The Effect of Fasudil on Vascular Function in Humans

Phase 2

Completed

• Conditions: Atherosclerosis; Hypercholesterolemia

• Registration Number: NCT00120718
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

The purpose of the study is to evaluate how the rho kinase inhibitor, fasudil, affects vascular function in patients with atherosclerosis and hyperlipidemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2005-07-12
• Study First Submitted QC: 2005-07-18
• Study First Posted: 2005-07-19
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-26
• Last Update Posted: 2008-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Coronary artery disease
• Hyperlipidemia -OR-
• Healthy adults

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Exclusion Criteria

• Unstable angina, myocardial infarction or revascularization within 3 months
• Symptomatic heart failure
• Creatinine > 3.0 mg/dl
• Liver enzymes > 3X upper limit of normal
• Chronic hypoxia
• Significant anemia
• Chronic inflammatory disease
• Pregnancy
• Willing to withdraw statins for duration of study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Vascular reactivity

Secondary Outcome Measures

Name	Time	Method
Rho kinase expression
Rho kinase activity
eNOS expression
eNOS activity
inflammatory markers

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States