- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03675347
Recurrent Events After Percutaneous Coronary INterventio for ACS (AGAIN)
Incidence, Predictors and impAct on General Population of Recurrent Events After Percutaneous Coronary INterventio for ACS: the AGAIN a Multicenter Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: dascenzo fabrizio, Doctor
- Phone Number: 3391390253
- Email: fabrizion.dascenzo@gmail.com
Study Contact Backup
- Name: brustio alessandro, Doctor
- Phone Number: 0116335570
- Email: fabrizion.dascenzo@gmail.com
Study Locations
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-
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Torino, Italy
- Recruiting
- San Giovanni Battista
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Contact:
- fabrizio dascenzo, doctor
- Phone Number: 3391390253
- Email: fabrizio.dascenzo@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
2018 - 2019
|
Collaborators and Investigators
Investigators
- Study Chair: biole carloalberto, doctor, Molinette
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGAIN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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