PeriOperative ISchemic Evaluation-2 Trial
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 1/1/2014 |
| Start Date: | July 2010 |
| End Date: | December 2014 |
| Contact: | Andrea Robinson, BSc |
| Email: | poise2@phri.ca |
| Phone: | +1-905-527-4322 |
A Large, International, Placebo-controlled, Factorial Trial to Assess the Impact of Clonidine and Acetyl-salicylic Acid (ASA) in Patients Undergoing Noncardiac Surgery Who Are at Risk of a Perioperative Cardiovascular Event
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.
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.
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.
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
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