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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
Sponsor:
Collaborator:
Canadian Anesthesiologists' Society
Information provided by:
University Health Network, Toronto

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : June 2006
Actual Primary Completion Date : August 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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)


Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 45 years
  2. Current use of b-blocker therapy>=30 days prior to surgery
  3. Undergoing non-cardiac surgery with an expected length of stay ≥ 48 hours for medical reasons
  4. Informed consent
  5. Undergoing major vascular surgery (excluding carotid endarterectomy, dialysis shunt, and vein stripping) OR

Meet >= 2of the following criteria:

  1. Coronary artery disease
  2. Congestive heart failure
  3. Stroke or transient ischemic attack
  4. Diabetes mellitus requiring oral hypoglycemic or insulin therapy
  5. Preoperative renal insufficiency (creatinine clearance below 60 mL/min)
  6. Peripheral vascular disease, as defined by any of the following: history of ischemic intermittent claudication or rest pain, history of revascularization procedure to legs, peripheral arterial obstruction of >= 50% luminal diameter
  7. Age >=70 years
  8. Intermediate-risk surgical procedure: intra-peritoneal, intra-thoracic, carotid endarterectomy, major orthopedic (hip, knee, spine) surgery, radical prostatectomy, or head-and-neck surgery

Exclusion criteria: - if meets any of the following

  1. Prior adverse reaction to clonidine or a-2 agonists
  2. Current use of Clonidine or a-2 agonists
  3. Current congestive heart failure
  4. Only b-blocker taken by patient is sotalol
  5. Left ventricular ejection fraction <=40%
  6. Systolic blood pressure < = 90 mmHg
  7. Concomitant life-threatening disease likely to limit life expectancy to <=30 days.
  8. Clinically significant aortic stenosis, defined as an aortic valve area <=1.0 cm2 and/or peak trans-valvular pressure gradient >= 25 mmHg

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Canadian Anesthesiologists' Society
Investigators
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Principal Investigator: Duminda Wijeysundera, MD Toronto General Hospital, University Health Network

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
First Posted: June 12, 2006    Key Record Dates
Last Update Posted: October 9, 2009
Last Verified: May 2009
Keywords provided by University Health Network, Toronto:
alpha 2 agonists
cardiac events
non cardiac surgery
Additional relevant MeSH terms:
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Heart Diseases
Ischemia
Cardiovascular Diseases
Pathologic Processes
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action