None listed
Conditions
Interventions
Group 1 Type of group
Clonidine: 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.
Aspirina: 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
Group name:Group 4 Type of group
Clonidine Placebo: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Aspirin Placebo: 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
Sponsors
POPULATION HEALTH RESEARCH INSTITUTE DE LA UNIVERSIDAD MC MASTER DE CANADA,
Eligibility
Sex/Gender
All
Age
45 Years to 90 Years
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: o History of coronary artery disease o History of peripheral vascular disease o History of stroke o Undergoing major vascular surgery o 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Record of deaths from all causes and myocardial infarction occurred during the study. Measure:Composite of All-cause Mortality and Nonfatal MI Timepoints:30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis Measure:Composite Outcome by ASA Stratum Timepoints:30 days ; Outcome name:Stroke, congestive heart failure, life-threatening bleeding, and major bleeding. Measure:Safety Outcomes in ASA Trial Timepoints:30 days ; Outcome name:Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure. Measure:Safety Outcomes in Clonidine Trial Timepoints:30 days ; Outcome name:All-cause mortality, nonfatal MI, and nonfatal stroke. Measure:Composite Outcome at 1 Year Timepoints:1 Year ; Outcome name: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. Measure:Individual Secondary Outcomes at 1 Year Timepoints:1 year | — |
Countries
Bulgaria, Chile, Germany, Hungaria, Mexico, Peru, Poland, Romania, Spain, United States
Contacts
Public ContactGERMAN MALAGA
PREVI-MED S.A.C
Outcome results
None listed