Official Title: “Effect of Homocysteine-Lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-Dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease”

Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Study Primary Completion Date: February 2007

Study design: 36 pts with CAD or PAD are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin B12 0.4mg and B6 10mg/d for 6 weeks in a double-blinded design. After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.

Intervention(s) in this Clinical Trial

• Drug: folic acid, vitamin B12 and B6 and rosuvastatin
  • Vitamin supplementation with folic acid 1mg/d, vitamin B12 0.4mg/d and B6 10mg/d po for 6 weeks alone vs. rosuvastatin 10mg/d for 6 weeks alone and thereafter combined treatment for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: R
  • Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks
• Active Comparator: V
  • Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin

Primary Measures

• Flow mediated dilatation (FMD)
  • Time Frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment
    Safety Issue?: No

Secondary Measures

• changes in biochemistry parameters
  • Time Frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment
    Safety Issue?: No

Inclusion Criteria:

• CAD or PAD (>50% luminal stenosis), previous myocardial infarction or bypass surgery
• >3 month ago
• history of percutaneous coronary intervention (PTCA or stenting)
• confirmed consent

Exclusion Criteria:

• myocardial infarction or acute coronary syndrome or bypass surgery <3 month ago
• ongoing treatment with statins
• ongoing vitamin supplementation with folic acid and B vitamins
• <18 years
• active smokers
• uncontrolled arterial hypertension
• renal insufficiency
• atrial fibrillation
• liver disease
• NYHA class >2
• familial hypercholesterolemia

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital Inselspital, Berne

Overall Clinical Trial Officials and Contacts

Kerstin Wustmann, MD Study Director Cardiology, Inselspital, University hospital Bern  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00693589

Study ID Number: KEK-Nr. 115/03

ClinicalTrials.gov Identifier: NCT00693589

Health Authority: Switzerland: Swissmedic