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Sponsors and Collaborators: |
University Health Network, Toronto Canadian Anesthesiologists' Society |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00335582 |
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 | Intervention | Phase |
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Heart Disease |
Drug: clonidine hydrochloride |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 165 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meet >= 2of the following criteria:
Exclusion criteria: - if meets any of the following
Contact: Jo Carroll, RN | 416-340-4800 ext 3243 | jo.carroll@uhn.on.ca |
Canada, Ontario | |
Toronto General Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2C4 | |
Sub-Investigator: Scott Beattie, MD | |
Sub-Investigator: Keyvan Karkouti, MD | |
Sub-Investigator: Stuart McCluskey, MD | |
Sub-Investigator: Barry Rubin, MD |
Principal Investigator: | Duminda Wijeysundera, MD | Toronto General Hospital, University Health Network |
Responsible Party: | Toronto General Hospital, University Health Network ( Dr. Duminda Wijeysundera ) |
Study ID Numbers: | REB#05-0146-B |
Study First Received: | June 8, 2006 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00335582 History of Changes |
Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee |
alpha 2 agonists cardiac events non cardiac surgery |
Neurotransmitter Agents Adrenergic alpha-Agonists Heart Diseases Adrenergic Agents Clonidine Cardiovascular Agents |
Peripheral Nervous System Agents Analgesics Ischemia Antihypertensive Agents Adrenergic Agonists |
Sympatholytics Neurotransmitter Agents Heart Diseases Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Clonidine Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Adrenergic Agonists Pharmacologic Actions Autonomic Agents Sensory System Agents Therapeutic Uses Cardiovascular Diseases Analgesics Peripheral Nervous System Agents Central Nervous System Agents |