Overview

This trial is active, not recruiting.

Condition heart disease
Treatment clonidine hydrochloride
Phase phase 4
Sponsor University Health Network, Toronto
Collaborator Canadian Anesthesiologists' Society
Start date June 2006
End date August 2009
Trial size 165 participants
Trial identifier NCT00335582, REB#05-0146-B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 45 years old.

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

Additional Information

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.
Principal investigator Duminda Wijeysundera, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.