Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

• ClinicalTrials.gov Identifier: NCT00670202
• Recruitment Status: Terminated
• First Posted: May 1, 2008
• Results First Posted: March 29, 2017
• Last Update Posted: March 29, 2017
• Sponsor: Brigham and Women's Hospital
• Collaborator: Doris Duke Charitable Foundation
• Information provided by (Responsible Party): Anju Nohria, Brigham and Women's Hospital

Tracking Information

• First Submitted Date: April 29, 2008
• First Posted Date: May 1, 2008
• Results First Submitted Date: February 10, 2017
• Results First Posted Date: March 29, 2017
• Last Update Posted Date: March 29, 2017
• Actual Study Start Date: March 13, 2008
• Actual Primary Completion Date: January 20, 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 10, 2017)

Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens. [ Time Frame: >= 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.

• Original Primary Outcome Measures (submitted: April 30, 2008): Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens. [ Time Frame: 4 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis
• Official Title: The Effect of Fasudil on Rho Kinase Activity in Patients Scheduled for Elective Carotid Endarterectomy
• Brief Summary: To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized, placebo controlled, parallel arm design

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other

• Condition: Carotid Stenosis

Intervention

• Drug: Fasudil Hydrochloride
  Fasudil 40 mg three times a day x 14 days
  Other Name: Fasudil
• Drug: Placebo Oral Tablet
  Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days
  Other Name: Placebo

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 10, 2017): 2
• Original Estimated Enrollment (submitted: April 30, 2008): 60
• Actual Study Completion Date: January 20, 2011
• Actual Primary Completion Date: January 20, 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00670202
• Other Study ID Numbers: P-002369
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Anju Nohria, Brigham and Women's Hospital
• Study Sponsor: Brigham and Women's Hospital
• Collaborators: Doris Duke Charitable Foundation

Investigators

• Principal Investigator: Anju Nohria, MD; Brigham and Women's Hospital

• PRS Account: Brigham and Women's Hospital
• Verification Date: February 2017