Recurrent Events After Percutaneous Coronary INterventio for ACS

Coronary Artery Disease Clinical Trial

— AGAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03675347
• Other study ID #: AGAIN
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: November 2019

Study information

• Verified date: September 2018
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: dascenzo fabrizio, Doctor
• Phone: 3391390253
• Email: fabrizion.dascenzo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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:

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• angioplasty
angioplasty

Locations

Country	Name	City	State
Italy	San Giovanni Battista	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of recurrent bleeding and ischemic events after PCI for ACS	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).	2018 - 2019