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PeriOperative ISchemic Evaluation-2 Trial (POISE-2)

H

Hamilton Health Sciences (HHS)

Status and phase

Completed
Phase 3

Conditions

Cardiovascular Disease

Treatments

Drug: Active Clonidine
Drug: Placebo ASA
Drug: Active ASA
Drug: Placebo Clonidine

Study type

Interventional

Funder types

Other

Identifiers

NCT01082874
POISE-2 01MAR2010
2009-018173-31 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10,010 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

10,010 participants in 4 patient groups, including a placebo group

Active Clonidine and Active ASA
Experimental group
Treatment:
Drug: Active ASA
Drug: Active Clonidine
Active Clonidine and Placebo ASA
Experimental group
Treatment:
Drug: Placebo ASA
Drug: Active Clonidine
Placebo Clonidine and Active ASA
Experimental group
Treatment:
Drug: Placebo Clonidine
Drug: Active ASA
Placebo Clonidine and Placebo ASA
Placebo Comparator group
Treatment:
Drug: Placebo Clonidine
Drug: Placebo ASA

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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