Effect of Plavix on NO (Nitrogen Monoxide) Production of the Endothelial Function

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00648453
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 39
• Location: 1
• Duration (Months): 16
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

To determine whether in the laser Doppler flowmetric parameters characteristic of endothelial dysfunction at patients with clinically manifest atherosclerosis any change can be detected at plavix (clopidogrel) treatment. Laser Doppler /LD/ measurement combined with iontophoresis evaluates the effect of acetylcholine /ACh/ /endothelium dependent/ and sodium nitroprusside /NSP/ /endothelium independent/ on the microcirculation of the skin

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Drug: Clopidogrel (Plavix)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Plavix Treatment on NO Production Measured by Laser Doppler Method Referring to Endothelial Function in Patients With Severe Coronary Heart Disease
• Study Start Date: Dec 1, 2002
• Actual Study Completion Date: Apr 1, 2004

Outcome Measures

Primary Outcome Measures

1. Change of the laser Doppler parameters measured after three months clopidogrel /75 mg/day/ treatment compared to the pre-treatment values. [3 months]

Secondary Outcome Measures

1. Safety of clopidogrel /75 mg/day/ treatment [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Proven, peripheral arterial disease, Fontain II-III stage, patient submitted to secondary prophylactic thrombocyte aggregation inhibiting treatment

• Doppler index < 0,8

Exclusion Criteria:

• Hypersensitivity to the active ingredient or one of the components of the drug

• Active pathological bleeding, e.g. gastric ulcer, intracranial bleeding

• Pregnancy, breast-feeding

• Severe, known hepatic insufficiency

• Severe, known renal insufficiency

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Budapest		Hungary

Sponsors and Collaborators

• Sanofi
• Bristol-Myers Squibb

Investigators

• Study Director: Laszlo Eros, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00648453
• Other Study ID Numbers: L_8564
• First Posted: Apr 1, 2008
• Last Update Posted: Apr 3, 2008
• Last Verified: Apr 1, 2008

• Keywords provided by , ,: Fontain II-III stage
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Clopidogrel

Study Results

No Results Posted as of Apr 3, 2008