PeriOperative ISchemic Evaluation-2 Trial

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Major surgeries not involving the heart 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 small 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. The POISE-2 Trial is a large international study to test if ASA and Clonidine can prevent heart attacks and deaths from heart problems around the time of surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborator: McMaster University
• Treatments: Aspirin; Clonidine; Salicylates; Salicylic Acid

Criteria

Inclusion Criteria:

1. Are undergoing noncardiac surgery;

2. Are ≥ 45 years of age;

3. Are expected to require at least an overnight hospital admission after surgery; AND

4. Fulfill one or more of the following 5 criteria:

• History of coronary artery disease

• History of peripheral vascular disease

• History of stroke

• Undergoing major vascular surgery

• Any 3 of the following 9 criteria:

• undergoing major surgery (i.e. intraperitoneal, intrathoracic, retroperitoneal or major orthopedic surgery

• history of congestive heart failure

• transient ischemic attack

• diabetes and currently taking an oral hypoglycemic agent or insulin

• age ≥ 70 years

• hypertension

• serum creatinine > 175 µmol/L (> 2.0 mg/dL)

• history of smoking within 2 years of surgery

• undergoing urgent/emergent surgery

Exclusion Criteria:

1. Consumption of ASA within 72 hours prior to surgery

2. Hypersensitivity or known allergy to ASA or clonidine

3. Systolic blood pressure < 105 mm Hg

4. Heart rate < 55 beats per minute in a patient who does not have a permanent pacemaker

5. Second or third degree heart block without a permanent pacemaker

6. Active peptic ulcer disease or gastrointestinal bleeding within previous 6 weeks

7. Intracranial hemorrhage documented by neuro-imaging, in the 6 months prior to randomization. This does not include petechial hemorrhagic transformation of a primary ischemic stroke

8. Subarachnoid hemorrhage or epidural hematoma unless the event occurred more than 6 months prior to randomization and the offending aneurysm or arterial lesion has been repaired

9. Drug-eluting coronary stent in the year prior to randomization

10. Bare-metal coronary stent in the 6 weeks prior to randomization

11. Thienopyridine (e.g., clopidogrel, ticlopidine, prasugrel) or ticagrelor within 72 hours prior to surgery; or intent to restart a thienopyridine or ticagrelor during the first 7 days post-op; or currently taking an alpha-2 agonist, alpha methyldopa, monoamine oxidase inhibitors or reserpine;

12. Planned use - during the first 3 days after surgery - therapeutic dose anticoagulation or a therapeutic subcutaneous or intravenous antithrombotic agent

13. Undergoing intracranial surgery, carotid endarterectomy, or retinal surgery

14. Not consenting to participate in POISE-2 prior to surgery

15. Previously enrolled in POISE-2 Trial