Clinical trial NCT04848766: IPD Meta-analysis of De-escalation Treatment Strategy After PCI in ACS
Official title: Comparison of De-escalation Treatment Strategy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Coronary Artery Disease
Keywords: percutaneous coronary intervention
dual antiplatelet therapy
de-escalation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: St. Antonius Hospital
name: Ludwig-Maximilians - University of Munich
First posted: 2021-04-19
Enrollment: 9000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As above

Brief 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 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.

Eligibility criteria: This study is a meta-analysis of previously published studies. Therefore, the eligibility criteria may be diverse according to the individual studies.

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Inclusion Criteria:

* Subject must have clinical diagnosis of acute coronary syndrome

Exclusion Criteria:

* The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor

Primary outcomes:
measure: Net adverse clinical and cerebral events (NACCE)
timeFrame: 1 year after intervention
Secondary outcomes:
measure: Composite endpoint of Major adverse cardiovascular outcomes
timeFrame: 1 year after intervention
measure: Major Bleeding outcome defined by the Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 1 year after intervention
measure: Individual components of the primary outcome
timeFrame: 1 year after intervention
measure: Individual components of the primary outcome
timeFrame: 1 year after intervention
measure: Individual components of the primary outcome
timeFrame: 1 year after intervention
measure: Individual components of the primary outcome
timeFrame: 1 year after intervention
measure: Individual components of the primary outcome
timeFrame: 1 year after intervention
measure: Individual components of the primary outcome
timeFrame: 1 year after intervention
measure: Individual components of the primary outcome
timeFrame: 1 year after intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung Woo Park, MD, PhD
role: STUDY_DIRECTOR
References: