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

NCT00693589 | Completed Phase 2

• 1 other identifier: KEK-Nr. 115/03
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Disease; Endothelial Dysfunction

Keywords

endothelial function; flow mediated dilatation; rosuvastatin; folic acid; B vitamins

Outcome Measures

Primary Outcomes (1)

• Flow mediated dilatation (FMD)

  after 6 weeks of randomized treatment and after 6 weeks of combined treatment

Secondary Outcomes (1)

• changes in biochemistry parameters

  after 6 weeks of randomized treatment and after 6 weeks of combined treatment

Study Arms (2)

R

ACTIVE COMPARATOR

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

Drug: folic acid, vitamin B12 and B6 and rosuvastatin

V

ACTIVE COMPARATOR

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

Drug: folic acid, vitamin B12 and B6 and rosuvastatin

Interventions

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

Also known as: Crestor

R; V

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Folic Acid; Vitamin B 12; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Kerstin Wustmann, MD

  Cardiology, Inselspital, University hospital Bern

  STUDY DIRECTOR

• Yves Allemann, MD

  Cardiology, Inselspital, University hospital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: January 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: April 1, 2007
• Last Updated: November 7, 2024

Record last verified: 2008-06