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Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis

NCT02545231 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2020-11-10

No results posted yet for this study

Summary

To compare low dose (1mg) pitavastatin and high dose (4mg) pitavastatin on neointimal hyperplasia and atherosclerosis progression by using optical coherence tomography (OCT) and near-infrared spectroscopy (NIRS) at 12 months follow-up and on clinical adverse cardiovascular events during 3-year follow-up.

Conditions

Interventions

DRUG

Pitavastatin 1mg

To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia

DRUG

Pitavastatin 4mg

To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia

DRUG

Placebo

To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia

Sponsors & Collaborators

  • Korea University Anam Hospital

    lead OTHER

Principal Investigators

  • Do-Sun Lim, MD, PhD · Korea University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2018-12-31
Completion
2020-08-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02545231 on ClinicalTrials.gov