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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
10,010
Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
National Coordination Office
Cleveland, Ohio, United States
National Coordination Office
Rosario, Argentina
National Coordination Office Australia and New Zealand
Parkville, Victoria, Australia
National Coordination Office
Vienna, Austria
National Coordination Office
Brussels, Belgium
National Coordination Office
São Paulo, Brazil
National Coordination Office
Hamilton, Ontario, Canada
National Coordination Office
Santiago, Chile
National Coordination Office
Bucamaranga, Colombia
National Coordination Office
Herlev, Denmark
...and 13 more locations
Composite of All-cause Mortality and Nonfatal MI
Time frame: 30 days
All-cause Mortality and Nonfatal MI
Time frame: 1 year
Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke
Time frame: 30 days
Individual Secondary Outcomes
All-cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, pulmonary emboli, deep venous thrombosis, clinically important atrial fibrillation, amputation, peripheral arterial thrombosis, infection/sepsis, rehospitalization for vascular reasons, length of hospital stay, length of intensive care unit / cardiac care unit (ICU/CCU) stay, and new acute renal failure requiring dialysis.
Time frame: 30 days
Composite Outcome by ASA Stratum
Composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis.
Time frame: 30 days
Safety Outcomes in ASA Trial
Stroke, congestive heart failure, life-threatening bleeding, and major bleeding.
Time frame: 30 days
Safety Outcomes in Clonidine Trial
Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure.
Time frame: 30 days
Composite Outcome at 1 Year
All-cause mortality, nonfatal MI, and nonfatal stroke.
Time frame: 1 year
Individual Secondary Outcomes at 1 Year
All cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, stroke, pulmonary emboli, deep venous thrombosis, amputation, peripheral arterial thrombosis, new diagnosis of cancer, diagnosis of recurrent cancer and rehospitalization for vascular reason.
Time frame: 1 year
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