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) - RED-CABG Trial
- Conditions
- Coronary artery diseaseMedDRA version: 9.1 Level: LLT Classification code 10011078 Term: Coronary artery disease
- Registration Number
- EUCTR2008-004881-16-DE
- Lead Sponsor
- Schering-Plough Research Institute, a Division of Schering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 7500
The subject must meet ALL the criteria listed below for entry:
1. A subject must be a high-risk patient undergoing non-emergency CABG surgery requiring cardiopulmonary bypass and cardioplegia.
2. A subject must be = 50 years of age.
3. A subject must have at least one of the following risk factors:
a. Female (but not pregnant or lactating), or
b. History of prior CABG, or
C. History of MI (except for MI within 5 days prior to surgery or MI having occurred more than 2 years previously), or
d. History of ischemic stroke, or
e. Left ventricular ejection fraction (LVEF)=30% (measured any time within the previous 3 months before Screening by any clinically acceptable imaging modality), or
f. Diabetes mellitus requiring insulin and/or antidiabetic agents.
4. A subject must have demonstrated on coronary angiography, performed within the past 12 months, to have significant coronary artery stenosis of at least 50% of the left main coronary artery, or 70% or more of three coronary arteries, or 70% or more of two coronary arteries inclusive of the left anterior descending (LAD). The screening coronary angiography must have been performed after any previous PCI or CABG.
5. A subject must be willing and able to give Informed Consent.
6. A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception during screening and for one month after stopping the medication.
Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), inert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation).
Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period.
7. While participation in pharmacogenomic and biomarker testing is optional, a subject must be willing to give written informed consent for pharmacogenomic and biomarker testing in order for the tests to be performed. A subject who is unwilling to sign the informed consent for pharmacogenomic testing may be included in the trial; however, pharmacogenomic and biomarker samples must not be obtained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
The subject will be excluded from entry if ANY of the criteria listed below are met:
1. Subject undergoing 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).
2. Subject with planned or staged major surgery within 30 days of CABG surgery (eg, aortic aneurysm, abdominal, thoracic).
3. Subject undergoing CABG surgery using intermittent aortic cross clamping without cardioplegia.
4. Subject undergoing minimally invasive surgery (ie, without use of cardiopulmonary bypass).
5. Subject with an MI within 5 days prior to surgery.
6. Subject with a 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.
7. Subjects with a history or presence of gout or uric acid nephrolithiasis.
8. Subjects with a serum creatinine >2 mg/dL (180 umol/L) at Screening.
9. Subjects with a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 X Upper Limit of Normal (ULN) at Screening.
10. Subject who has received any treatment listed in Table 2 (Prohibited medications for Entry into the Study) in the protocol more recently than the indicated washout period prior to surgery or must continue to receive treatment that is listed in Table 2. (Prohibited medications: 12 hour washout period prior to surgery for caffeine; 24 hr washout period prior to surgery for adenosine, aminophylline, nicotinic acid, pentoxifylline, theophylline, and cardioplegia solutions containing adenosine, dipyridamole, or lidoflazine; 2 day washout period prior to surgery for dipyridamole; 4 day washout period prior to surgery for allopurinol or febuxostat; 30 day washout period prior to Screening for investigational drugs)
11. Administration of food and drinks containing caffeine, theobromines or methylxanthines (such as coffee, tea, colas, some 'energy' drinks or chocolate) is not allowed within 12 hours before surgery.
12. Subjects with known allergy/sensitivity to acadesine or its/their excipients.
13. Woman who is breast-feeding, pregnant or intends to become pregnant within 30 days of study drug administration.
14. Subject who has used any investigational drugs within 30 days of Screening.
15. Subject who is participating in any other interventional clinical study
(noninterventional observational studies (eg, registry studies) are allowed).
16. Subject who is part of the staff personnel directly involved with this study or who is a family member of the investigational study staff.
17. Subject with an inability or unwillingness to abide by the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method