Health Condition 1: null- Cardiovascular diseasePerioperative Ischemia
Conditions
Interventions
Intervention1: Active Clonidine and Active ASA
Interventions:
Drug: Active Clonidine
Drug: Active ASA
: Drug: Active Clonidine
Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch
Sponsors
Population Health Research Institute
Eligibility
Inclusion criteria
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: 1. History of coronary artery disease 2. History of peripheral vascular disease 3. History of stroke 4. Undergoing major vascular surgery 5. Has any 3 of the following 9 criteria: 1. Undergoing major surgery (i.e.intraperitoneal, intrathoracic, or 2. major orthopedic surgery, 3. history of congestive heart failure, transient ischemic attack 4. diabetes and currently taking an oral hypoglycemic agent or insulin 5. age above 70 years 6. hypertension 7. serum creatinine > 175 µmol/L ( > 2.0 mg/dL) 8. history of smoking within 2 years of surgery 9. undergoing urgent/emergent surgery
Exclusion criteria
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 4.Heart rate 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.Currently taking an alpha-2 agonist, alpha methyldopa, reserpine, ticagrelor, or thienopyridine 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality and nonfatal MITimepoint: 1 year;All-cause mortality and nonfatal MITimepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite outcome at 1 year All-cause mortality, nonfatal MI, and nonfatal stroke.Timepoint: 1 year;Composite outcome by ASA stratum Composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis.Timepoint: 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, 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.Timepoint: 30 days;Individual secondary outcomes at 1 year All cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, stroke, pulmonary emboli, deep venous thrombosis, and rehospitalization for vascular reason.Timepoint: 1 year;Safety outcomes in ASA trial Stroke, congestive heart failure, life-threatening bleeding, and major bleeding.Timepoint: 30 days;Safety outcomes in clonidine trial Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failureTimepoint: 30 days;Composite of all-cause mortality, nonfatal MI, and nonfatal strokeTimepoint: 30 days | — |
Countries
Australia, Austria, Belgium, Canada, Chile, Colombia, Denmark, Hong Kong, Italy, Pakistan, Peru, South Africa, Spain, United States of America
Contacts
Public ContactDr Denis Xavier
Professor
Outcome results
None listed