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Completed

NCT Number: NCT05746416

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Young-Hyo Lim

Seoul, 04763, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. A major adverse cardiac and cerebrovascular event (MACE)

    Time frame: at 1 years after discharge

    a composite of cardiovascular death, non-fetal MI, RR, stent thrombosis and ischemic stroke.

Secondary outcomes

  1. All cause death

    Time frame: at 1 years after discharge

    a death from any cause

  2. cardiovascular death

    Time frame: at 1 years after discharge

    death from MI, stent thrombosis and ischemic stroke

  3. Myocardial infarction

    Time frame: at 1 years after discharge

    the 4th universal definition of MI

  4. Repeat revascularization

    Time frame: at 1 years after discharge

    a new PCI for the target vessels or de-novo coronary lesions

  5. bleeding event

    Time frame: at 1 years after discharge

    the bleeding event equivalent to Bleeding Academic Research Consortium (BARC) classification 2 or higher

  6. A net clinical event (NCE)

    Time frame: at 1 years after discharge

    a composite of MACEs and bleeding events

Sponsors and collaborators

Lead sponsor

Hanyang University Seoul Hospital

Other

Collaborators

  • Abbott
  • Soon Chun Hyang University

Registry information

Official study 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

Acronym: RICH

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 27, 2023
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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