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OpenTrials
Completed

NCT Number: NCT01112137

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.

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Key information

Conditions

Blood Pressure Endothelial Function Platelet Function

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Cologne, Cologne, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with coronary artery disease (CAD) and a clinical presentation of stable angina pectoris or acute coronary syndrome who had undergone percutaneous coronary intervention (PCI) with stent implantation
  • 5-year history of essential arterial hypertension with a systolic BP between 140 and 170 mmHg or no hypertension (systolic BP <140mg Hg and diastolic BP <90 mmHg)
  • treatment with clopidogrel (75 mg per day) for 6 to 12 months after PCI
  • continuous use of aspirin (100 mg per day)
  • no change in drug therapy within 3 months prestudy

Exclusion criteria

  • stent thrombosis or another ischemic cardiovascular event following PCI
  • use of other antiplatelet drugs or anticoagulants within 3 months prestudy
  • surgery within 3 months prestudy
  • arrhythmia
  • valvular heart disease
  • hematologic disorder
  • severe renal disorder
  • severe hepatic disorder
  • chronic inflammatory disorder
  • autoimmune disorder
  • acute or chronic infection
  • active malignancy
  • a body-mass index below 18.5 or above 40 kg/m2
  • nonadherence to therapy
  • nonattendance to control visits

Treatment and study plan

clopidogrel

Drug

Primary outcomes

  1. blood pressure

Secondary outcomes

  1. markers of platelet and endothelial function

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Apr 28, 2010
Registry last updated
Apr 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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