Clinical trial NCT04734028: PTRG-DES Consortium
Official title: Platelet Function and genoType-Related Long-term progGosis in DES-treated Patients : A Consortium From Multi-centered Registries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Clopidogrel, Poor Metabolism of
Platelet Dysfunction
Stent Thrombosis
Keywords: Asian population
VerifyNow assay
Genotype
Inflammation
Lead sponsor: Gyeongsang National University Hospital
Sponsor class: OTHER
Collaborators: name: Korean Society of Interventional Cardiology
First posted: 2021-02-02
Enrollment: 13160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Significant CAD patients treated with uneventful DES implantation

Brief summary: The PTRG-DES consortium is a coalition composed of multi-center, real-world registries including CAD patients treated with DES in South Korea. From 9 academic registries in Korea, a total of 13,160 patients were enrolled for this database between July 2003 and August 2018. The aim of the study was to investigate long-term prognostic implications of platelet function and genotypes after DES implantation for significant CAD in South Korea.

Detailed description: The investigators enrolled patients treated with DES during DAPT including clopidogrel who had at least one of VerifyNow test (PRU and ARU) and genotyping. In this consortium, the investigators tried to find the unique characteristics of East Asians based on platelet function, genotype and inflammatory markers.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients at every centre successfully treated with one or more DES approved by the US FDA or CE mark and who were adequately loaded with clopidogrel were eligible for enrolment, regardless of patient or lesion complexity.

Exclusion Criteria:

* the occurrence of a major complication during the procedure or before platelet function testing, or if bypass surgery was planned after PCI.
* Any P2Y12 inhibitor other than clopidogrel
* PCI strategy other than DES
* Needed oral anticoagulant (e.g. atrial fibrillation)

Primary outcomes:
measure: MACCE
timeFrame: upto 10 years
Secondary outcomes:
measure: Major bleeding
timeFrame: upto 10 years
measure: MACE1
timeFrame: upto 10 years
measure: MACE2
timeFrame: upto 10 years
measure: Each clinical event
timeFrame: upto 10 years
Other outcomes:
measure: Clinical event according to gender
timeFrame: upto 10 years
measure: Clinical event according to age
timeFrame: upto 10 years
measure: Clinical event according to BMI
timeFrame: upto 10 years
measure: Clinical event according to anemia
timeFrame: upto 10 years
measure: Clinical event according to DM
timeFrame: upto 10 years
measure: Clinical event according to CKD
timeFrame: upto 10 years
measure: Clinical event according to disease entity (AMI vs. non-AMI)
timeFrame: upto 10 years
measure: Clinical event according to LV dysfunction (LV EF)
timeFrame: upto 10 years
measure: Clinical event according to complex PCI
timeFrame: upto 10 years
measure: Clinical event according to time point post-PCI
timeFrame: upto 10 years
Locations:
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
state: Gyeongsangnam-do
Study officials:
affiliation: Korea University Anam Hospital, Korea University School of Medicine
name: Do-Sun Lim, MD, PhD
role: STUDY_CHAIR
References:
citation: Kim HK, Tantry US, Smith SC Jr, Jeong MH, Park SJ, Kim MH, Lim DS, Shin ES, Park DW, Huo Y, Chen SL, Bo Z, Goto S, Kimura T, Yasuda S, Chen WJ, Chan M, Aradi D, Geisler T, Gorog DA, Sibbing D, Lip GYH, Angiolillo DJ, Gurbel PA, Jeong YH. The East Asian Paradox: An Updated Position Statement on the Challenges to the Current Antithrombotic Strategy in Patients with Cardiovascular Disease. Thromb Haemost. 2021 Apr;121(4):422-432. doi: 10.1055/s-0040-1718729. Epub 2020 Nov 10.
citation: Her AY, Jeong YH, Kim BK, Joo HJ, Chang K, Park Y, Song YB, Ahn SG, Suh JW, Lee SY, Cho JR, Kim HS, Kim MH, Lim DS, Shin ES; PTRG-DES Consortium Investigators. Platelet Function and Genotype after DES Implantation in East Asian Patients: Rationale and Characteristics of the PTRG-DES Consortium. Yonsei Med J. 2022 May;63(5):413-421. doi: 10.3349/ymj.2022.63.5.413.