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Recurrent Events After Percutaneous Coronary INterventio for ACS (AGAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675347
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Fabrizio D'Ascenzo, Azienda Ospedaliera Città della Salute e della Scienza di Torino

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.


Condition or disease Intervention/treatment
Coronary Artery Disease Acute Coronary Syndrome Other: angioplasty

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Incidence, Predictors and impAct on General Population of Recurrent Events After Percutaneous Coronary INterventio for ACS: the AGAIN a Multicenter Study
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty


Intervention Details:
  • Other: angioplasty
    angioplasty


Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with Acute Coronary Syndrome (ACS) treated with Percutaneous Coronary Intervention (PCI) who experienced a bleeding or ischemic event during the first year of follow-up
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:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675347


Contacts
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Contact: dascenzo fabrizio, Doctor 3391390253 fabrizion.dascenzo@gmail.com
Contact: brustio alessandro, Doctor 0116335570 fabrizion.dascenzo@gmail.com

Locations
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Italy
San Giovanni Battista Recruiting
Torino, Italy
Contact: fabrizio dascenzo, doctor    3391390253    fabrizio.dascenzo@gmail.com   
Sponsors and Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Investigators
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Study Chair: biole carloalberto, doctor Molinette
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Responsible Party: Fabrizio D'Ascenzo, Director, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier: NCT03675347    
Other Study ID Numbers: AGAIN
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Acute Coronary Syndrome
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases