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

NCT ID: NCT05746416

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 977 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2021-12-31

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.

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.

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention; Acute Coronary Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

s-TDAPT group

Ticagrelor 180mg + Aspirin 100mg within 6 months after index PCI

No interventions assigned to this group

l-TDAPT group

Ticagrelor 120mg + Aspirin 100mg within 6 months after index PCI

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soon Chun Hyang University

OTHER

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: collaborator

Hanyang University Seoul Hospital

OTHER

Sponsor Role: lead

Responsible Party

Young-Hyo Lim

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Young-Hyo Lim

Seoul, , South Korea

Countries

South Korea

Other Identifiers

RICH_2020-0104

Identifier Type: -

Identifier Source: org_study_id