NCT03675347

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

September 7, 2018

Last Update Submit

September 15, 2018

Conditions

Coronary Artery DiseaseAcute Coronary Syndrome

Outcome Measures

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).

    2018 - 2019

Interventions

angioplastyOTHER

angioplasty

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Giovanni Battista

Torino, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary Syndrome

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • biole carloalberto, doctor

    Molinette

    STUDY CHAIR

Central Study Contacts

dascenzo fabrizio, Doctor

CONTACT

3391390253fabrizion.dascenzo@gmail.com

brustio alessandro, Doctor

CONTACT

0116335570fabrizion.dascenzo@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 18, 2018

Study Start

October 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

September 18, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)