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
Overview
- Phase
- Phase 3
- Intervention
- Active Clonidine
- Conditions
- Cardiovascular Disease
- Sponsor
- Hamilton Health Sciences Corporation
- Enrollment
- 10010
- Locations
- 2
- Primary Endpoint
- All-cause Mortality and Nonfatal MI
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Detailed 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.
Investigators
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
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
Arms & Interventions
Active Clonidine and Active ASA
Intervention: Active Clonidine
Active Clonidine and Active ASA
Intervention: Active ASA
Active Clonidine and Placebo ASA
Intervention: Active Clonidine
Active Clonidine and Placebo ASA
Intervention: Placebo ASA
Placebo Clonidine and Active ASA
Intervention: Placebo Clonidine
Placebo Clonidine and Active ASA
Intervention: Active ASA
Placebo Clonidine and Placebo ASA
Intervention: Placebo Clonidine
Placebo Clonidine and Placebo ASA
Intervention: Placebo ASA
Outcomes
Primary Outcomes
All-cause Mortality and Nonfatal MI
Time Frame: 1 year
Composite of All-cause Mortality and Nonfatal MI
Time Frame: 30 days
Secondary Outcomes
- Composite Outcome by ASA Stratum(30 days)
- Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke(30 days)
- Safety Outcomes in Clonidine Trial(30 days)
- Individual Secondary Outcomes at 1 Year(1 year)
- Safety Outcomes in ASA Trial(30 days)
- Individual Secondary Outcomes(30 days)
- Composite Outcome at 1 Year(1 year)