Effects of Clopidogrel on Blood Pressure
|ClinicalTrials.gov Identifier: NCT01112137|
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : April 28, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Endothelial Function Platelet Function||Drug: Clopidogrel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Phase IV Study of the Effects of Clopidogrel on Soluble CD40 Ligand, Endothelial Function and Blood Pressure|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||April 2010|
|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|
- blood pressure
- markers of platelet and endothelial function
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112137
|University of Cologne|
|Cologne, Germany, D-50931|
|St Antonius Hospital Nieuwegein|
|Nieuwegein, Netherlands, 3435 CM|