Coronary Artery DiseaseRICHNCT05746416
Xience Registry In Complex Lesion of Acute Coronary Syndrome Patients witH Ticagrelor (RICH)
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Hanyang University Seoul Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome
- How many people
- 977 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2019to 31 Dec 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Keywords
- Low-dose ticagrelor-based dual antiplatelet agent therapy, Percutaneous coronary intervention, Acute coronary syndrome, Complex coronary lesion, Net clinical outcome, Everolimus-eluting stent
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
A major adverse cardiac and cerebrovascular event (MACE)
a composite of cardiovascular death, non-fetal MI, RR, stent thrombosis and ischemic stroke.
Measured: at 1 years after discharge
Secondary outcomes (6)
All cause death
a death from any cause
Measured: at 1 years after discharge
cardiovascular death
death from MI, stent thrombosis and ischemic stroke
Measured: at 1 years after discharge
Myocardial infarction
the 4th universal definition of MI
Measured: at 1 years after discharge
Repeat revascularization
a new PCI for the target vessels or de-novo coronary lesions
Measured: at 1 years after discharge
bleeding event
the bleeding event equivalent to Bleeding Academic Research Consortium (BARC) classification 2 or higher
Measured: at 1 years after discharge
A net clinical event (NCE)
a composite of MACEs and bleeding events
Measured: at 1 years after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start2 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 977 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Soon Chun Hyang University, Abbott
- Responsible party
- Principal investigator, Young-Hyo Lim, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746416
- Sponsor's protocol ID
- RICH_2020-0104
- Acronym
- RICH
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05746416
- Acronym / sponsor ID
- RICH / RICH_2020-0104
- Keywords
- Low-dose ticagrelor-based dual antiplatelet agent therapy, Percutaneous coronary intervention, Acute coronary syndrome, Complex coronary lesion, Net clinical outcome, Everolimus-eluting stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 977 participants (actual)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Collaborators
- Soon Chun Hyang University, Abbott
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
All cause death
Time frame: at 1 years after discharge
cardiovascular death
Time frame: at 1 years after discharge
Myocardial infarction
Time frame: at 1 years after discharge
Repeat revascularization
Time frame: at 1 years after discharge
bleeding event
Time frame: at 1 years after discharge
A net clinical event (NCE)
Time frame: at 1 years after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Hanyang University Seoul Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A major adverse cardiac and cerebrovascular event (MACE) (time frame: at 1 years after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.