EPIC (Evaluating Perioperative Ischemia Reduction by Clonidine)
Information source: University Health Network, Toronto
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Disease
Intervention: clonidine hydrochloride (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s):
Duminda Wijeysundera, MD, Principal Investigator, Affiliation: Toronto General Hospital, University Health Network
Overall contact:
Jo Carroll, RN, Phone: 416-340-4800, Ext: 3243, Email: jo.carroll@uhn.on.ca
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.
Clinical Details
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 design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jo Carroll, RN, Phone: 416-340-4800, Ext: 3243, Email: jo.carroll@uhn.on.ca
Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada; Recruiting
Scott Beattie, MD, Sub-Investigator
Keyvan Karkouti, MD, Sub-Investigator
Stuart McCluskey, MD, Sub-Investigator
Barry Rubin, MD, Sub-Investigator
Additional Information
Starting date: June 2006
Last updated: May 22, 2008
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