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

NCT03785509 | Completed

• 1 other identifier: SMC 2017-04-014-001
• Study Type: observational
• Target: 47,291
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

DAPT, Statin, Compliance, Persistence, Adherence, PCI

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Compliance defined as a proportion of days covered (%)

  6 month

Interventions

DAPT, Statin DRUG

Compliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal Stent

Also known as: DES, BMS

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. All claim of percutaneous coronary intervention using stent in the National Healthcare Insurance Service of Korea between January 1st 2011 and December 31st, 2011

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gang nam-Gu, Ilwon-Dong, 135-710, South Korea

Location

MeSH Terms

Conditions

Medication Adherence; Patient Compliance

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Jin-Ho Choi, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 24, 2018
• Study Start: April 6, 2017
• Primary Completion: February 6, 2018
• Study Completion: November 30, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

KR (1)