PeriOperative ISchemic Evaluation-2 Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT01082874

Run by

Hamilton Health Sciences Corporation

People needed

10010

Starts

2010-07-01

Expected to finish

2015-01-01

Last updated by the study team

2016-08-25

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are undergoing noncardiac surgery;
• Are ≥ 45 years of age;
• Are expected to require at least an overnight hospital admission after surgery; AND
• 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

You may not qualify if…

• Consumption of ASA within 72 hours prior to surgery
• Hypersensitivity or known allergy to ASA or clonidine
• Systolic blood pressure < 105 mm Hg
• Heart rate < 55 beats per minute in a patient who does not have a permanent pacemaker
• Second or third degree heart block without a permanent pacemaker
• Active peptic ulcer disease or gastrointestinal bleeding within previous 6 weeks
• 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
• 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
• Drug-eluting coronary stent in the year prior to randomization
• Bare-metal coronary stent in the 6 weeks prior to randomization
• 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;
• Planned use - during the first 3 days after surgery - therapeutic dose anticoagulation or a therapeutic subcutaneous or intravenous antithrombotic agent
• Undergoing intracranial surgery, carotid endarterectomy, or retinal surgery
• Not consenting to participate in POISE-2 prior to surgery
• Previously enrolled in POISE-2 Trial

Where it is running

• National Coordination Office — Cleveland, Ohio, United States
• National Coordination Office — Rosario, Argentina
• National Coordination Office Australia and New Zealand — Parkville, Victoria, Australia
• National Coordination Office — Vienna, Austria
• National Coordination Office — Brussels, Belgium
• National Coordination Office — São Paulo, Brazil
• National Coordination Office — Hamilton, Ontario, Canada
• National Coordination Office — Santiago, Chile
• National Coordination Office — Bucamaranga, Colombia
• National Coordination Office — Herlev, Denmark
• National Coordination Office — Boulogne-Billancourt, France
• National Coordination Office — Bonn, Germany
• National Coordination Office — Hong Kong, Hong Kong
• National Coordination Office — Bangalore, India
• National Coordination Office — Milan, Italy
• National Coordination Office — Kuala Lumpur, Malaysia
• National Coordination Office — Auckland, New Zealand
• National Coordination Office — Islamabad, Pakistan
• National Coordination Office — Lima, Peru
• National Coordination Office — Durban, South Africa
• National Coordination Office — Barcelona, Spain
• National Coordination Office — Basel, Switzerland
• National Coordination Office — Hull, United Kingdom

Full record on ClinicalTrials.gov

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