PeriOperative ISchemic Evaluation-2 Trial

Summary

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.

Conditions

• Cardiovascular Disease

Interventions

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

Sponsors & Collaborators

• McMaster University

  collaborator OTHER

• Hamilton Health Sciences Corporation

  lead OTHER

Principal Investigators

• P.J. Devereaux, MD, PhD · Population Health Research Institute

• Salim Yusuf, DPhil · Population Health Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2014-03-31

Completion

2015-01-31

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Canada
• Chile
• Colombia
• Denmark
• France
• Germany
• Hong Kong
• India
• Italy
• Malaysia
• New Zealand
• Pakistan
• Peru
• South Africa
• Spain
• Switzerland
• United Kingdom

Study Locations