Platelet Aggregation InhibitorsCPPCINCT03785509
The Compliance of DAPT and Statins on Clinical Outcomes in Percutaneous Coronary Intervention Patients
An observational study of Platelet Aggregation Inhibitors and Hydroxymethylglutaryl-coa Reductase Inhibitors, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Platelet Aggregation Inhibitors, Hydroxymethylglutaryl-coa Reductase Inhibitors, Compliance, Medication
- What is being tested?
- DAPT, Statin
- How many people
- 47,291 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Apr 2017to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: All patients undergoing PCI using stents in 2011 from all medical providers in Korea is selected using National Health Insurance Services.
Who may be able to join
- 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
Who cannot join
- No use of stents
- Stent not classified into DES or BMS
- Use of DES and BMS together at the same initial day
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul, Gang nam-Gu, Ilwon-Dong, 135-710
About this study
Official title: 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.
Read the 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.
- Conditions
- Platelet Aggregation Inhibitors, Hydroxymethylglutaryl-coa Reductase Inhibitors, Compliance, Medication, Adherence, Medication, Persistence, Medication, Percutaneous Coronary Intervention
- Being tested
- DAPT, Statin
- Keywords
- DAPT, Statin, Compliance, Persistence, Adherence, PCI
- Medical subject headings
- Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAPT, StatinDrug
Also called DES, BMS
Compliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal Stent
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
Compliance defined as a proportion of days covered (%)
PDC (Proportion of days covered)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start6 Apr 2017
- Primary completion6 Feb 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Aggregation InhibitorsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 47,291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Ho Choi, Samsung Medical Center
- Investigators
- Jin-Ho Choi, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785509
- Sponsor's protocol ID
- SMC 2017-04-014-001
- Acronym
- CPPCI
- Status last verified
- Dec 2018
- First submitted
- 16 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Persistence and Compliance of Antiplatelet and Dyslipidemia Agents on Cardiovascular Outcomes in Real World Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03785509
- Acronym / sponsor ID
- CPPCI / SMC 2017-04-014-001
- Conditions
- Platelet Aggregation Inhibitors, Hydroxymethylglutaryl-coa Reductase Inhibitors, Compliance, Medication, Adherence, Medication, Persistence, Medication, Percutaneous Coronary Intervention
- Keywords
- DAPT, Statin, Compliance, Persistence, Adherence, PCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47,291 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing PCI using stents in 2011 from all medical providers in Korea is selected using National Health Insurance Services.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- No use of stents
- Stent not classified into DES or BMS
- Use of DES and BMS together at the same initial day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAPT, StatinAlso: DES, BMSCompliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal Stent | Drug | – |
Primary outcome
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.
1 secondary outcome
Compliance defined as a proportion of days covered (%)
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
Related trials for Platelet Aggregation Inhibitors
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
Active, not recruitingPhase 4
Effect of Two Weeks of Low-Dose Apixaban on Platelet Reactivity in Patients With Stable Coronary Artery Disease on Dual Antiplatelet Therapy (Aspirin and Clopidogrel)
Coronary Artery Disease, High On-treatment Platelet Reactivity (HTPR)
Not yet recruitingObservational study
Regulation of Platelet Function in Older Patients With Atrial Fibrillation
Atrial Fibrillation, Thrombotic Risk
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Ho Choi, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Aggregation Inhibitors and Hydroxymethylglutaryl-coa Reductase Inhibitors, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence density of MACE (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.