PeriOperative ISchemic Evaluation-2 Trial
Research type
Research Study
Full title
A large, international, placebo-controlled, factorial trial to assess the impact of low-dose clonidine and acetyl-salicyclic acid (ASA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event. PeriOperative ISchemic Evaluation-2 Trial.
IRAS ID
66725
Contact name
Balaji Packianathaswamy
Sponsor organisation
Population Health Research Institute
Eudract number
2009-018173-31
ISRCTN Number
ISRCTN17233551
Clinicaltrials.gov Identifier
Research summary
During the last few decades, substantial advances in noncardiac surgery have improved disease treatment and patients?? quality of life. As a result, the number of patients undergoing noncardiac surgery is growing. A recent study that used surgical data from 56 countries suggests that 200 million major noncardiac surgical procedures are undertaken annually around the world. Noncardiac surgery is associated with major vascular complications (i.e., vascular death, nonfatal myocardial infarction [MI], nonfatal cardiac arrest, and nonfatal stroke). Worldwide, approximately 3-5 million adult patients annually suffer a major perioperative vascular complication in the first 30 days after surgery. There is not a single established effective and safe intervention to prevent major perioperative vascular complications. The striking absence of prophylactic interventions reflects the paucity of large randomized controlled trials (RCTs) evaluating perioperative interventions. Major perioperative vascular complications are therefore a major neglected public health problem. There are encouraging laboratory, physiology, operative and non-operative data suggesting that perioperative low-dose clonidine and low-dose acetyl-salicylic acid (ASA) may prevent all-cause mortality and nonfatal MI without excessive risk of major bleeding and clinically important hypotension. We will undertake a large international factorial RCT to establish the effects of these 2 interventions in patients undergoing noncardiac surgery.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
10/H1306/85
Date of REC Opinion
8 Feb 2011
REC opinion
Further Information Favourable Opinion