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

Completed

• Conditions: Platelet Aggregation Inhibitors; Percutaneous Coronary Intervention; Hydroxymethylglutaryl-coa Reductase Inhibitors; Compliance, Medication; Adherence, Medication; Persistence, Medication

• Registration Number: NCT03785509
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-04-06
• Primary Completion: 2018-02-06
• Study Completion: 2018-11-30
• Status Verified: 2018-12
• Study First Submitted: 2018-12-16
• Study First Submitted QC: 2018-12-21
• Last Update Submitted: 2018-12-21
• Study First Posted: 2018-12-24
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 47291

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence density of MACE	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 Outcome Measures

Name	Time	Method
Compliance defined as a proportion of days covered (%)	6 month	PDC (Proportion of days covered)

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of