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

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.

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Key information

Conditions

Platelet Aggregation Inhibitors Adherence, Medication Behavior Compliance, Medication Health Behavior Hydroxymethylglutaryl-CoA Reductase Inhibitors Medication Adherence Patient Acceptance of Health Care Patient Compliance Percutaneous Coronary Intervention Persistence, Medication Treatment Adherence and Compliance

Study type

Observational

Primary location

Samsung Medical Center

Seoul, Gang nam-Gu, Ilwon-Dong, 135-710, South Korea

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

No use of stents
Stent not classified into DES or BMS
Use of DES and BMS together at the same initial day

Treatment and study plan

DAPT, Statin

Drug

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

Other names: DES, BMS

Primary outcomes

Incidence density of MACE

Time frame: 5 years

5 year incidence densities of a major adverse clinical events(MACEs) consisting of all-cause death, revascularization, critically ill status and stroke.

Secondary outcomes

Compliance defined as a proportion of days covered (%)

Time frame: 6 month

PDC (Proportion of days covered)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

The Effect of Persistence and Compliance of Antiplatelet and Dyslipidemia Agents on Cardiovascular Outcomes in Real World Patients Undergoing Percutaneous Coronary Intervention

Acronym: CPPCI

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Dec 24, 2018
Registry last updated: Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed