Ignite Creation Date:
2024-05-05 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00693589
Status:
COMPLETED
Last Update Posted:
2008-06-09
First Post:
2008-06-05
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
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10mgd or vitamin supplementation with folic acid 1mg vitamin B12 04mg and B6 10mgd for 6 weeks in a double-blinded design After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None