Phase 3
Completed N=10,010
PeriOperative ISchemic Evaluation-2 Trial
Source: ClinicalTrials.gov NCT01082874 ↗Enrolled (actual)
10,010
Serious AEs
1.8%
Results posted
Aug 2016
Primary outcomePrimary: Composite of All-cause Mortality and Nonfatal MI — 173; 194; 178; 161 participants
◆ Published Evidence
Highly cited
933citations · ~78 / year
Aspirin in patients undergoing noncardiac surgery.
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.
Linked Publications (5)
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Aspirin in patients undergoing noncardiac surgery.
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Clonidine in patients undergoing noncardiac surgery.
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Aspirin and clonidine in non-cardiac surgery: acute kidney injury substudy protocol of the Perioperative Ischaemic Evaluation (POISE) 2 randomised controlled trial.
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Relative contributions of anaemia and hypotension to myocardial infarction and renal injury: Post hoc analysis of the POISE-2 trial.
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Preoperative estimated glomerular filtration rate to predict cardiac events in major noncardiac surgery: a secondary analysis of two large international studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of All-cause Mortality and Nonfatal MI |
173; 194; 178; 161 | — |
| PRIMARY All-cause Mortality and Nonfatal MI |
— | — |
| SECONDARY Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke |
— | — |
| SECONDARY Individual Secondary Outcomes |
— | — |
| SECONDARY Composite Outcome by ASA Stratum |
— | — |
| SECONDARY Safety Outcomes in ASA Trial |
— | — |
| SECONDARY Safety Outcomes in Clonidine Trial |
— | — |
| SECONDARY Composite Outcome at 1 Year |
— | — |
| SECONDARY Individual Secondary Outcomes at 1 Year |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01082874) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.