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

December 21, 2018 updated by: Jin-Ho Choi, Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

47291

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gang nam-Gu, Ilwon-Dong
      • Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of, 135-710
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2017

Primary Completion (Actual)

February 6, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

December 16, 2018

First Submitted That Met QC Criteria

December 21, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Actual)

December 24, 2018

Last Update Submitted That Met QC Criteria

December 21, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SMC 2017-04-014-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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