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Completed

NCT Number: NCT04734028

PTRG-DES Consortium

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Clopidogrel, Poor Metabolism of Coronary Disease Heart Diseases Inflammation Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Platelet Dysfunction Stent Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gyeongsang National University Changwon Hospital

Changwon, Gyeongsangnam-do, 51472, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Clopidogrel Tablets

Drug

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

Other names: aspirin

Primary outcomes

  1. MACCE

    Time frame: upto 10 years

    All-cause death, MI, stroke or stent thrombosis

Secondary outcomes

  1. Major bleeding

    Time frame: upto 10 years

    BARC type 3-5 bleeding

  2. MACE1

    Time frame: upto 10 years

    CV death, MI and stent thrombosis

  3. MACE2

    Time frame: upto 10 years

    CV death, MI, stent thrombosis and revascularization

  4. Each clinical event

    Time frame: upto 10 years

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

Other outcomes

  1. Clinical event according to gender

    Time frame: upto 10 years

    prognostic implications of PFT, genotype and CRP

  2. Clinical event according to age

    Time frame: upto 10 years

    prognostic implications of PFT, genotype and CRP

  3. Clinical event according to BMI

    Time frame: upto 10 years

    prognostic implications of PFT, genotype and CRP

  4. Clinical event according to anemia

    Time frame: upto 10 years

    prognostic implications of PFT, genotype and CRP

  5. Clinical event according to DM

    Time frame: upto 10 years

    prognostic implications of PFT, genotype and CRP

  6. Clinical event according to CKD

    Time frame: upto 10 years

    prognostic implications of PFT, genotype and CRP

  7. Clinical event according to disease entity (AMI vs. non-AMI)

    Time frame: upto 10 years

    prognostic implications of PFT, genotype and CRP

  8. Clinical event according to LV dysfunction (LV EF)

    Time frame: upto 10 years

    prognostic implications of PFT, genotype and CRP

  9. Clinical event according to complex PCI

    Time frame: upto 10 years

    prognostic implications of PFT, genotype and CRP

  10. Clinical event according to time point post-PCI

    Time frame: upto 10 years

    prognostic implications of PFT, genotype and CRP

Sponsors and collaborators

Lead sponsor

Gyeongsang National University Hospital

Other

Collaborators

  • Korean Society of Interventional Cardiology

Registry information

Official study title

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

Acronym: PTRG

Important dates

Study start
2003
Primary completion
2018
Study completion
2020
First posted
Feb 2, 2021
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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