NCT01112137

Effects of Clopidogrel on Blood Pressure

Phase IV Study of the Effects of Clopidogrel on Soluble CD40 Ligand, Endothelial Function and Blood Pressure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Pressure
• Endothelial Function
• Platelet Function

Interventions

Type	Name	Description
DRUG	Clopidogrel
DRUG	Clopidogrel
DRUG	Clopidogrel
DRUG	Clopidogrel

Timeline

• Start date: 2005-01-01
• Primary completion: 2009-12-01
• Completion: 2010-04-01
• First posted: 2010-04-28
• Last updated: 2010-04-28

Locations

2 sites across 2 countries: Germany, Netherlands