The study population will be selected from both genders with coronary artery disease (CAD) who are to undergo cardiopulmonary bypass for coronary artery bypass surgery. The ratio of incidence for bypass surgery in the population is 4:1 (men:women) and reflects the normal allocation/distribution of cases of the disease in the population. MedDRA version: 14.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: Custodiol-N®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Sodium chloride
Concentration unit: mmol/l millimole(s)/litre
Concentration type: equal
Concentration number:
Sponsors
Dr. F. Köhler Chemie GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients >/=35 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) Patients undergoing valve repair or replacement (2) History of recent ( 2 mmol/L (11) BMS-Stent < 4 weeks (12) DES-Stent < 6 month (13) Guidance depended Plavix therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N, in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery;Secondary Objective: to demonstrate non-inferiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB area under the curve (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).;Primary end point(s): Primary Endpoint: • CK-MB area under the curve within 24 hours (measurements 4,8,12,16,20,24 hours ± 30 min) after release of the aortic cross clamp | — |
Countries
Germany
Outcome results
None listed