Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

Phase 2TerminatedNCT00670202

Brigham and Women's Hospital2 enrolled

Overview

To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Carotid Stenosis

Interventions

Fasudil HydrochlorideDRUG

Fasudil 40 mg three times a day x 14 days

Placebo Oral TabletDRUG

Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with \>= 70% carotid stenosis (unilateral or bilateral) who are scheduled to undergo elective carotid endarterectomy * Age \>= 18 years * Agreement of the operating surgeon for patient to participate Exclusion Criteria: * Surgery scheduled \< 14 days after randomization * Pregnancy * ALT, GGT \> 3x upper limit of normal (ULN) * Creatinine \> 3.5 mg/dL * Prior intolerance to statins * Reluctance to add or change dosage of statin therapy during study

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.

We were going to compare Rho/ROCK expression and eNOS expression/activity in carotid specimens obtained from patients treated with fasudil and compare those to specimens obtained from patients treated with placebo. We anticipated that Rho/ROCK expression and activity would be decreased in spcimens obtained from fasudil treated patients compared to specimens obtained from patients treated with placebo. We also anticipated that eNOS expression and activity would be increased in specimens obtained from patients treated with fasudil compared to specimens obtained from patients treated with placebo.

Time frame: >= 2 weeks

Data from ClinicalTrials.gov

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