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Clinical Trials/NCT03675347
NCT03675347
Unknown
N/A

Incidence, Predictors and impAct on General Population of Recurrent Events After Percutaneous Coronary INterventio for ACS: the AGAIN a Multicenter Study

A.O.U. Città della Salute e della Scienza1 site in 1 country2,000 target enrollmentOctober 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
A.O.U. Città della Salute e della Scienza
Enrollment
2000
Locations
1
Primary Endpoint
Rates of recurrent bleeding and ischemic events after PCI for ACS
Last Updated
7 years ago

Overview

Brief Summary

Patients undergoing PCI for ACS are exposed to a significant ischemic and bleeding risk.

The aim of our study is instead to analyze in detail the rates of recurrent events, but also their predictors and impact on outcomes, in a population of unselected real life patients treated with PCI for ACS discharged on either Clopidogrel, Prasugrel or Ticagrelor who already experienced an adverse event during the first year of follow up.

Detailed Description

Patients undergoing PCI for ACS are exposed to a significant ischemic and bleeding risk. The rate, predictors and outcomes of an adverse event in this population has been already investigated. However, to the best of our knowledge, only two papers took specifically in analysis rates of recurrence after a first event; the first is a recently published article by Giustino et al; it took in consideration recurrent events in a selected population of patients with ST-elevation Myocardial Infarction (STEMI) participating in the HORIZONS-AMI Trial, discharged on Aspirin and Clopidogrel, analyzing their incidence in the first year of follow-up. The second is a paper by Fanaroff et al which primarily focused on the factors leading to a DAPT intensification in patients with recurrent events. The aim of our study is instead to analyze in detail the rates of recurrent events, but also their predictors and impact on outcomes, in a population of unselected real life patients treated with PCI for ACS discharged on either Clopidogrel, Prasugrel or Ticagrelor who already experienced an adverse event during the first year of follow up.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
November 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
A.O.U. Città della Salute e della Scienza
Responsible Party
Principal Investigator
Principal Investigator

Fabrizio D'Ascenzo

Director

A.O.U. Città della Salute e della Scienza

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria in the present study was the occurrence of an adverse event (bleeding or ischemic) during DAPT therapy in the follow-up after PCI for ACS

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Rates of recurrent bleeding and ischemic events after PCI for ACS

Time Frame: 2018 - 2019

Bleedings events are defined as type 2-5 according to the Bleeding Academic Research Consortium (BARC) definition. Ischemic events are defined as myocardial infarction (MI) and definite stent thrombosis (ST).

Study Sites (1)

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