Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

NCT00670202 | Terminated Phase 2 Results

• 1 other identifier: P-002369
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carotid Stenosis

Keywords

Patients scheduled for elective carotid endarterectomy

Outcome Measures

Primary Outcomes (1)

• Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.

  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.

  >= 2 weeks

Study Arms (2)

Drug: Fasudil hydrochloride

EXPERIMENTAL

Fasudil hydrochloride 40 mg three times a day X 14 days

Drug: Fasudil Hydrochloride

Drug: Placebo oral tablet

PLACEBO COMPARATOR

Placebo 1 tablet three times daily x 14 days

Drug: Placebo Oral Tablet

Interventions

Fasudil Hydrochloride DRUG

Fasudil 40 mg three times a day x 14 days

Also known as: Fasudil

Drug: Fasudil hydrochloride

Placebo Oral Tablet DRUG

Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days

Also known as: Placebo

Drug: Placebo oral tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

fasudil

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Study was terminated early due to poor enrollment. The patients and physicians remained blinded to study drug assignment for the 2 patients who completed the protocol and no analyses were performed.

Results Point of Contact

• Title: Anju Nohria
• Organization: Brigham and Women's Hospital

anohria@partners.org

617-525-7052

Study Officials

• Anju Nohria, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician in Internal Medicine

Model Details: Randomized, placebo controlled, parallel arm design

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: March 13, 2008
• Primary Completion: January 20, 2011
• Study Completion: January 20, 2011
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Locations

US (1)