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
Primary Purpose
Cardiovascular Disease, Endothelial Dysfunction
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
folic acid, vitamin B12 and B6 and rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Disease focused on measuring endothelial function, flow mediated dilatation, rosuvastatin, folic acid, B vitamins
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
R
V
Arm Description
Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks
Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin
Outcomes
Primary Outcome Measures
Flow mediated dilatation (FMD)
Secondary Outcome Measures
changes in biochemistry parameters
Full Information
NCT ID
NCT00693589
First Posted
June 5, 2008
Last Updated
June 6, 2008
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT00693589
Brief Title
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
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Endothelial Dysfunction
Keywords
endothelial function, flow mediated dilatation, rosuvastatin, folic acid, B vitamins
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
R
Arm Type
Active Comparator
Arm Description
Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks
Arm Title
V
Arm Type
Active Comparator
Arm Description
Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin
Intervention Type
Drug
Intervention Name(s)
folic acid, vitamin B12 and B6 and rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
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
Primary Outcome Measure Information:
Title
Flow mediated dilatation (FMD)
Time Frame
after 6 weeks of randomized treatment and after 6 weeks of combined treatment
Secondary Outcome Measure Information:
Title
changes in biochemistry parameters
Time Frame
after 6 weeks of randomized treatment and after 6 weeks of combined treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerstin Wustmann, MD
Organizational Affiliation
Cardiology, Inselspital, University hospital Bern
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yves Allemann, MD
Organizational Affiliation
Cardiology, Inselspital, University hospital Bern
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs