EPIC (Evaluating Perioperative Ischemia Reduction by Clonidine) - Full Text View

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

MedlinePlus related topics:

Heart Attack Heart Diseases

ChemIDplus related topics:

Clonidine Clonidine hydrochloride

U.S. FDA Resources

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.

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	165
Study Start Date:	June 2006
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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)

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Meet >= 2of the following criteria:

Coronary artery disease
Congestive heart failure
Stroke or transient ischemic attack
Diabetes mellitus requiring oral hypoglycemic or insulin therapy
Preoperative renal insufficiency (creatinine clearance below 60 mL/min)
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
Age >=70 years
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335582

Contacts


Contact: Jo Carroll, RN	416-340-4800 ext 3243	jo.carroll@uhn.on.ca

Locations


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

Sponsors and Collaborators

University Health Network, Toronto

Canadian Anesthesiologists' Society

Investigators


Principal Investigator:	Duminda Wijeysundera, MD	Toronto General Hospital, University Health Network

More Information

Responsible Party:	Toronto General Hospital, University Health Network ( Dr. Duminda Wijeysundera )
Study ID Numbers:	REB#05-0146-B
First Received:	June 8, 2006
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00335582
Health Authority:	Canada: Health Canada; Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

alpha 2 agonists

cardiac events

non cardiac surgery

Study placed in the following topic categories:

Heart Diseases

Clonidine

Ischemia

Additional relevant MeSH terms:

Sympatholytics

Neurotransmitter Agents

Adrenergic alpha-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

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

ClinicalTrials.gov processed this record on October 14, 2008

Sponsors and Collaborators:	University Health Network, Toronto Canadian Anesthesiologists' Society
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00335582