Trial · Interventional

TerminatedPhase 3Results postedRegistry data

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

Short name RED-CABG

NCTNCT00872001Other idP05633Other idMK-8395Other idRED-CABG

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

The registry gives no reason.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 3
Enrollment: 3,080 participants (actual)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Randomized · Quadruple masking
Countries: Not stated
Start: Apr 2009
Primary completion: Oct 2010
Completion: Oct 2010
First posted: 30 Mar 2009 (estimated)
Last update posted: 29 Oct 2015 (estimated)
Conditions: Coronary Artery Bypass · Myocardial Infarction · Ventricular Dysfunction, Left · Stroke · Cardiopulmonary Bypass

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200920102011

Ph 3
RED-CABG
NCT00872001
Apr 2009 to Oct 2010
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine whether acadesine is effective in reducing the cardiovascular and cerebrovascular adverse events in high-risk participants undergoing CABG surgery.

Interventions

AcadesineDrug
Normal SalineDrug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population)
Time frame · Up to Post-Operative Day 28
Registry description
Incidence of all-cause death, non-fatal stroke, or need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: All-cause death: Death from any cause, Non-fatal Stoke: occurrence of a stoke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.

Secondary outcomes(1)

Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population)
Time frame · Up to Post-Operative Day 28
Registry description
Incidence of cardiovascular death, non-fatal stroke, and need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: Cardiovascular death: Death due to cardiovascular causes, Non-fatal Stroke: occurrence of a stroke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Up to Post-Operative Day 28

Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population)

Group	Value (Percentage of Participants)
Acadesine	4.9
Placebo	4.9

Secondary and other outcome results(1)

Secondary outcomeNumber· Up to Post-Operative Day 28

Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population)

Group	Value (Percentage of Participants)
Acadesine	4.8
Placebo (Normal Saline)	4.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
AcadesineAcadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)	–	327 / 1442	1154 / 1442
Placebo (Normal Saline)Placebo (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	–	329 / 1457	1189 / 1457

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

Predictors of contemporary coronary artery bypass grafting outcomes.

Weisel et al. 2014The Journal of thoracic and cardiovascular surgerycited by 19

PMID 25218533DOI 10.1016/j.jtcvs.2014.08.018PUB-25218533

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 2012

2 results

Effect of adenosine-regulating agent acadesine on morbidity and mortality associated with coronary artery bypass grafting: the RED-CABG randomized controlled trial.

Newman et al. 2012JAMAcited by 43

PMID 22782417DOI 10.1001/jama.2012.7633PUB-22782417

Full text at the publisher2 results

Publisher page See results (2)

Eligibility

Who could join, as posted.

Sex: All
Age: from 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 * History of myocardial infarction (MI), or * History of ischemic stroke, or * Left ventricular ejection fraction \<=30%, or * Diabetes mellitus requiring insulin and/or antidiabetic agents. * Significant coronary artery stenosis Exclusion Criteria: * Planned valve replacement, carotid artery or aortic surgery, distal coronary endarterectomy,surgical ablation for cardiac arrhythmia, or ventricular aneurysmectomy, alone or with CABG surgery (repair for mild to moderate mitral valve disease with concomitant CABG is not excluded). * 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). * MI within 5 days prior to surgery. * Pre-operative or planned intra operative/postoperative use of intra-aortic balloon pump (IABP), ventricular assist device (VAD), extra-corporeal membrane oxygenator (ECMO), or other mechanical hemodynamic assist device. * History or presence of gout or uric acid nephrolithiasis. * Serum creatinine \>2 mg/dL (180 µmol/L). * Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 x Upper Limit of Normal (ULN). * Adenosine, aminophylline, nicotinic acid, pentoxifylline, theophylline, and any cardioplegia solution containing adenosine, dipyridamole or lidoflazine within 24 hours before surgery: * Dipyridamole within 2 days and allopurinol or febuxostat within 4 days before surgery * Food and drinks containing caffeine, theobromines or methylxanthines (such as coffee, tea, colas, some 'energy' drinks or chocolate) within 12 hours before surgery. * Pregnancy

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