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Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Brigham and Women's Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00670202
First received: April 29, 2008
Last updated: May 3, 2010
Last verified: May 2010
History of Changes
  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
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: The Effect of Fasudil on Rho Kinase Activity in Patients Scheduled for Elective Carotid Endarterectomy

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
fasudil
 Drug: fasudil
40 mg orally three times daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670202

Contacts
Contact: Anju Nohria, MD 617 525-6852 anohria@partners.org
Contact: Jeanne Doyle, BS, RN. BC 617 525-7055 jdoyle7@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Anju Nohria, MD     617-525-6852     anohria@partners.org    
Contact: Jeanne Doyle, BS, RN, BC     617 525-7055     jdoyle7@partners.org    
Principal Investigator: Mark A. Creager, MD            
Sub-Investigator: Anju Nohria, MD            
Sub-Investigator: Christopher Owens, MD            
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

No publications provided

Responsible Party: Mark A. Creager, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00670202     History of Changes
Other Study ID Numbers: P-002369
Study First Received: April 29, 2008
Last Updated: May 3, 2010
Health Authority: United States: Food and Drug Administration

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
 Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013