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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Percutaneous Coronary Intervention

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 Type: Observational
• Enrollment (Actual): 977

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 04763
    • Young-Hyo Lim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients 19 years of age or older with acute coronary syndrome (ACS) undergoing PCI for complex coronary lesions using everolimus-eluting stents (Xience®, Abbot corp, Chicago, Illinois, US) and prescribed with s-TDAPT were enrolled in the registry. The enrollment was decided after a patient had undergone PCI and before the patient was discharged from the PCI center

Description

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

Exclusion Criteria:

• cardiogenic shock
• PCI using drug-eluting stents (DES) other than the everolimus-eluting stents
• those who had conditions requiring a long-term oral anticoagulant therapy
• those with life expectancy <1 year

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hanyang University Seoul Hospital
• Collaborators: Abbott; Soon Chun Hyang University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Estimate): February 27, 2023

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; Percutaneous coronary intervention; Low-dose ticagrelor-based dual antiplatelet agent therapy; Complex coronary lesion; Net clinical outcome; Everolimus-eluting stent
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Disease; Coronary Artery Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: RICH_2020-0104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No