Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery

• Status: Terminated
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: AstraZeneca
• Treatments: Aspirin; Ticagrelor

Criteria

Inclusion Criteria:

1. Written informed consent before any study related procedures are performed.

2. A qualifying post-operative T or I troponin elevation (≥2x ULN of assay within 7 days of index surgery and during the index hospitalization).

3. Men and women ≥40 years of age if troponin elevation was identified as part of routine post-operative clinical care OR

4. Men and women ≥55 years of age if troponin elevation was identified post-operatively as part of screening for the study.

5. Undergone non-cardiac surgery requiring an overnight hospital stay.

6. Women of childbearing potential who are sexually active must have a negative pregnancy test at enrollment and agree to use adequate contraception from screening until 30 days after receiving the last dose of study drug.

7. Able to be randomized within 35 days following the index surgery.

Exclusion Criteria:

1. Post-operative ST-elevation Myocardial Infarction (STEMI).

2. Post-operative high-risk non-STEMI, defined as patients with elevated troponin with either:

1. active Ischemic EKG changes (≥2 mm of ST-segment depression in at least 2 adjacent leads)

2. ongoing hemodynamic instability thought to be ischemia mediated or

3. persistent anginal symptoms.

3. Planned or urgent coronary angiography/revascularization.

4. A current or ongoing indication for dual antiplatelet therapy (DAPT) as determined by the patient's physician.

5. History of intracranial hemorrhage

6. Bleeding disorder or active bleeding that prevents ticagrelor or aspirin administration.

7. Taking any of the following medications at the time of randomization: vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban , fondaparinux, cilostazol, vorapaxar or LMWHs.

8. Renal dialysis.

9. Hepatic impairment with transaminase ≥3x ULN at time of randomization.

10. Known contra-indication for use of ticagrelor.

11. Estimated life expectancy of <1 year.

12. Enrolled in another ongoing drug or device research protocol

13. A definite non-ischemic explanation for troponin elevation, such as myocarditis or pulmonary embolism.

14. A documented hypersensitivity to aspirin.

15. Hypersensitivity to ticagrelor or any component of the product.

16. Neurological or ophthalmic surgery during the index hospitalization.

17. Patients taking strong CYP3A inhibitors and/or CYP3A inducers that cannot be stopped for the course of the study.