Heart DiseasePhase 4NCT00335582
EPIC (Evaluating Perioperative Ischemia Reduction by Clonidine)
A Phase 4 study testing clonidine hydrochloride in people with Heart Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Heart Disease
- What is being tested?
- clonidine hydrochloride
- Type of treatment
- Pill or oral medicine
- How many people
- 165 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2006to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
- Conditions
- Heart Disease
- Being tested
- clonidine hydrochloride
- Keywords
- alpha 2 agonists, cardiac events, non cardiac surgery
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonidine hydrochlorideDrug
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Daily until discharge and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2009
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society
- Investigators
- Duminda Wijeysundera, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335582
- Sponsor's protocol ID
- REB#05-0146-B
- Status last verified
- May 2009
- First submitted
- 8 Jun 2006
- Last updated
- 9 Oct 2009
- Results posted
- No
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.
PubMed 25189430
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00335582
- Acronym / sponsor ID
- REB#05-0146-B
- Conditions
- Heart Disease
- Keywords
- alpha 2 agonists, cardiac events, non cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society
- Study start
- Jun 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 12 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (8 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clonidine hydrochlorideOne 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) | Drug | – |
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
Time frame: Daily until discharge and 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2009.
- Derived from this study: PubMed 25189430Wijeysundera 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duminda Wijeysundera, MD principal investigator
Toronto General Hospital, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clonidine hydrochloride in people with Heart Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00335582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2009.