Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

Phase 2

Terminated

• Conditions: Carotid Stenosis
• Interventions: Drug: Fasudil Hydrochloride; Drug: Placebo Oral Tablet

• Registration Number: NCT00670202
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-13
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-04-30
• Study First Posted: 2008-05-01
• Primary Completion: 2011-01-20
• Study Completion: 2011-01-20
• Status Verified: 2017-02
• Results First Submitted: 2017-02-10
• Results First Submitted QC: 2017-02-10
• Last Update Submitted: 2017-02-10
• Results First Posted: 2017-03-29
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: Fasudil hydrochloride	Fasudil Hydrochloride	Fasudil hydrochloride 40 mg three times a day X 14 days
Drug: Placebo oral tablet	Placebo Oral Tablet	Placebo 1 tablet three times daily x 14 days

Primary Outcome Measures

Name	Time	Method
Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.	>= 2 weeks	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.

Trial Locations

Locations (1)

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