perioperative ischemic evaluation-2 trial

Conditions: Cardiovascular Disease

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.

poise-2 is a multicentre, international, blinded, 2x2 factorial randomized controlled trial of acetyl-salicylic acid (asa) and clonidine. the primary objective is to determine the impact of clonidine versus placebo and asa versus placebo on the 30-day risk of all-cause mortality or nonfatal myocardial infarction in patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. patients in the poise-2 trial will be randomly assigned to one of four groups: asa and clonidine together, asa and clonidine placebo, asa placebo and clonidine, or a asa placebo and clonidine placebo. research personnel will follow patients at 30 days post-randomization and 1 year post-randomization.

Eligibility 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

Keywords: randomized controlled trial blinded clonidine acetyl-salicylic acid (asa) perioperative vascular complications noncardiac surgery