Coronary Artery DiseaseAGAINNCT03675347
Recurrent Events After Percutaneous Coronary INterventio for ACS
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- angioplasty
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2018to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Giovanni Battista
Torino
fabrizio dascenzo, doctor, 3391390253, fabrizio.dascenzo@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Being tested
- angioplasty
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angioplastyOther
angioplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2018 - 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio D'Ascenzo, A.O.U. Città della Salute e della Scienza
- Investigators
- biole carloalberto, doctor, Study chair, Molinette
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675347
- Sponsor's protocol ID
- AGAIN
- Acronym
- AGAIN
- Status last verified
- Sep 2018
- First submitted
- 7 Sep 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Predictors and impAct on General Population of Recurrent Events After Percutaneous Coronary INterventio for ACS: the AGAIN a Multicenter Study
- ClinicalTrials.gov ID
- NCT03675347
- Acronym / sponsor ID
- AGAIN / AGAIN
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| angioplastyangioplasty | Other | – |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
biole carloalberto, doctor study chair
Molinette
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dascenzo fabrizio, Doctor (3391390253, fabrizion.dascenzo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of recurrent bleeding and ischemic events after PCI for ACS (time frame: 2018 - 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.