Short-term endothelin A receptor blockade in patients with on-pump coronary artery bypass grafting - BQ-123 in CABG

Phase 1

• Conditions: aorto-coronary bypass surgery in patients with coronary artery disease; MedDRA version: 12.1Level: LLTClassification code 10011077Term: Coronary artery bypass; MedDRA version: 12.1Level: HLTClassification code 10011085Term: Ischaemic coronary artery disorders; MedDRA version: 12.1Level: LLTClassification code 10011090Term: Coronary artery surgery; MedDRA version: 12.1Level: LLTClassification code 10011098Term: Coronary bypass; MedDRA version: 12.1Level: LLTClassification code 10049887Term: Coronary revascularisation; MedDRA version: 12.1Level: LLTClassification code 10054366Term: Coronary revascularization

• Registration Number: EUCTR2010-023552-90-AT
• Lead Sponsor: Medizinische Universität Wien, Abteilung für Herzchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-28
• Study Completion: 2015-10-15
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Patients undergoing on-pump coronary artery bypass grafting using the left mammary artery to the left anterior descendent artery and at least one vein graft due to coronary artery disease, aged 18 years and above.
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

Exclusion Criteria

•Significant liver disease (Transaminases and gamma-GT > 3 fold upper limit)
•Glomerular filtration rate <40mL/h
•History of severe congestive heart failure (Left ventricular ejection fraction <40%)
•Current atrial fibrillation
•Significant valvular heart disease requiring valve reconstruction or replacement
•Primary myocardial disease
•Acute coronary syndrome or cardiogenic shock (sRR <90mmHg or need for inotropic support)
•Women with child-bearing potential
•Inability to read, understand and sign the informed consent
•Life expectancy <1y
•Prior organ transplantation
•Participation in a clinical trial using an investigational medical product

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified