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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Disease Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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R

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

Group Type ACTIVE_COMPARATOR

folic acid, vitamin B12 and B6 and rosuvastatin

Intervention Type DRUG

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

V

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

Group Type ACTIVE_COMPARATOR

folic acid, vitamin B12 and B6 and rosuvastatin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No