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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05746416
Acronym
RICH
Enrollment
977
Registered
2023-02-27
Start date
2019-01-02
Completion date
2021-12-31
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Coronary Artery Disease, Percutaneous Coronary Intervention

Keywords

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

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.

Interventions

None listed

Sponsors

Soon Chun Hyang University
CollaboratorOTHER
Abbott
CollaboratorINDUSTRY
Hanyang University Seoul Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
cardiovascular deathat 1 years after dischargedeath from MI, stent thrombosis and ischemic stroke
Myocardial infarctionat 1 years after dischargethe 4th universal definition of MI
All cause deathat 1 years after dischargea death from any cause
bleeding eventat 1 years after dischargethe bleeding event equivalent to Bleeding Academic Research Consortium (BARC) classification 2 or higher
A net clinical event (NCE)at 1 years after dischargea composite of MACEs and bleeding events
Repeat revascularizationat 1 years after dischargea new PCI for the target vessels or de-novo coronary lesions

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026