The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633 AM1)(TERMINATED)

Plain-language guide to NCT00872001: phase 3 randomized trial of AICAR, 3080 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00872001
Phase: phase 3
Status: terminated early
Start: 2009-04
Completion (planned or actual): 2010-10
Participants: 3080 (actual)
Design: randomized, quadruple-blind, prevention
Conditions studied: Coronary Artery Bypass; Myocardial Infarction; Ventricular Dysfunction, Left; Stroke; Cardiopulmonary Bypass
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested AICAR.

It had two arms (groups): Acadesine (active comparator) and Placebo (placebo comparator).

Acadesine intravenous (IV) infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB).

Normal saline, IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB.

The registry classes the interventions as drug.

Who Took Part

The registry lists 3080 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: A high risk participant undergoing non emergency CABG surgery requiring CPB and cardioplegia. Age: \>=50 years. At least one of the following risk factors:. Female (but not pregnant or lactating), or. History of prior CABG, or.

The full record lists 10 inclusion and 13 exclusion criteria; among the exclusions: planned or staged major surgery within 30 days of cabg surgery; CABG surgery using intermittent aortic cross clamping without cardioplegia; minimally invasive surgery (ie, without use of cpb).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the AICAR group and the comparison group should start out alike.

The AICAR group and the comparison group ran side by side rather than switching.

As a double-blind AICAR study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-04 with completion listed for 2010-10.

Its stated primary purpose is prevention.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of AICAR in 3080 people.

With 3080 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the AICAR compound page, all human trials.

Our Notes on the Compound

AICAR: A research compound that activates AMPK, nicknamed the “exercise pill”; prohibited in sport and not approved for human use.

AICAR in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.