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

Phase 2

Completed

• Conditions: Cardiovascular Disease; Endothelial Dysfunction
• Interventions: Drug: folic acid, vitamin B12 and B6 and rosuvastatin

• Registration Number: NCT00693589
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2007-02
• Study Completion: 2007-04
• Status Verified: 2008-06
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-09
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R	folic acid, vitamin B12 and B6 and rosuvastatin	Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks
V	folic acid, vitamin B12 and B6 and rosuvastatin	Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin

Primary Outcome Measures

Name	Time	Method
Flow mediated dilatation (FMD)	after 6 weeks of randomized treatment and after 6 weeks of combined treatment

Secondary Outcome Measures

Name	Time	Method
changes in biochemistry parameters	after 6 weeks of randomized treatment and after 6 weeks of combined treatment