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

Last updated: June 7, 2021
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Cardiac Ischemia

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT04848766
De-escal-meta
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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


Inclusion Criteria:

  • Subject must have clinical diagnosis of acute coronary syndrome

Exclusion

Exclusion Criteria:

  • The patient has a known hypersensitivity or contraindication to any of the followingmedications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor

Study Design

Total Participants: 9000
Study Start date:
June 07, 2021
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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