Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
10,010 participants in 4 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal