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| Sponsor: | University Health Network, Toronto |
|---|---|
| Collaborator: |
Canadian Anesthesiologists' Society |
| Information provided by: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00335582 |
Purpose
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 |
|---|---|---|
|
Heart Disease |
Drug: clonidine hydrochloride |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 Study Completion Date: | December 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Eligibility| 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
Contacts and Locations| Canada, Ontario | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Principal Investigator: | Duminda Wijeysundera, MD | Toronto General Hospital, University Health Network |
More Information
| Responsible Party: | Dr. Duminda Wijeysundera, Toronto General Hospital, University Health Network |
| ClinicalTrials.gov Identifier: | NCT00335582 History of Changes |
| Other Study ID Numbers: | REB#05-0146-B |
| Study First Received: | June 8, 2006 |
| Last Updated: | October 8, 2009 |
| Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee |
|
alpha 2 agonists cardiac events non cardiac surgery |
|
Heart Diseases Ischemia Cardiovascular Diseases Pathologic Processes Clonidine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Central Nervous System Agents |