CClinicalTrials.gg
Status unknownNCT03675347AGAINUpdated Sep 18, 2018

Recurrent Events After Percutaneous Coronary INterventio for ACS

An observational study in Coronary Artery Disease and Acute Coronary Syndrome, sponsored by A.O.U. Città della Salute e della Scienza. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-09-18.

Sponsored by A.O.U. Città della Salute e della Scienza · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

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.

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Conditions studied

  • Coronary Artery Disease
  • Acute Coronary Syndrome
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

A.O.U. Città della Salute e della Scienza is the lead sponsor of 63 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
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

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

Exclusion Criteria:

  • none
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Interventions

  • Otherangioplasty

    angioplasty

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 2018 - 2019

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03675347
Lead sponsor
A.O.U. Città della Salute e della Scienza
Responsible party
Fabrizio D'Ascenzo (Director, A.O.U. Città della Salute e della Scienza) — Principal investigator
First posted
Sep 18, 2018
Start date
Oct 1, 2018 (estimated)
Primary completion
Nov 2019 (estimated)
Completion
Nov 2019 (estimated)
Last update
Sep 18, 2018

Study contacts

dascenzo fabrizio, Doctor
Contact
fabrizion.dascenzo@gmail.com
3391390253
brustio alessandro, Doctor
Contact
fabrizion.dascenzo@gmail.com
0116335570
biole carloalberto, doctor
study chair · Molinette

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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