Skip to main content
OpenTrials
Completed

NCT Number: NCT00693589

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Endothelial Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

folic acid, vitamin B12 and B6 and rosuvastatin

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

Other names: Crestor

Primary outcomes

  1. Flow mediated dilatation (FMD)

    Time frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment

Secondary outcomes

  1. changes in biochemistry parameters

    Time frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 9, 2008
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.