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Coronary Artery DiseasePTRGNCT04734028

PTRG-DES Consortium

An observational study of Coronary Artery Disease and Clopidogrel, Poor Metabolism of, run by Gyeongsang National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Clopidogrel Tablets
Type of treatment
Pill or oral medicine
How many people
13,160 participants
Where
1 siteSouth Korea
Study dates
9 Jul 2003to 30 Jun 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Significant CAD patients treated with uneventful DES implantation

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Gyeongsang National University Changwon Hospital

    Changwon, Gyeongsangnam-do, 51472

Other trials in South Korea

About this study

Official title: Platelet Function and genoType-Related Long-term progGosis in DES-treated Patients : A Consortium From Multi-centered Registries

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.

Read the 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.

Being tested
Clopidogrel Tablets
Keywords
Asian population, VerifyNow assay, Genotype, Inflammation
Medical subject headings
Coronary Artery Disease, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clopidogrel TabletsDrug

    Also called aspirin

    DES-treated patients were treated with clopidogrel 75 mg daily and aspirin 100 mg daily

Study groups in NCT04734028
Study groupRoleWhat they receive
PTRG-DES registryAfter DES implantation, CAD patients were treated with DAPT with clopidogrel and aspirin. During hospitalization, their platelet function, genotype and inflammation biomarker were evaluated.
Receives: Drug: Clopidogrel Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACCE

    All-cause death, MI, stroke or stent thrombosis

    Measured: upto 10 years

Secondary outcomes (4)

  1. Major bleeding

    BARC type 3-5 bleeding

    Measured: upto 10 years

  2. MACE1

    CV death, MI and stent thrombosis

    Measured: upto 10 years

  3. MACE2

    CV death, MI, stent thrombosis and revascularization

    Measured: upto 10 years

  4. Each clinical event

    all-cause death, CV death, MI, stroke, stent thrombosis, revascularization or major bleeding

    Measured: upto 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2021
  2. Study start9 Jul 2003
  3. Primary completion7 Aug 2018
  4. Study completion30 Jun 2020

Resources

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
Case-control
Time perspective
Prospective
Enrolment
13,160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04734028
Sponsor's protocol ID
PTRG
Acronym
PTRG
Status last verified
Mar 2022
First submitted
28 Jan 2021
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: If there are the chances of collaboration work, we will share IPD with other groups.

Publications

  • 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.

    PubMed 33171520

  • Kang DO, Kim S, Her AY, Shin ES. Drug-Coated Balloon-Based Strategy for De Novo Coronary Artery Disease Across Complex and High-Risk Indicated Percutaneous Coronary Intervention Risk Categories: A Multicenter Registry Study. Catheter Cardiovasc Interv. 2026 Jul 16. doi: 10.1002/ccd.70756. Online ahead of print.

    PubMed 42461258

  • Kim SJ, Her AY, Joo HJ, Chang K, Kim BK, Song YB, Ahn SG, Suh JW, Lee SY, Cho JR, Kim HS, Jeong YH, Kim MH, Lim DS, Shin ES. Sex Differences in Prognostic Implications of CYP2C19 Genotype After Drug-Eluting Stent Implantation. J Am Heart Assoc. 2026 May 5;15(9):e045981. doi: 10.1161/JAHA.125.045981. Epub 2026 Apr 28.

    PubMed 42047190

  • Kang J, Park S, Park KW, Joo HJ, Chang K, Park Y, Song YB, Ahn SG, Suh JW, Lee SY, Cho JR, Her AY, Jeong YH, Kim BK, Kim MH, Shin ES, Lim DS, Hwang D, Han JK, Yang HM, Koo BK, Kim HS; PTRG Investigators. Long-Term Impact of Platelet Reactivity and Clinical Risk on Clinical Outcomes in Patients With Coronary Artery Disease: Analysis of the PTRG-DES Registry. Circ Cardiovasc Interv. 2025 Oct;18(10):e015737. doi: 10.1161/CIRCINTERVENTIONS.125.015737. Epub 2025 Sep 22.

    PubMed 40977391

  • Ahn H, Chu HW, Her AY, Jeong YH, Kim BK, Joo HJ, Chang K, Park Y, Ahn SG, Lee SY, Cho JR, Kim HS, Kim MH, Lim DS, Shin ES, Suh JW; PTRG-DES Consortium Investigators. Effect of Calcium Channel Blockers on Antiplatelet Activity of Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention: Insights from the PTRG-DES Consortium. J Cardiovasc Pharmacol Ther. 2024 Jan-Dec;29:10742484241298150. doi: 10.1177/10742484241298150.

    PubMed 39552592

  • Kim JH, Lee SJ, Cha JJ, Park JH, Hong SJ, Ahn TH, Kim BK, Chang K, Park Y, Song YB, Ahn SG, Suh JW, Lee SY, Cho JR, Her AY, Jeong YH, Kim HS, Kim MH, Shin ES, Lim DS; PTRG-DES Consortium Investigators. Prognostic Impact of CYP2C19 Genotypes on Long-Term Clinical Outcomes in Older Patients After Percutaneous Coronary Intervention. J Am Heart Assoc. 2024 May 21;13(10):e032248. doi: 10.1161/JAHA.123.032248. Epub 2024 May 18.

    PubMed 38761068

  • Won KB, Kim HJ, Cho JH, Lee SY, Her AY, Kim BK, Joo HJ, Park Y, Chang K, Song YB, Ahn SG, Suh JW, Cho JR, Kim HS, Kim MH, Lim DS, Kim SW, Jeong YH, Shin ES. Different association of atherogenic index of plasma with the risk of high platelet reactivity according to the presentation of acute myocardial infarction. Sci Rep. 2024 May 13;14(1):10894. doi: 10.1038/s41598-024-60999-3.

    PubMed 38740817

  • Jin X, Jeong YH, Lee KM, Yun SC, Kim BK, Joo HJ, Chang K, Park YW, Song YB, Ahn SG, Suh JW, Lee SY, Cho JR, Her AY, Kim HS, Lim DS, Shin ES, Kim MH; PTRG-DES Consortium Investigators. Prognostic Implication of Platelet Reactivity According to Procedural Complexity After PCI: Subanalysis of PTRG-DES Consortium. JACC Asia. 2023 Dec 26;4(3):185-198. doi: 10.1016/j.jacasi.2023.10.011. eCollection 2024 Mar.

    PubMed 38463677

  • Han D, Kim SH, Shin DG, Kang MK, Choi S, Lee N, Kim BK, Joo HJ, Chang K, Park Y, Song YB, Ahn SG, Suh JW, Lee SY, Her AY, Jeong YH, Kim HS, Kim MH, Lim DS, Shin ES, Cho JR; PTRG Investigator. Prognostic Implication of Platelet Reactivity According to Left Ventricular Systolic Dysfunction Status in Patients Treated With Drug-Eluting Stent Implantation: Analysis of the PTRG-DES Consortium. J Korean Med Sci. 2024 Jan 22;39(3):e27. doi: 10.3346/jkms.2024.39.e27.

    PubMed 38258362

  • Lim S, Hong SJ, Kim JH, Cha JJ, Joo HJ, Park JH, Yu CW, Kim BK, Chang K, Park Y, Song YB, Ahn SG, Suh JW, Lee SY, Cho JR, Her AY, Jeong YH, Kim HS, Kim MH, Shin ES, Lim DS; PTRG Investigators. High platelet reactivity strongly predicts early stent thrombosis in patients with drug-eluting stent implantation. Sci Rep. 2024 Jan 4;14(1):520. doi: 10.1038/s41598-023-50920-9.

    PubMed 38177178

  • Jeon KH, Jeong YH, Chae IH, Kim BK, Joo HJ, Chang K, Park Y, Song YB, Ahn SG, Lee SY, Cho JR, Her AY, Kim HS, Kim MH, Lim DS, Shin ES, Suh JW; PTRG-DES Consortium Investigators. Implication of diabetic status on platelet reactivity and clinical outcomes after drug-eluting stent implantation: results from the PTRG-DES consortium. Cardiovasc Diabetol. 2023 Sep 7;22(1):245. doi: 10.1186/s12933-023-01976-4.

    PubMed 37679760

  • Kim SJ, Her AY, Jeong YH, Kim BK, Joo HJ, Park Y, Chang K, Song YB, Ahn SG, Suh JW, Lee SY, Cho JR, Kim HS, Kim MH, Lim DS, Shin ES; PTRG-DES Consortium Investigators. Sex Differences in Midterm Prognostic Implications of High Platelet Reactivity After Percutaneous Coronary Intervention With Drug-Eluting Stents in East Asian Patients: Results From the PTRG-DES (Platelet Function and Genotype-Related Long-Term Prognosis in Drug-Eluting Stent-Treated Patients With Coronary Artery Disease) Consortium. J Am Heart Assoc. 2023 May 2;12(9):e027804. doi: 10.1161/JAHA.122.027804. Epub 2023 Apr 29.

    PubMed 37119080

  • Lee SH, Jeong YH, Hong D, Choi KH, Lee JM, Park TK, Yang JH, Hahn JY, Choi SH, Gwon HC, Jeong MH, Kim BK, Joo HJ, Chang K, Park Y, Ahn SG, Suh JW, Lee SY, Cho JR, Her AY, Kim HS, Kim MH, Lim DS, Shin ES, Song YB; PTRG-DES Registry Investigators. Clinical Impact of CYP2C19 Genotype on Clopidogrel-Based Antiplatelet Therapy After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2023 Apr 10;16(7):829-843. doi: 10.1016/j.jcin.2023.01.363. Epub 2023 Mar 8.

    PubMed 37045504

  • Lee SJ, Cha JJ, Jeong YH, Hong SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Joo HJ, Chang K, Park Y, Song YB, Ahn SG, Suh JW, Lee SY, Cho JR, Her AY, Kim HS, Kim MH, Shin ES, Lim DS, Kim BK; PTRG Investigators. Platelet Reactivity and Clinical Outcomes After Drug-Eluting Stent Implantation: Results From the PTRG-DES Consortium. JACC Cardiovasc Interv. 2022 Nov 28;15(22):2253-2265. doi: 10.1016/j.jcin.2022.09.007.

    PubMed 36423968

  • 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.

    PubMed 35512743

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Clopidogrel, Poor Metabolism of, run by Gyeongsang National University Hospital 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 4 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 31 Mar 2022. 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?

MACCE (time frame: upto 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04734028, which also lists 15 linked publications.

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 31 Mar 2022.

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