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:
Participant gender:
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.