Ignite Creation Date:
2024-05-05 @ 10:27 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01112137
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2010-04-26
Brief Title:
Effects of Clopidogrel on Blood Pressure
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
Phase IV Study of the Effects of Clopidogrel on Soluble CD40 Ligand Endothelial Function and Blood Pressure
Status:
COMPLETED
Status Verified Date:
2010-04
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:
Context Soluble CD40 ligand sCD40L released from activated platelets induces inflammatory transformation of the vascular endothelium and is an independent predictor of cardiovascular events Arterial hypertension is associated with platelet activation increased sCD40L levels and endothelial dysfunction suggesting that inhibition of platelet-derived sCD40L release may improve endothelial function and lower blood pressure BP
Objective To determine the effects of clopidogrel on sCD40L endothelial function and BP
Design Randomized controlled investigator-blinded parallel-group 2-phase trial in patients with coronary artery disease and essential arterial hypertension and those without hypertension
Intervention Participants receive a single 600-mg clopidogrel loading dose phase I followed by a daily 75-mg clopidogrel maintenance dose over 28 days phase II
Outcome Measures Primary outcome measure is the change in BP from baseline Secondary outcome measures are changes in biomarkers of platelet and endothelial function and their correlation with BP
Objective To determine the effects of clopidogrel on sCD40L endothelial function and BP
Design Randomized controlled investigator-blinded parallel-group 2-phase trial in patients with coronary artery disease and essential arterial hypertension and those without hypertension
Intervention Participants receive a single 600-mg clopidogrel loading dose phase I followed by a daily 75-mg clopidogrel maintenance dose over 28 days phase II
Outcome Measures Primary outcome measure is the change in BP from baseline Secondary outcome measures are changes in biomarkers of platelet and endothelial function and their correlation with BP
Detailed Description:
None
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