ClinicalTrials.gov registry entry for NCT02291419 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which aspirin is the first listed.
NCT02291419 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02291419 about?
NCT02291419 is a clinical study titled "Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery". The purpose of this pilot study is to establish the rate of cardiovascular events in patients with elevated troponins levels after major, non-cardiac surgery and to evaluate the efficacy and safety of FDA approved study drug (ticagrelor) compared to aspirin in these patients. Data from current stud...
What is the current status of trial NCT02291419?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2015-07. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02291419?
The interventions under investigation include: aspirin (DRUG), ticagrelor (DRUG).
Who is sponsoring clinical trial NCT02291419?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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