PTRG-DES Consortium

Completed

• Conditions: Coronary Artery Disease; Stent Thrombosis; Clopidogrel, Poor Metabolism of; Platelet Dysfunction
• Interventions: Drug: Clopidogrel Tablets

• Registration Number: NCT04734028
• Lead Sponsor: Gyeongsang National University Hospital

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.

Study Timeline

• Study Start: 2003-07-09
• Primary Completion: 2018-08-07
• Study Completion: 2020-06-30
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-02-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13160

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PTRG-DES registry	Clopidogrel Tablets	After DES implantation, CAD patients were treated with DAPT with clopidogrel and aspirin. During hospitalization, their platelet function, genotype and inflammation biomarker were evaluated.

Primary Outcome Measures

Name	Time	Method
MACCE	upto 10 years	All-cause death, MI, stroke or stent thrombosis

Secondary Outcome Measures

Name	Time	Method
MACE1	upto 10 years	CV death, MI and stent thrombosis
Each clinical event	upto 10 years	all-cause death, CV death, MI, stroke, stent thrombosis, revascularization or major bleeding
MACE2	upto 10 years	CV death, MI, stent thrombosis and revascularization
Major bleeding	upto 10 years	BARC type 3-5 bleeding

Trial Locations

Locations (1)

Gyeongsang National University Changwon Hospital; 🇰🇷 Changwon, Gyeongsangnam-do, Korea, Republic of