Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-13

Study Completion Date

2011-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis

NCT01602471

Carotid Stenosis

TERMINATED PHASE2

TRACER RGD-K5 Carotid Plaque Imaging Study

NCT01968226

Carotid Artery Disease Carotid Stenosis

TERMINATED PHASE2

Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb)

NCT01718288

Peripheral Arterial Disease

COMPLETED PHASE4

Carnosine for Peripheral Arterial Disease Patients

NCT05371145

Peripheral Arterial Disease

RECRUITING PHASE1/PHASE2

TRACER [F-18] RDG-K5 Carotid Plaque Imaging Study

NCT03364270

Carotid Arteries

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, placebo controlled, parallel arm design

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Drug: Fasudil hydrochloride

Fasudil hydrochloride 40 mg three times a day X 14 days

Group Type EXPERIMENTAL

Fasudil Hydrochloride

Intervention Type DRUG

Fasudil 40 mg three times a day x 14 days

Drug: Placebo oral tablet

Placebo 1 tablet three times daily x 14 days

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fasudil Hydrochloride

Fasudil 40 mg three times a day x 14 days

Intervention Type DRUG

Placebo Oral Tablet

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fasudil Placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No