Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

Mass General Brigham

Status and phase: Terminated; Phase 2

Conditions: Carotid Stenosis

Treatments: Drug: Fasudil Hydrochloride; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT00670202

P-002369

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

2 participants in 2 patient groups, including a placebo group

Drug: Fasudil hydrochloride

Experimental group

Description:

Fasudil hydrochloride 40 mg three times a day X 14 days

Treatment:

Drug: Fasudil Hydrochloride

Drug: Placebo oral tablet

Placebo Comparator group

Description:

Placebo 1 tablet three times daily x 14 days

Treatment:

Drug: Placebo Oral Tablet