Effects of Clopidogrel on Blood Pressure
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase IV Study of the Effects of Clopidogrel on Soluble CD40 Ligand, Endothelial Function and Blood Pressure|
- blood pressure [ Designated as safety issue: No ]
- markers of platelet and endothelial function [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Study Completion Date:||April 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|Experimental: Hypertensive individuals: clopidogrel (600 mg, bolus)||Drug: Clopidogrel|
|Experimental: Hypertensive individuals: clopidogrel (75 mg daily)||Drug: Clopidogrel|
|Active Comparator: Normotensive individuals: clopidogrel (600 mg, bolus)||Drug: Clopidogrel|
|Active Comparator: Normotensive individuals: clopidogrel (75 mg, daily)||Drug: Clopidogrel|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112137
|University of Cologne|
|Cologne, Germany, D-50931|
|St Antonius Hospital Nieuwegein|
|Nieuwegein, Netherlands, 3435 CM|