PTRG-DES Consortium

Coronary Artery Disease Clinical Trial

— PTRG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734028
• Other study ID #: PTRG
• Status: Completed
• Start date: July 9, 2003
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2022
• Source: Gyeongsang National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13160
• Est. completion date: June 30, 2020
• Est. primary completion date: August 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Clopidogrel, Poor Metabolism of
• Coronary Artery Disease
• Platelet Dysfunction
• Stent Thrombosis
• Thrombosis

Intervention

Drug:
• Clopidogrel Tablets
DES-treated patients were treated with clopidogrel 75 mg daily and aspirin 100 mg daily

Locations

Country	Name	City	State
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon	Gyeongsangnam-do

Sponsors (2)

Lead Sponsor	Collaborator
Gyeongsang National University Hospital	Korean Society of Interventional Cardiology

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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 Pa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical event according to gender	prognostic implications of PFT, genotype and CRP	upto 10 years
Other	Clinical event according to age	prognostic implications of PFT, genotype and CRP	upto 10 years
Other	Clinical event according to BMI	prognostic implications of PFT, genotype and CRP	upto 10 years
Other	Clinical event according to anemia	prognostic implications of PFT, genotype and CRP	upto 10 years
Other	Clinical event according to DM	prognostic implications of PFT, genotype and CRP	upto 10 years
Other	Clinical event according to CKD	prognostic implications of PFT, genotype and CRP	upto 10 years
Other	Clinical event according to disease entity (AMI vs. non-AMI)	prognostic implications of PFT, genotype and CRP	upto 10 years
Other	Clinical event according to LV dysfunction (LV EF)	prognostic implications of PFT, genotype and CRP	upto 10 years
Other	Clinical event according to complex PCI	prognostic implications of PFT, genotype and CRP	upto 10 years
Other	Clinical event according to time point post-PCI	prognostic implications of PFT, genotype and CRP	upto 10 years
Primary	MACCE	All-cause death, MI, stroke or stent thrombosis	upto 10 years
Secondary	Major bleeding	BARC type 3-5 bleeding	upto 10 years
Secondary	MACE1	CV death, MI and stent thrombosis	upto 10 years
Secondary	MACE2	CV death, MI, stent thrombosis and revascularization	upto 10 years
Secondary	Each clinical event	all-cause death, CV death, MI, stroke, stent thrombosis, revascularization or major bleeding	upto 10 years

External Links

•   Thrombosis and Haemostasis