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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

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study of the Effects of Clopidogrel on Soluble CD40 Ligand, Endothelial Function and Blood Pressure
Study Start Date : January 2005
Primary Completion Date : December 2009
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. blood pressure

Secondary Outcome Measures :
  1. markers of platelet and endothelial function


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112137


Locations
Germany
University of Cologne
Cologne, Germany, D-50931
Netherlands
St Antonius Hospital Nieuwegein
Nieuwegein, Netherlands, 3435 CM
Sponsors and Collaborators
University of Cologne

Publications:
Responsible Party: Dirk Taubert, University of Cologne
ClinicalTrials.gov Identifier: NCT01112137     History of Changes
Other Study ID Numbers: NLN5031
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: April 28, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors