Effects of Clopidogrel on Blood Pressure

This study has been completed.

Sponsor:

Information provided by:

University of Cologne

ClinicalTrials.gov Identifier:

NCT01112137

First received: April 26, 2010

Last updated: April 27, 2010

Last verified: April 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	April 26, 2010
Last Updated Date	April 27, 2010
Start Date ^ICMJE	January 2005
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 27, 2010)	blood pressure [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01112137 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 27, 2010)	markers of platelet and endothelial function [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Blood Pressure Endothelial Function Platelet Function
Intervention ^ICMJE	Drug: Clopidogrel
Study Arm (s)	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 *	Heeschen C, Dimmeler S, Hamm CW, van den Brand MJ, Boersma E, Zeiher AM, Simoons ML; CAPTURE Study Investigators. Soluble CD40 ligand in acute coronary syndromes. N Engl J Med. 2003 Mar 20;348(12):1104-11. Heitzer T, Rudolph V, Schwedhelm E, Karstens M, Sydow K, Ortak M, Tschentscher P, Meinertz T, Böger R, Baldus S. Clopidogrel improves systemic endothelial nitric oxide bioavailability in patients with coronary artery disease: evidence for antioxidant and antiinflammatory effects. Arterioscler Thromb Vasc Biol. 2006 Jul;26(7):1648-52. Epub 2006 May 4. Henn V, Slupsky JR, Grafe M, Anagnostopoulos I, Forster R, Muller-Berghaus G, Kroczek RA. CD40 ligand on activated platelets triggers an inflammatory reaction of endothelial cells. Nature. 1998 Feb 5;391(6667):591-4. Chen C, Chai H, Wang X, Jiang J, Jamaluddin MS, Liao D, Zhang Y, Wang H, Bharadwaj U, Zhang S, Li M, Lin P, Yao Q. Soluble CD40 ligand induces endothelial dysfunction in human and porcine coronary artery endothelial cells. Blood. 2008 Oct 15;112(8):3205-16. Epub 2008 Jul 24.
* 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
Enrollment ^ICMJE	46
Completion Date	April 2010
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
Gender	Both
Ages	45 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany, Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01112137
Other Study ID Numbers ^ICMJE	NLN5031
Has Data Monitoring Committee	No
Responsible Party	Dirk Taubert, University of Cologne
Study Sponsor ^ICMJE	University of Cologne
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	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

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