High-dose Therapy of Statins (blood lipid reducing drugs) prior to HeartSurgery (Coronary Bypass Grafting)

Phase 1

• Conditions: Patients on a long term statin therapy with established coronary artery disease (CAD) scheduled for isolated surgical myocardial revascularisation (i.e. CABG); Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001795-19-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-27
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2630

Inclusion Criteria

•Patients on long term statin treatment (=30 days) scheduled for isolated CABG, including on- or off-pump or repeat (redo’s) revascularisation procedures
•Stable angina, including non ST-segment-elevation acute coronary syndrome (NSTE-ACS)
•Age = 18 years
•Written informed consent

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 1315
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1315

Exclusion Criteria

•Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or carotid surgery)
Acute ST-segment-elevation myocardial infarction (STEMI)
Or NSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 24 hours from hospital admission
•History of atrial fibrillation or muscle disease (myopathy)
•Current renal (creatinine >2 mg/dL (180 µmol/L), dialysis, kidney transplant)) or hepatic dysfunction (AST or ALT >3x ULN, liver transplant or neoplasm)
•Inability of oral drug intake

Study & Design

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