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

Insel Gruppe AG, University Hospital Bern

Status and phase: Completed; Phase 2

Conditions: Endothelial Dysfunction; Cardiovascular Disease

Treatments: Drug: folic acid, vitamin B12 and B6 and rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00693589

KEK-Nr. 115/03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups

R

Active Comparator group

Description:

Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks

Treatment:

Drug: folic acid, vitamin B12 and B6 and rosuvastatin

V

Active Comparator group

Description:

Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin

Treatment:

Drug: folic acid, vitamin B12 and B6 and rosuvastatin