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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome
• Intervention / Treatment: Drug: De-escalation Treatment Strategy of dual antiplatelet therapy

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 Type: Observational
• Enrollment (Anticipated): 9000

Contacts and Locations

• Study Contact: Name: Jeehoon Kang, MD; Phone Number: 82-2-2072-2677; Email: medikang@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hyo-Soo Kim, MD; Email: hyosoo@snu.ac.kr
    • Contact: Jeehoon Kang, MD; Email: medikang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

As above

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
De-escalation treatment group; Patients diagnosed as acute coronary syndrome, and who receive de-escalation antiplatelet therapy after percutaneous coronary intervention	Drug: De-escalation Treatment Strategy of dual antiplatelet therapy; Patients receive de-escalation treatment of dual 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint of Major adverse cardiovascular outcomes	all-cause mortality, myocardial infarction, coronary revascularization, stroke	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	1 year after intervention
Individual components of the primary outcome	all-cause mortality	1 year after intervention
Individual components of the primary outcome	cardiovascular mortality	1 year after intervention
Individual components of the primary outcome	non-cardiovascular mortality	1 year after intervention
Individual components of the primary outcome	myocardial infarction	1 year after intervention
Individual components of the primary outcome	stroke	1 year after intervention
Individual components of the primary outcome	any coronary revascularization	1 year after intervention
Individual components of the primary outcome	any bleeding	1 year after intervention

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Ludwig-Maximilians - University of Munich; ST. Antonius hospital Nieuwegein
• Investigators: Study Director: Kyung Woo Park, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 10, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; dual antiplatelet therapy; de-escalation
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Disease; Coronary Artery Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: De-escal-meta

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data sharing will be decided after discussed with the principle investigators of each study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No