Clinical trial NCT03785509: The Compliance of DAPT and Statins on Clinical Outcomes in Percutaneous Coronary Intervention Patients
Official title: The Effect of Persistence and Compliance of Antiplatelet and Dyslipidemia Agents on Cardiovascular Outcomes in Real World Patients Undergoing Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Aggregation Inhibitors
Hydroxymethylglutaryl-coa Reductase Inhibitors
Compliance, Medication
Adherence, Medication
Persistence, Medication
Percutaneous Coronary Intervention
Keywords: DAPT, Statin, Compliance, Persistence, Adherence, PCI
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 47291
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing PCI using stents in 2011 from all medical providers in Korea is selected using National Health Insurance Services.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence density of MACE
timeFrame: 5 years
Secondary outcomes:
measure: Compliance defined as a proportion of days covered (%)
timeFrame: 6 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gang nam-Gu, Ilwon-Dong
Study officials:
affiliation: Samsung Medical Center
name: Jin-Ho Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: