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Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

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

Tracking Information
First Submitted Date  ICMJE April 29, 2008
First Posted Date  ICMJE May 1, 2008
Results First Submitted Date  ICMJE February 10, 2017
Results First Posted Date  ICMJE March 29, 2017
Last Update Posted Date March 29, 2017
Actual Study Start Date  ICMJE March 13, 2008
Actual Primary Completion Date January 20, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: April 30, 2008)
Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens. [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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  ICMJE Carotid Stenosis
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 10, 2017)
2
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2008)
60
Actual Study Completion Date  ICMJE January 20, 2011
Actual Primary Completion Date January 20, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00670202
Other Study ID Numbers  ICMJE P-002369
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anju Nohria, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Doris Duke Charitable Foundation
Investigators  ICMJE
Principal Investigator: Anju Nohria, MD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP