Blood Pressure Clinical Trial
Official title:
Phase IV Study of the Effects of Clopidogrel on Soluble CD40 Ligand, Endothelial Function and 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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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