Xience Registry In Complex Lesion of Acute Coronary Syndrome Patients witH Ticagrelor (RICH)

Sponsor

Hanyang University Seoul Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05746416

Collaborator

Soon Chun Hyang University (Other), Abbott (Industry)

977

Enrollment

Location

35.9

Actual Duration (Months)

27.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this multicenter prospective clinical cohort study is to investigate the impact of early use of low-dose Ticagrelor-based dual antiplatelet agent therapy (TDAPT) (ticagrelor 120mg daily; l-TDAPT) as compared to standard-dose TDAPT (ticagrelor 180mg daily; s-TDAPT) in outcomes of percutaneous coronary intervention (PCI).

The main question it aims to answer are:

Given the low ischemic risk and high bleeding tendency in Asians, the low dose TDAPT may provide better net clinical benefits of ischemic and bleeding events than the standard dose TDAPT.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Percutaneous Coronary Intervention Acute Coronary Syndrome

Detailed Description

Participants were administrated with 300mg of Aspirin and 180mg of ticagrelor orally before they underwent index PCI, and were prescribed with s-TDAPT from the next day after index PCI at least for 1 week. The start of l-TDAPT was decided by each attending physician's preference.

Successful PCI was defined as a residual stenosis <30% with Thrombolysis in Myocardial Infarction grade 3 flow after PCI and the absence of death by MI and reintervention for the index coronary lesions during the admission period. Standard definitions of cardiovascular events were used for all clinical events. Myocardial infarction (MI) was defined using the 4th universal definition of MI as previously described. Repeat revascularization (RR) was defined as a new PCI for the target vessels or de-novo coronary lesions. All-cause death was defined as a death from any cause. Cardiovascular death was defined as death from MI, stent thrombosis and ischemic stroke. A major adverse cardiac and cerebrovascular event (MACE) was defined as a composite of cardiovascular death, non-fetal MI, RR, stent thrombosis and ischemic stroke. A bleeding event was defined as the bleeding event equivalent to Bleeding Academic Research Consortium (BARC) classification 2 or higher. A net clinical event (NCE) was defined as a composite of MACEs and bleeding events. Patients were scheduled to follow up to 2 years after index PCI. Clinical follow-up started when a patient discharged from the hospitalization for the index PCI and ended when the patient experienced the any clinical event or reached the end of follow-up. The follow-up visits were scheduled at 1, 3 and 6 months, 1 year and 2 years after discharge.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

977 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Xience Registry Study for the Impact of Early Use of Low-Dose Ticagrelor-Based Dual Antiplatelet Therapy to Clinical Outcomes in Patient Undergoing Percutaneous Coronary Interventions for Complex Lesions

Actual Study Start Date :

Jan 2, 2019

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
s-TDAPT group Ticagrelor 180mg + Aspirin 100mg within 6 months after index PCI
l-TDAPT group Ticagrelor 120mg + Aspirin 100mg within 6 months after index PCI

Outcome Measures

Primary Outcome Measures

A major adverse cardiac and cerebrovascular event (MACE) [at 1 years after discharge]
a composite of cardiovascular death, non-fetal MI, RR, stent thrombosis and ischemic stroke.

Secondary Outcome Measures

All cause death [at 1 years after discharge]
a death from any cause
cardiovascular death [at 1 years after discharge]
death from MI, stent thrombosis and ischemic stroke
Myocardial infarction [at 1 years after discharge]
the 4th universal definition of MI
Repeat revascularization [at 1 years after discharge]
a new PCI for the target vessels or de-novo coronary lesions
bleeding event [at 1 years after discharge]
the bleeding event equivalent to Bleeding Academic Research Consortium (BARC) classification 2 or higher
A net clinical event (NCE) [at 1 years after discharge]
a composite of MACEs and bleeding events

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

19 years of age or older
acute coronary syndrome (ACS) undergoing PCI
PCI for complex coronary lesions using everolimus-eluting stents (Xience®, Abbot corp, Chicago, Illinois, US)
prescribed with s-TDAPT for more than 3 months