Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 45 YearsSexo: ALL

Criterios de inclusión

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
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

Criterios de exclusión

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
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;
Planned use - during the first 3 days after surgery - therapeutic dose anticoagulation or a therapeutic subcutaneous or intravenous antithrombotic agent
Undergoing intracranial surgery, carotid endarterectomy, or retinal surgery
Not consenting to participate in POISE-2 prior to surgery
Previously enrolled in POISE-2 Trial

Intervenciones

drug

Active 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.

drug

Placebo Clonidine

Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.

drug

Active ASA

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

drug

Placebo ASA

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

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

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Active Clonidine

Placebo Clonidine

Active ASA

Placebo ASA

Ubicaciones

National Coordination Office

Patrocinadores