Effects of Clopidogrel on Blood Pressure

April 27, 2010 updated by: University of Cologne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, D-50931
        • University of Cologne
  • Netherlands
      • Nieuwegein, Netherlands, 3435 CM
        • St Antonius Hospital Nieuwegein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
blood pressure

Secondary Outcome Measures

Outcome Measure
markers of platelet and endothelial function

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 27, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NLN5031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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