Trial record 20 of 33 for:    Open Studies | carotid endarterectomy

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
Doris Duke Charitable Foundation
Information provided by:
Brigham and Women's Hospital Identifier:
First received: April 29, 2008
Last updated: May 3, 2010
Last verified: May 2010

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:

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
Drug: fasudil
40 mg orally three times daily


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00670202

Contact: Anju Nohria, MD 617 525-6852
Contact: Jeanne Doyle, BS, RN. BC 617 525-7055

United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Anju Nohria, MD    617-525-6852   
Contact: Jeanne Doyle, BS, RN, BC    617 525-7055   
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
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 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 processed this record on March 26, 2015