The Compliance of DAPT and Statins on Clinical Outcomes in Percutaneous Coronary Intervention Patients

NCT ID: NCT03785509

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47291 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-06

Study Completion Date

2018-11-30

Brief Summary

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A nationwide retrospective cohort study. To investigate the real world medication compliance and the relation with clinical outcomes.

The persistence and compliance to dual anti-platelet therapy(DAPT) and dyslipidemia agents are important for the patients undergoing percutaneous coronary intervention. But, the discontinuation and compliance rate are unknown in the real world setting.

Detailed Description

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A nationwide retrospective cohort study. The persistence and compliance to dual anti-platelet therapy(DAPT) and dyslipidemia agents are important for the patients undergoing percutaneous coronary intervention. The discontinuation and uncompliance may increase a risk. But, the discontinuation and compliance rate are not well known in the real world patients undergoing bare metal stents(BMS) and drug eluting stents(DES) insertion.

To investigate the real world medication compliance and the relation with clinical outcomes, administrative claim data was extracted from the Korean National Healthcare Insurance(KNHI) database.

All Korean patient date undergoing PCI from January 1, 2011 to December 2011 is extracted. 5 year clinical outcomes are investigated.

Primary outcomes are the MACE including all-cause death, revascularization, critically ill status, and stroke) classified by the medication compliance. Medication complinace is measured by proportion of days covered(PDC)

Secondary outcomes are the patterns of medication persistence and its outcomes to understand critical points.

Conditions

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Platelet Aggregation Inhibitors Hydroxymethylglutaryl-coa Reductase Inhibitors Compliance, Medication Adherence, Medication Persistence, Medication Percutaneous Coronary Intervention

Keywords

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DAPT, Statin, Compliance, Persistence, Adherence, PCI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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DAPT, Statin

Compliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal Stent

Intervention Type DRUG

Other Intervention Names

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DES, BMS

Eligibility Criteria

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Inclusion Criteria

1\. All claim of percutaneous coronary intervention using stent in the National Healthcare Insurance Service of Korea between January 1st 2011 and December 31st, 2011

Exclusion Criteria

1. No use of stents
2. Stent not classified into DES or BMS
3. Use of DES and BMS together at the same initial day
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin-Ho Choi

MD, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Ho Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, Gang nam-Gu, Ilwon-Dong, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SMC 2017-04-014-001

Identifier Type: -

Identifier Source: org_study_id