The Compliance of DAPT and Statins on Clinical Outcomes i... | NCT03785509

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

NCT03785509

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Dec 24, 2018Actual

Enrollment

47,291Actual

Phase

Not provided

Conditions

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

Interventions

DAPT, Statin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 6, 2017Actual

Primary Completion Date

Feb 6, 2018Actual

Completion Date

Nov 30, 2018Actual

First Submitted Date

Dec 16, 2018

First Submission Date that Met QC Criteria

Dec 21, 2018

First Posted Date

Dec 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2018

Last Update Posted Date

Dec 24, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jin-Ho Choi, MD, PhD, Professor, Samsung Medical CenterPrincipal Investigator

Lead Sponsor

Samsung Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Keywords

DAPT, Statin, Compliance, Persistence, Adherence, PCI

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47,291Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DAPT, Statin	Drug	Compliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal Stent		DES, BMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence density of MACE	5 year incidence densities of a major adverse clinical events(MACEs) consisting of all-cause death, revascularization, critically ill status and stroke.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Compliance defined as a proportion of days covered (%)	PDC (Proportion of days covered)	6 month

Other Outcomes

Not provided

Eligibility Module

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:

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

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients undergoing PCI using stents in 2011 from all medical providers in Korea is selected using National Health Insurance Services.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin-Ho Choi, MD, PhD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul	Gang nam-Gu, Ilwon-Dong	135-710	South Korea

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D055118	Medication Adherence
D010349	Patient Compliance

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

ID	Term
C028145	2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Ancestor Terms

ID	Term
D000924	Anticholesteremic Agents
D000960	Hypolipidemic Agents
D000963	Antimetabolites
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D004791	Enzyme Inhibitors
D057847	Lipid Regulating Agents
D045506	Therapeutic Uses