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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03785509

Collaborator

(none)

47,291

Enrollment

Location

19.8

Actual Duration (Months)

2387.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Platelet Aggregation Inhibitors Hydroxymethylglutaryl-coa Reductase Inhibitors Compliance, Medication Adherence, Medication Persistence, Medication Percutaneous Coronary Intervention	Drug: DAPT, Statin

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 Design

Study Type:

Observational

Actual Enrollment :

47291 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 6, 2017

Actual Primary Completion Date :

Feb 6, 2018

Actual Study Completion Date :

Nov 30, 2018

Outcome Measures

Primary Outcome Measures

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

Compliance defined as a proportion of days covered (%) [6 month]
PDC (Proportion of days covered)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul	Gang nam-Gu, Ilwon-Dong	Korea, Republic of	135-710

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator: Jin-Ho Choi, MD, PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin-Ho Choi, MD, PhD, Professor, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT03785509

Other Study ID Numbers:

SMC 2017-04-014-001

First Posted:

Dec 24, 2018

Last Update Posted:

Dec 24, 2018

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jin-Ho Choi, MD, PhD, Professor, Samsung Medical Center

DAPT, Statin, Compliance, Persistence, Adherence, PCI

Study Results

No Results Posted as of Dec 24, 2018