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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

Tracking Information
First Submitted Date  ICMJE June 8, 2006
First Posted Date  ICMJE June 12, 2006
Last Update Posted Date October 9, 2009
Study Start Date  ICMJE June 2006
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00335582 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EPIC (Evaluating Perioperative Ischemia Reduction by Clonidine)
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Heart Disease
Intervention  ICMJE 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)
Study Arms  ICMJE Not Provided
Publications * Wijeysundera DN, Choi PT, Badner NH, Brasher PM, Dresser GK, Delgado DH, Beattie WS. A randomized feasibility trial of clonidine to reduce perioperative cardiac risk in patients on chronic beta-blockade: the EPIC study. Can J Anaesth. 2014 Nov;61(11):995-1003. doi: 10.1007/s12630-014-0226-6. Epub 2014 Sep 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 22, 2008)
165
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00335582
Other Study ID Numbers  ICMJE REB#05-0146-B
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Duminda Wijeysundera, Toronto General Hospital, University Health Network
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Canadian Anesthesiologists' Society
Investigators  ICMJE
Principal Investigator: Duminda Wijeysundera, MD Toronto General Hospital, University Health Network
PRS Account University Health Network, Toronto
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP