Recurrent Events After Percutaneous Coronary INterventio for ACS

• Conditions: Acute Coronary Syndrome; Coronary Artery Disease

• Registration Number: NCT03675347
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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.

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-15
• Last Update Submitted: 2018-09-15
• Study First Posted: 2018-09-18
• Last Update Posted: 2018-09-18
• Study Start: 2018-10-01
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of recurrent bleeding and ischemic events after PCI for ACS	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).

Trial Locations

Locations (1)

San Giovanni Battista; 🇮🇹 Torino, Italy