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NCT03785509 Clinical Trial

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

Percutaneous Coronary Intervention Clinical Trial

— CPPCI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03785509
Other study ID # SMC 2017-04-014-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 6, 2017
Est. completion date November 30, 2018

Study information
Verified date December 2018
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 47291
Est. completion date November 30, 2018
Est. primary completion date February 6, 2018
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DAPT, Statin
Compliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal Stent

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul Gang nam-Gu, Ilwon-Dong

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Compliance defined as a proportion of days covered (%) PDC (Proportion of days covered) 6 month
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