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Effects of Clopidogrel on Blood Pressure

NCT ID: NCT01112137

Last Updated: 2010-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Blood Pressure Endothelial Function Platelet Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hypertensive individuals: clopidogrel (600 mg, bolus)

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

Hypertensive individuals: clopidogrel (75 mg daily)

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

Normotensive individuals: clopidogrel (600 mg, bolus)

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Normotensive individuals: clopidogrel (75 mg, daily)

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Interventions

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Clopidogrel

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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University of Cologne

Locations

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University of Cologne

Cologne, , Germany

Site Status

St Antonius Hospital Nieuwegein

Nieuwegein, , Netherlands

Site Status

Countries

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Germany Netherlands

References

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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. doi: 10.1056/NEJMoa022600.

Reference Type BACKGROUND
PMID: 12646667 (View on PubMed)

Heitzer T, Rudolph V, Schwedhelm E, Karstens M, Sydow K, Ortak M, Tschentscher P, Meinertz T, Boger 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. doi: 10.1161/01.ATV.0000225288.74170.dc. Epub 2006 May 4.

Reference Type BACKGROUND
PMID: 16675725 (View on PubMed)

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. doi: 10.1038/35393.

Reference Type BACKGROUND
PMID: 9468137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18658029 (View on PubMed)

Other Identifiers

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NLN5031

Identifier Type: -

Identifier Source: org_study_id