The Effect of Fasudil on Vascular Function in Humans

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia; Atherosclerosis

Treatments: Drug: fasudil

Study type: Interventional

Funder types: Other

Identifiers

NCT00120718

2002-P-000890

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind