PeriOperative ISchemic Evaluation-2 Pilot

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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 surgery have been tested.

There is encouraging data suggesting that low-doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborators: Canadian Network and Centre for Trials Internationally; The Physicians' Services Incorporated Foundation
• Treatments: Clonidine

Criteria

Inclusion Criteria:

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:

1. undergoing major surgery [i.e., intraperitoneal, intrathoracic, or orthopedic surgery]

2. history of congestive heart failure

3. transient ischemic attack

4. diabetes and currently taking an oral hypoglycemic agent or insulin

5. age = or > than 70 years

6. hypertension

7. serum creatinine > 175 µmol/L

8. history of smoking within 2 years of surgery, or

9. undergoing emergent/urgent surgery

Exclusion Criteria:

• 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