IPD Meta-analysis of De-escalation Treatment Strategy After PCI in ACS

Coronary Artery Disease Clinical Trial

Official title:

Comparison of De-escalation Treatment Strategy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04848766
• Other study ID #: De-escal-meta
• Status: Recruiting
• Start date: June 7, 2021
• Est. completion date: December 2021

Study information

• Verified date: June 2021
• Source: Seoul National University Hospital
• Contact: Hyo-Soo Kim, MD, PhD
• Phone: 82-2-2072-2226
• Email: hyosoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 websites were searched for pertinent published studies.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9000
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Syndrome

Intervention

Drug:
• De-escalation Treatment Strategy of dual antiplatelet therapy
Patients receive de-escalation treatment of dual antiplatelet therapy after percutaneous coronary intervention

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ludwig-Maximilians - University of Munich, ST. Antonius hospital Nieuwegein

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net adverse clinical and cerebral events (NACCE)	composite of all-cause death, myocardial infarction, coronary revascularization, stroke and major bleeding.	1 year after intervention
Secondary	Composite endpoint of Major adverse cardiovascular outcomes	all-cause mortality, myocardial infarction, coronary revascularization, stroke	1 year after intervention
Secondary	Major Bleeding outcome defined by the Bleeding Academic Research Consortium (BARC) criteria	Bleeding outcomes, defined by the Bleeding Academic Research Consortium criteria	1 year after intervention
Secondary	Individual components of the primary outcome	all-cause mortality	1 year after intervention
Secondary	Individual components of the primary outcome	cardiovascular mortality	1 year after intervention
Secondary	Individual components of the primary outcome	non-cardiovascular mortality	1 year after intervention
Secondary	Individual components of the primary outcome	myocardial infarction	1 year after intervention
Secondary	Individual components of the primary outcome	stroke	1 year after intervention
Secondary	Individual components of the primary outcome	any coronary revascularization	1 year after intervention
Secondary	Individual components of the primary outcome	any bleeding	1 year after intervention