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EPIC (Evaluating Perioperative Ischemia Reduction by Clonidine)

Primary Purpose

Heart Disease

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
clonidine hydrochloride
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Disease focused on measuring alpha 2 agonists, cardiac events, non cardiac surgery

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto General Hospital

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
June 8, 2006
Last Updated
October 8, 2009
Sponsor
University Health Network, Toronto
Collaborators
Canadian Anesthesiologists' Society
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1. Study Identification

Unique Protocol Identification Number
NCT00335582
Brief Title
EPIC (Evaluating Perioperative Ischemia Reduction by Clonidine)
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 Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Canadian Anesthesiologists' Society

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
alpha 2 agonists, cardiac events, non cardiac surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
clonidine hydrochloride
Intervention Description
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duminda Wijeysundera, MD
Organizational Affiliation
Toronto General Hospital, University Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25189430
Citation
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.
Results Reference
derived

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EPIC (Evaluating Perioperative Ischemia Reduction by Clonidine)

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