Status:
COMPLETED
PeriOperative ISchemic Evaluation-2 Pilot
Lead Sponsor:
McMaster University
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Canadian Network and Centre for Trials Internationally
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
45+ years
Phase:
PHASE4
Brief Summary
Major non-cardiac surgeries are common and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of ...
Detailed Description
The POISE-2 Pilot Trial will provide the essential remaining feasibility data that POISE-2 researchers require prior to conducting a large international study to test the effect of ASA and Clonidine i...
Eligibility Criteria
Inclusion
- Patients undergoing noncardiac surgery who fulfill the following criteria:
- age ≥ 45 years
- expected to require at least an overnight hospital admission after noncardiac surgery, and fulfill any 1 of the following criteria:
- history of coronary artery disease
- peripheral vascular disease
- stroke
- undergoing major vascular surgery (i.e., vascular surgery except arteriovenous shunt, vein stripping procedures, and carotid endarterectomies)
- OR any 3 of 9 risk criteria:
- undergoing major surgery \[i.e., intraperitoneal, intrathoracic, or orthopedic surgery\]
- history of congestive heart failure
- transient ischemic attack
- diabetes and currently taking an oral hypoglycemic agent or insulin
- age = or \> than 70 years
- hypertension
- serum creatinine \> 175 µmol/L
- history of smoking within 2 years of surgery, or
- undergoing emergent/urgent surgery
Exclusion
- Patients has taken ASA \< or = to 72 hours before scheduled surgery
- history of ASA or clonidine hypersensitivity or allergy
- systolic blood pressure \< 105 mm Hg
- heart rate \< 55 beats per minute
- second or third degree heart block without a pacemaker
- patient has active peptic ulcer disease
- Patient has had a bare metal stent in the six weeks prior to randomization
- Patient has had a drug eluting stent in the year prior to randomization
- Patient is currently taking an alpha-2 agonist, alpha methyldopa, reserpine, clopidogrel, or ticlopidine
- Patient undergoing intracranial surgery, carotid endarterectomy, or retinal surgery
- Surgeon unwilling to have patient participate in a participate in a perioperative clonidine/ASA trial
- Prior enrolment in the POISE-2 pilot trial
- Unable to obtain or refusal to consent prior to surgery
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00860925
Start Date
May 1 2009
End Date
January 1 2010
Last Update
March 9 2010
Active Locations (4)
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1
Walter C MacKenzie Health Sciences
Edmonton, Alberta, Canada, T6G 2B7
2
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
3
St Joseph's Health Sciences
Hamilton, Ontario, Canada, L8N 4A6
4
Prince of Wales Hospital
Hong Kong, China