Acute Coronary SyndromeNCT04848766
IPD Meta-analysis of De-escalation Treatment Strategy After PCI in ACS
An observational study of Acute Coronary Syndrome and Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Artery Disease
- What is being tested?
- De-escalation Treatment Strategy of dual antiplatelet therapy
- How many people
- 9,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jun 2021to Dec 2021
- How long will I take part?
- 1 Year
- 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
- Adult, Older adult
Study population: As above
Who may be able to join
- Subject must have clinical diagnosis of acute coronary syndrome
Who cannot join
- The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Hyo-Soo Kim, MD, hyosoo@snu.ac.kr
Jeehoon Kang, MD, medikang@gmail.com
About this study
Official title: Comparison of De-escalation Treatment Strategy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome
We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies.
Read the detailed description
This is an individual patient-level data meta-analysis (IPD Meta-analysis). This study population was incorporated from studies that were previoiusly published.
We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies. The electronic search strategy was complemented by manual examination of references cited by included articles, recent reviews, editorials, and meta-analyses. No restrictions were imposed on language, study period, or sample size. The search keywords include "acute coronary syndrome", "ACS", "primary", "percutaneous coronary intervention", "PCI", "de-escalation", "guided", "guide", "antiplatelet", "P2Y12 inhibitor", "P2Y12", "dual antiplatelet therapy", "DAPT".
Articles were included when they met the following prespecified criteria: (1) included the ACS patients who underwent PCI with drug-eluting stent (DES); (2) maintained DAPT for 1 year; (3) de-escalation strategy of DAPT was clearly defined; (4) clinical outcomes, including ischemic and bleeding events, were clearly reported; (5) randomized controlled trials were considered for inclusion. Two independent investigators screened titles and abstracts, identified duplicated studies, performed full-article reviews, and determined the study inclusion. The third investigator supervised the searching process and adjudicated all the disagreements.
After selecting eligible RCTs, we will incorporate all known randomized controlled trials requesting individual patient data from the principal investigator of each trial.
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease
- Being tested
- De-escalation Treatment Strategy of dual antiplatelet therapy
- Keywords
- percutaneous coronary intervention, dual antiplatelet therapy, de-escalation
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-escalation Treatment Strategy of dual antiplatelet therapyDrug
Patients receive de-escalation treatment of dual antiplatelet therapy after percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| De-escalation treatment group | Patients diagnosed as acute coronary syndrome, and who receive de-escalation antiplatelet therapy after percutaneous coronary intervention Receives: Drug: De-escalation Treatment Strategy of dual antiplatelet therapy | |
| Conventional treatment group | Patients diagnosed as acute coronary syndrome, and who receive conventional (non-de-escalation) antiplatelet therapy after percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net adverse clinical and cerebral events (NACCE)
composite of all-cause death, myocardial infarction, coronary revascularization, stroke and major bleeding.
Measured: 1 year after intervention
Secondary outcomes (9)
Composite endpoint of Major adverse cardiovascular outcomes
all-cause mortality, myocardial infarction, coronary revascularization, stroke
Measured: 1 year after intervention
Major Bleeding outcome defined by the Bleeding Academic Research Consortium (BARC) criteria
Bleeding outcomes, defined by the Bleeding Academic Research Consortium criteria
Measured: 1 year after intervention
Individual components of the primary outcome
all-cause mortality
Measured: 1 year after intervention
Individual components of the primary outcome
cardiovascular mortality
Measured: 1 year after intervention
Individual components of the primary outcome
non-cardiovascular mortality
Measured: 1 year after intervention
Individual components of the primary outcome
myocardial infarction
Measured: 1 year after intervention
Individual components of the primary outcome
stroke
Measured: 1 year after intervention
Individual components of the primary outcome
any coronary revascularization
Measured: 1 year after intervention
Individual components of the primary outcome
any bleeding
Measured: 1 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start7 Jun 2021
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 9,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital, Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Hyo-Soo Kim, Seoul National University Hospital
- Investigators
- Kyung Woo Park, MD, PhD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848766
- Sponsor's protocol ID
- De-escal-meta
- Status last verified
- Jun 2021
- First submitted
- 10 Apr 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will be decided after discussed with the principle investigators of each study.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of De-escalation Treatment Strategy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04848766
- Acronym / sponsor ID
- De-escal-meta
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease
- Keywords
- percutaneous coronary intervention, dual antiplatelet therapy, de-escalation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- St. Antonius Hospital, Ludwig-Maximilians - University of Munich
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Apr 2021 (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.
We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies.
Detailed description
This is an individual patient-level data meta-analysis (IPD Meta-analysis). This study population was incorporated from studies that were previoiusly published.
We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies. The electronic search strategy was complemented by manual examination of references cited by included articles, recent reviews, editorials, and meta-analyses. No restrictions were imposed on language, study period, or sample size. The search keywords include "acute coronary syndrome", "ACS", "primary", "percutaneous coronary intervention", "PCI", "de-escalation", "guided", "guide", "antiplatelet", "P2Y12 inhibitor", "P2Y12", "dual antiplatelet therapy", "DAPT".
Articles were included when they met the following prespecified criteria: (1) included the ACS patients who underwent PCI with drug-eluting stent (DES); (2) maintained DAPT for 1 year; (3) de-escalation strategy of DAPT was clearly defined; (4) clinical outcomes, including ischemic and bleeding events, were clearly reported; (5) randomized controlled trials were considered for inclusion. Two independent investigators screened titles and abstracts, identified duplicated studies, performed full-article reviews, and determined the study inclusion. The third investigator supervised the searching process and adjudicated all the disagreements.
After selecting eligible RCTs, we will incorporate all known randomized controlled trials requesting individual patient data from the principal investigator of each trial.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De-escalation treatment group | – | Drug: De-escalation Treatment Strategy of dual antiplatelet therapyPatients diagnosed as acute coronary syndrome, and who receive de-escalation antiplatelet therapy after percutaneous coronary intervention |
| Conventional treatment group | – | –Patients diagnosed as acute coronary syndrome, and who receive conventional (non-de-escalation) antiplatelet therapy after percutaneous coronary intervention |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- As above
Key inclusion criteria (1 listed)
- Subject must have clinical diagnosis of acute coronary syndrome
Key exclusion criteria (1 listed)
- The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| De-escalation Treatment Strategy of dual antiplatelet therapyPatients receive de-escalation treatment of dual antiplatelet therapy after percutaneous coronary intervention | Drug | De-escalation treatment group |
Primary outcome
Net adverse clinical and cerebral events (NACCE)
Time frame: 1 year after intervention
composite of all-cause death, myocardial infarction, coronary revascularization, stroke and major bleeding.
9 secondary outcomes
Composite endpoint of Major adverse cardiovascular outcomes
Time frame: 1 year after intervention
Major Bleeding outcome defined by the Bleeding Academic Research Consortium (BARC) criteria
Time frame: 1 year after intervention
Individual components of the primary outcome
Time frame: 1 year after intervention
Individual components of the primary outcome
Time frame: 1 year after intervention
Individual components of the primary outcome
Time frame: 1 year after intervention
Individual components of the primary outcome
Time frame: 1 year after intervention
Individual components of the primary outcome
Time frame: 1 year after intervention
Individual components of the primary outcome
Time frame: 1 year after intervention
Individual components of the primary outcome
Time frame: 1 year after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: Undecided. Data sharing will be decided after discussed with the principle investigators of each study.
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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.
Kyung Woo Park, MD, PhD study director
Seoul National University Hospital
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 Acute Coronary Syndrome and Coronary Artery Disease, run by Seoul National University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyo-Soo Kim, MD, PhD (82-2-2072-2226, hyosoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net adverse clinical and cerebral events (NACCE) (time frame: 1 year after intervention). 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 8 Jun 2021.