Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

Carotid Stenosis Clinical Trial

Official title:

The Effect of Fasudil on Rho Kinase Activity in Patients Scheduled for Elective Carotid Endarterectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00670202
• Other study ID #: P-002369
• Status: Recruiting
• Phase: Phase 2
• First received: April 29, 2008
• Last updated: May 3, 2010
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: May 2010
• Source: Brigham and Women's Hospital
• Contact: Anju Nohria, MD
• Phone: 617 525-6852
• Email: anohria[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Drug:
• fasudil
40 mg orally three times daily

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Doris Duke Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Rho/ROCK expression with concordant increase in eNOS expression/activity in carotid specimens.		4 weeks	No