Status:
TERMINATED
Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
AstraZeneca
Conditions:
Myocardial Injury
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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...
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- Written informed consent before any study related procedures are performed.
- A qualifying post-operative T or I troponin elevation (≥2x ULN of assay within 7 days of index surgery and during the index hospitalization).
- Men and women ≥40 years of age if troponin elevation was identified as part of routine post-operative clinical care OR
- Men and women ≥55 years of age if troponin elevation was identified post-operatively as part of screening for the study.
- Undergone non-cardiac surgery requiring an overnight hospital stay.
- 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.
- Able to be randomized within 35 days following the index surgery.
Exclusion
- Post-operative ST-elevation Myocardial Infarction (STEMI).
- Post-operative high-risk non-STEMI, defined as patients with elevated troponin with either:
- active Ischemic EKG changes (≥2 mm of ST-segment depression in at least 2 adjacent leads)
- ongoing hemodynamic instability thought to be ischemia mediated or
- persistent anginal symptoms.
- Planned or urgent coronary angiography/revascularization.
- A current or ongoing indication for dual antiplatelet therapy (DAPT) as determined by the patient's physician.
- History of intracranial hemorrhage
- Bleeding disorder or active bleeding that prevents ticagrelor or aspirin administration.
- Taking any of the following medications at the time of randomization: vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban , fondaparinux, cilostazol, vorapaxar or LMWHs.
- Renal dialysis.
- Hepatic impairment with transaminase ≥3x ULN at time of randomization.
- Known contra-indication for use of ticagrelor.
- Estimated life expectancy of \<1 year.
- Enrolled in another ongoing drug or device research protocol
- A definite non-ischemic explanation for troponin elevation, such as myocarditis or pulmonary embolism.
- A documented hypersensitivity to aspirin.
- Hypersensitivity to ticagrelor or any component of the product.
- Neurological or ophthalmic surgery during the index hospitalization.
- Patients taking strong CYP3A inhibitors and/or CYP3A inducers that cannot be stopped for the course of the study.
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02291419
Start Date
July 1 2015
End Date
June 1 2016
Last Update
February 9 2017
Active Locations (24)
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1
University of South Alabama Health System
Mobile, Alabama, United States, 36617
2
Arkansas Site Management Service, LLC
Little Rock, Arkansas, United States, 72211
3
University of Florida College of Medicine - Jacksonville
Jacksonville, Florida, United States, 32209
4
Florida Hospital Orthopaedic Institute and Fracture Care Center
Orlando, Florida, United States, 32804