EPIC (Evaluating Perioperative Ischemia Reduction by Clonidine)
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|ClinicalTrials.gov Identifier: NCT00335582|
Recruitment Status : Unknown
Verified May 2009 by University Health Network, Toronto.
Recruitment status was: Active, not recruiting
First Posted : June 12, 2006
Last Update Posted : October 9, 2009
In Canada 1 patient in 200 dies within 30 days of an operation. More than half of these deaths are the direct result of a heart related complication. This cause of death happens 4 times more often than in the same people who do not have an operation. We do not have an effective way to stop these heart attacks. Stress causes the heart rate and the blood pressure to go up which causes the heart to work harder and may be the reason for some heart attacks. One group of drugs that stops the heart from working harder and decrease the number of heart related complications are BETA-BLOCKERS. We wish to add another drug, which has been shown to reduce heart rate and blood pressure, will reduce the number of heart attacks after an operation. CLONIDINE has been shown to reduce heart attacks after operations. Since we know it is not a good idea to stop beta-blockers we want to see if giving clonidine as well as a beta-blocker is safe and has the desired effect of decreasing the number of heart attacks. We want to find out how good the combination of these two drugs are at decreasing the number of heart attacks.
Hypothesis: The addition of clonidine to chronic b-blockade will reduce mortality and cardiac morbidity among intermediate-to-high risk patients undergoing non-cardiac surgery.
|Condition or disease||Intervention/treatment||Phase|
|Heart Disease||Drug: clonidine hydrochloride||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The EPIC (Evaluating Perioperative Ischemia Reduction by Clonidine) Study: A Randomized, Double-blinded Trial of Clonidine for Reducing Cardiac Morbidity and Mortality Following Non-cardiac Surgery.|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||August 2009|
|Estimated Study Completion Date :||December 2009|
- Drug: clonidine hydrochloride
One hour prior to surgery, patients randomized to the treatment arm will receive clonidine as both a 0.2 mg oral tablet and 0.2 mg/day transdermal patch patch will be removed on postoperative day 4 (or hospital discharge, whichever is earlier)
- To preform feasibility study looking at the safety and efficacy of adding clonidine to chronic b-blockade on patient-relevant outcomes (mortality, myocardial infarction, prolonged hospitalization) in large randomized controlled trials [ Time Frame: Daily until discharge and 30 days after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335582
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Duminda Wijeysundera, MD||Toronto General Hospital, University Health Network|