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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023552-90-AT

Enrollment

Registered

2010-12-28

Start date

2011-05-05

Completion date

Unknown

Last updated

2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aorto-coronary bypass surgery in patients with coronary artery disease MedDRA version: 12.1 Level: LLT Classification code 10011077 Term: Coronary artery bypass MedDRA version: 12.1 Level: HLT Classification code 10011085 Term: Ischaemic coronary artery disorders MedDRA version: 12.1 Level: LLT Classification code 10011090 Term: Coronary artery surgery MedDRA version: 12.1 Level: LLT Classification code 10011098 Term: Coronary bypass MedDRA version: 12.1 Level: LLT Classification code 10049

Interventions

Product Name: BQ-123 Product Code: BQ-123 Pharmaceutical Form: Intravenous infusion INN or Proposed INN: BQ-123 CAS Number: 136553-81-6 Current Sponsor code: 4056507 Other descriptive name: endothelin

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: - To asses the effects of intracoronarily administered BQ-123 during cardioplegia on postoperative bypass graft flow ;Secondary Objective: - To evaluate the impact of BQ-123 administration on major adverse cardiac events (MACE) - To asses surrogate parameters for treatment success (left ventricular function, enzymatic infarct size, NT-proBNP) ;Primary end point(s): Coronary artery bypass graft blood flow assessed by Doppler flow probe measurement 15 minutes after protamine administration.	—

Measure

Time frame

Main Objective: - To asses the effects of intracoronarily administered BQ-123 during cardioplegia on postoperative bypass graft flow ;Secondary Objective: - To evaluate the impact of BQ-123 administration on major adverse cardiac events (MACE) - To asses surrogate parameters for treatment success (left ventricular function, enzymatic infarct size, NT-proBNP) ;Primary end point(s): Coronary artery bypass graft blood flow assessed by Doppler flow probe measurement 15 minutes after protamine administration.

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026