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

Coronary Artery Disease Clinical Trial

— RICH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05746416
• Other study ID #: RICH_2020-0104
• Status: Completed
• Start date: January 2, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2023
• Source: Hanyang University Seoul Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 977
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Percutaneous Coronary Intervention
• Syndrome

Locations

Country	Name	City	State
Korea, Republic of	Young-Hyo Lim	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Hanyang University Seoul Hospital	Abbott, Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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