Blood Pressure Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | April 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University of Cologne | Cologne | |
Netherlands | St Antonius Hospital Nieuwegein | Nieuwegein |
Lead Sponsor | Collaborator |
---|---|
University of Cologne |
Germany, Netherlands,
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. doi: 10.1182/blood-2008-03-143479. Epub 2008 Jul 24. — View Citation
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. — View Citation
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. — View Citation
Henn V, Slupsky JR, Gräfe M, Anagnostopoulos I, Förster R, Müller-Berghaus G, Kroczek RA. CD40 ligand on activated platelets triggers an inflammatory reaction of endothelial cells. Nature. 1998 Feb 5;391(6667):591-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | blood pressure | No | ||
Secondary | markers of platelet and endothelial function | No |
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