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Effects of Clopidogrel on Blood Pressure

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ClinicalTrials.gov Identifier: NCT01112137
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : April 28, 2010
Sponsor:
Information provided by:
University of Cologne

Tracking Information
First Submitted Date  ICMJE April 26, 2010
First Posted Date  ICMJE April 28, 2010
Last Update Posted Date April 28, 2010
Study Start Date  ICMJE January 2005
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2010)
blood pressure
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2010)
markers of platelet and endothelial function
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Clopidogrel on Blood Pressure
Official Title  ICMJE Phase IV Study of the Effects of Clopidogrel on Soluble CD40 Ligand, Endothelial Function and Blood Pressure
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Blood Pressure
  • Endothelial Function
  • Platelet Function
Intervention  ICMJE Drug: Clopidogrel
Study Arms  ICMJE
  • Experimental: Hypertensive individuals: clopidogrel (600 mg, bolus)
    Intervention: Drug: Clopidogrel
  • Experimental: Hypertensive individuals: clopidogrel (75 mg daily)
    Intervention: Drug: Clopidogrel
  • Active Comparator: Normotensive individuals: clopidogrel (600 mg, bolus)
    Intervention: Drug: Clopidogrel
  • Active Comparator: Normotensive individuals: clopidogrel (75 mg, daily)
    Intervention: Drug: Clopidogrel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2010)
46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01112137
Other Study ID Numbers  ICMJE NLN5031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dirk Taubert, University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Cologne
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP