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

NCT05746416 | Completed

• 1 other identifier: RICH_2020-0104
• Study Type: observational
• Target: 977
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention; Acute Coronary Syndrome

Keywords

Low-dose ticagrelor-based dual antiplatelet agent therapy; Percutaneous coronary intervention; Acute coronary syndrome; Complex coronary lesion; Net clinical outcome; Everolimus-eluting stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• All cause death

  at 1 years after discharge

• cardiovascular death

  at 1 years after discharge

• Myocardial infarction

  at 1 years after discharge

• Repeat revascularization

  at 1 years after discharge

• bleeding event

  at 1 years after discharge

Study Arms (2)

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanyang University Seoul Hospital: lead
• Soon Chun Hyang University: collaborator
• Abbott: collaborator

Study Sites (1)

Young-Hyo Lim

Seoul, 04763, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 27, 2023
• Study Start: January 2, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

KR (1)