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Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

This study has been terminated.
(Slow enrollment)
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Anju Nohria, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00670202
First received: April 29, 2008
Last updated: February 10, 2017
Last verified: February 2017
  Purpose
To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.

Condition Intervention Phase
Carotid Stenosis
Drug: Fasudil Hydrochloride
Drug: Placebo Oral Tablet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, placebo controlled, parallel arm design
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Other
Official Title: The Effect of Fasudil on Rho Kinase Activity in Patients Scheduled for Elective Carotid Endarterectomy

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 2
Actual Study Start Date: March 13, 2008
Study Completion Date: January 20, 2011
Primary Completion Date: January 20, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: Fasudil hydrochloride
Fasudil hydrochloride 40 mg three times a day X 14 days
Drug: Fasudil Hydrochloride
Fasudil 40 mg three times a day x 14 days
Other Name: Fasudil
Placebo Comparator: Drug: Placebo oral tablet
Placebo 1 tablet three times daily x 14 days
Drug: Placebo Oral Tablet
Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670202

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Doris Duke Charitable Foundation
Investigators
Principal Investigator: Anju Nohria, MD Brigham and Women's Hospital
  More Information

Responsible Party: Anju Nohria, Associate Physician in Internal Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00670202     History of Changes
Other Study ID Numbers: P-002369
Study First Received: April 29, 2008
Results First Received: February 10, 2017
Last Updated: February 10, 2017

Keywords provided by Brigham and Women's Hospital:
Patients scheduled for elective carotid endarterectomy

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Fasudil
1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2017