NCT02859480

Brief Summary

This study is a prospective, randomized, open-label, single-center trial designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after percutaneous coronary intervention with the newer drug-eluting stent.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Sep 2015

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

3.8 years

First QC Date

August 4, 2016

Last Update Submit

August 4, 2016

Conditions

Coronary Artery DiseaseCoronary DiseaseCardiovascular Diseases

Keywords

Rosuvastatin CalciumPercutaneous Coronary InterventionDrug-Eluting StentsPatient Outcome AssessmentBiomarkersHyperlipidemiasDyslipidemiasAtherosclerosisHydroxymethylglutaryl-CoA Reductase InhibitorsAnticholesteremic AgentsHypolipidemic AgentsLipid Regulating Agents

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular outcome

    The cumulative incidences of the composite events of cardiac death, myocardial infarction, and repeat revascularization

    Baseline to Final visit (30 months)

Secondary Outcomes (9)

  • All-cause death

    Baseline to Final visit (30 months)

  • Cardiac death

    Baseline to Final visit (30 months)

  • Non-fatal myocardial infarction

    Baseline to Final visit (30 months)

  • Repeat revascularization

    Baseline to Final visit (30 months)

  • Stent thrombosis

    Baseline to Final visit (30 months)

  • +4 more secondary outcomes

Study Arms (2)

Rosuvastatin 5mg

EXPERIMENTAL

Patients are treated with Rosuvastatin 5mg/day for 30 months after percutaneous coronary intervention

Drug: Rosuvastatin 5mg

Rosuvastatin 20mg

ACTIVE COMPARATOR

Patients are treated with Rosuvastatin 20mg/day for 30 months after percutaneous coronary intervention

Drug: Rosuvastatin 20mg

Interventions

Rosuvastatin 5mgDRUG

Rosuvastatin 5mg tablet, q.d., for 30 months

Also known as: Low dose group
Rosuvastatin 5mg
Rosuvastatin 20mgDRUG

Rosuvastatin 5mg tablet, q.d., for 30 months

Also known as: Hihg dose group
Rosuvastatin 20mg

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients underwent percutaneous coronary intervention with drug-eluting stent;

You may not qualify if:

  • Taking other drugs which can influence the lipid profile (eg. Niacin, Fibrates;
  • Serum creatinine level \> 2.0 mg/dL
  • Serum aspartate transaminase \> 3 times upper limit of normal
  • Serum alanine transaminase \> 3 times upper limit of normal
  • Having anaphylactic reaction for Rosuvastatin;
  • Having the other contraindications for Rosuvastatin;
  • Having plan to be pregnant;
  • Having life expectancy less than 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary DiseaseCardiovascular DiseasesHyperlipidemiasDyslipidemiasAtherosclerosis

Interventions

Rosuvastatin CalciumPopulation Groups

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDemographyPopulation Characteristics

Study Officials

  • Hyung Joon Joo, MD, PhD

    Department of Cardiology, Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

  • Do-sun Lim, MD, PhD

    Department of Cardiology, Korea University Anam Hospital

    STUDY CHAIR

Central Study Contacts

Hyung Joon Joo, MD, PhD

CONTACT

+8229205445drjoohj@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, assistant

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 9, 2016

Study Start

September 1, 2015

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

August 9, 2016

Record last verified: 2016-08

Locations

KR(1)