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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
Sponsor:
Information provided by (Responsible Party):
Jin-Ho Choi, Samsung Medical Center

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
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.


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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 : April 6, 2017
Actual Primary Completion Date : February 6, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: DAPT, Statin
    Compliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal Stent
    Other Name: DES, BMS


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Compliance defined as a proportion of days covered (%) [ Time Frame: 6 month ]
    PDC (Proportion of days covered)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785509


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jin-Ho Choi, MD, PhD Samsung Medical Center

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Responsible Party: Jin-Ho Choi, MD, PhD, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03785509     History of Changes
Other Study ID Numbers: SMC 2017-04-014-001
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jin-Ho Choi, Samsung Medical Center:
DAPT, Statin, Compliance, Persistence, Adherence, PCI

Additional relevant MeSH terms:
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Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents