Trials / Terminated
TerminatedNCT00872001
The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633 AM1)(TERMINATED)
The Effect Of Acadesine On Clinically Significant Adverse Cardiovascular and Cerebrovascular Events In High-Risk Subjects Undergoing Coronary Artery Bypass Graft (CABG) Surgery Using Cardiopulmonary Bypass (Protocol No. P05633): RED-CABG Trial (Reduction in Cardiovascular Events by AcaDesine in Subjects Undergoing CABG)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3,080 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Coronary Artery Bypass
- Myocardial Infarction
- Ventricular Dysfunction, Left
- Stroke
- Cardiopulmonary Bypass
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acadesine | Acadesine 42 mg/kg diluted in normal saline to a total of 500 mL, delivered as an IV infusion over approximately 7 hours commencing within approximately 30 minutes before induction of anesthesia at a rate of 0.1 mg/kg/min (translating into 1.2 mL/min for a 500 mL solution). In addition, a 5 µg/mL cardioplegia solution of acadesine will be administered, and acadesine will be added to the priming solution (5 µg/mL) in the heart lung machine during CPB. |
| DRUG | Normal Saline | Normal saline, 500 mL delivered as an IV infusion over approximately 7 hours commencing within approximately 30 minutes before induction of anesthesia at a rate of 1.2 mL/min for a 500 mL solution. In addition, standard cardioplegia solution with added normal saline will be administered, and placebo (normal saline) will also be added to the heart lung machine priming solution. |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2010-10-01
- Completion
- 2010-10-01
- First posted
- 2009-03-30
- Last updated
- 2015-10-29
- Results posted
- 2012-12-20
Source: ClinicalTrials.gov record NCT00872001. Inclusion in this directory is not an endorsement.