The Compliance of DAPT and Statins on Clinical Outcomes in Percutaneous Coronary Intervention Patients (CPPCI)
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|ClinicalTrials.gov Identifier: NCT03785509|
Recruitment Status : Completed
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
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|
|Platelet Aggregation Inhibitors Hydroxymethylglutaryl-coa Reductase Inhibitors Compliance, Medication Adherence, Medication Persistence, Medication Percutaneous Coronary Intervention||Drug: DAPT, Statin|
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|
|Actual Enrollment :||47291 participants|
|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 :||April 6, 2017|
|Actual Primary Completion Date :||February 6, 2018|
|Actual Study Completion Date :||November 30, 2018|
- Drug: DAPT, Statin
Compliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal StentOther Name: DES, BMS
- 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.
- Compliance defined as a proportion of days covered (%) [ Time Frame: 6 month ]PDC (Proportion of days covered)
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785509
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of, 135-710|
|Principal Investigator:||Jin-Ho Choi, MD, PhD||Samsung Medical Center|