A Phase 4 interventional study of ticagrelor and aspirin in Myocardial Injury, sponsored by The Cleveland Clinic. Terminated at 24 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-02-09.
Sponsored by The Cleveland Clinic · Phase 4, Interventional, and Prevention
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.
The objective of this pilot study is to establish the rate of cardiovascular events in patients with elevated troponins levels post major, non-cardiac surgery and to evaluate the efficacy and safety of ticagrelor treatment 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 (ACS) and it is not certain if this is a modifiable disease process. Ticagrelor is a direct, reversible inhibitor of the platelet P2Y12ADP-receptor. It has been shown to be superior to clopidogrel in the setting of ACS. The clinical benefit of treating patients with port-operative troponin elevation with antiplatelet agents remains unexplored. The short half-life of ticagrelor makes it favorable to use in this setting.
This is an open label, randomized, parallel group study comparing ticagrelor to aspirin in patients who experience troponin elevations post major non-cardiac surgery. Patients will be randomized in an open-label fashion to receive either ticagrelor 90 mg twice daily or aspirin 81 mg once daily. Patients will be followed for 13 months post randomization (12 months of treatment and a phone call 30 days after study drug discontinuation). The maximum duration of treatment will be 12 months.
Follow-up visits will occur at Month 1, Month 6, and Month 12. Phone calls will be made at Month 3, Month 9, and at 30 days after study drug discontinuation.
Up to 1000 patients with post-operative troponin elevation ≥2x ULN within first 7 postoperative days, will be enrolled in the study.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 6 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Post-operative high-risk non-STEMI, defined as patients with elevated troponin with either:
ticagrelor 90mg bid
Drug: ticagrelor
Patients in the aspirin arm will receive aspirin 81 mg daily orally
Drug: aspirin
ticagrelor 90 mg bid
Also known as: Brilinta
aspirin 81 mg daily
Also known as: Bayer, ASA
Major Adverse Cardiovascular Events
Time to first occurence of the composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Coronary Revascularization or Non-fatal Stroke. The number of patients with events is reported.
Time frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Cardiovascular Death
Time to first occurence of Cardiovascular death. The number of patients with events was reported.
Time frame: Up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Non-fatal Myocardial Infarction or Coronary Revascularization
Time to first occurence of Non-fatal myocardial infarction or coronary revascularization. The number of participants with events was reported.
Time frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
All-cause Death
Time to first occurence of All-cause death. The number of participants with events was reported.
Time frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Non-fatal Stroke
Time to first occurence of Non-fatal stroke. The number of participants with events was reported.
Time frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions
Time frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
| Milestone | Ticagrelor | Aspirin |
|---|---|---|
| Started | 1 | 5 |
| Completed | 0 | 0 |
| Not completed | 1 | 5 |
| Withdrew: Early study termination | 1 | 5 |
Time to first occurence of the composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Coronary Revascularization or Non-fatal Stroke. The number of patients with events is reported.
| Participants | Ticagrelor | Aspirin |
|---|---|---|
| Major Adverse Cardiovascular Events | 0 | 0 |
Time to first occurence of Cardiovascular death. The number of patients with events was reported.
| Participants | Ticagrelor | Aspirin |
|---|---|---|
| Cardiovascular Death | 0 | 0 |
Time to first occurence of Non-fatal myocardial infarction or coronary revascularization. The number of participants with events was reported.
| Participants | Ticagrelor | Aspirin |
|---|---|---|
| Non-fatal Myocardial Infarction or Coronary Revascularization | 0 | 0 |
Time to first occurence of All-cause death. The number of participants with events was reported.
| Participants | Ticagrelor | Aspirin |
|---|---|---|
| All-cause Death | 0 | 0 |
Time to first occurence of Non-fatal stroke. The number of participants with events was reported.
| Participants | Ticagrelor | Aspirin |
|---|---|---|
| Non-fatal Stroke | 0 | 0 |
| Participants | Ticagrelor | Aspirin |
|---|---|---|
| The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions | 0 | 0 |
Collected over Patients were monitored up to 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ticagrelor | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Aspirin | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Customized(Participants) | Ticagrelor | Aspirin | Total |
|---|---|---|---|
| > or = to 40 years | 1 | 5 | 6 |
| Sex: Female, Male(Participants) | Ticagrelor | Aspirin | Total |
|---|---|---|---|
| Female | 0 | 3 | 3 |
| Male | 1 | 2 | 3 |
| Region of Enrollment(Participants) | Ticagrelor | Aspirin | Total |
|---|---|---|---|
| United States | 1 | 5 | 6 |
Plan to share: No
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