P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI (P2BiTO)

October 26, 2017 updated by: Raffaele De Caterina, G. d'Annunzio University

P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI With Biologically Active Stents (P2BiTO) Registry

Prasugrel and ticagrelor were both associated with a significant reduction in the risk of MACE in patients undergoing PCI for an ACS, mostly through a reduced stent thrombosis. The 1-year relative risk reduction (RRR) of definite of probable stent thrombosis in patients receiving a DES were fairly different in TRITON-TIMI 38 and PLATO trials. The incidence of "biologically active" stent (DES or BVS) thrombosis is largely variable according to different lesion settings. We aim to verify the translation of the postulated different reduction in thrombosis rate among various P2Y12 inhibitors (clopidogrel, prasugrel and ticagrelor) in a high-risk setting such as the PCI with DES or BVS in CTO and bifurcating lesions.

Study Overview

Status

Completed

Conditions

Detailed Description

All patients aged 18-80 who underwent PCI of a CTO or bifurcating lesion (all Medina types, side branch ≥2 mm) with "biologically active stents" (DES or BVS) between January 2012 and december 2014 at participating centers will be deemed eligible to enter the registry.

In-hospital outcomes will be recorded; all patients discharged alive will be followed up with a telephone interview (minimum follow-up 6 months).

The primary end-point will be the occurrence of a cluster of major adverse cardiovascular events at 1 year:

  1. Death from any cause.
  2. Myocardial infarction.
  3. Stent thrombosis, defined as definite, probable or possible following the Academic Research Consortium.

Sample size 3150 patients.

Study Type

Observational

Enrollment (Actual)

4500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients aged 18-80 undergoing PCI of a CTO or bifurcating lesion (all Medina types, side branch ≥2 mm) with "biologically active stents" (DES or BVS) between January 2012 and december 2014 at participating centers will be deemed eligible to enter the registry.

Description

Inclusion Criteria:

  • Age between 18-80 years old
  • PCI of a CTO or bifurcating lesion (all Medina types, side branch ≥2 mm) with "biologically active stents"

Exclusion Criteria:

-none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death, Myocardial infarction, Stent Thrombosis
Time Frame: 30 months
  1. Death from any cause.
  2. Myocardial infarction, defined as an elevation of the creatine kinase MB fraction or cardiac troponins by a factor of 3 or more, or the development of new Q waves in 2 or more contiguous leads at surface ECG7. Levels of total creatine kinase and the creatine kinase MB fraction will be measured in all patients between 12 and 24 hours after PCI.
  3. Stent thrombosis, defined as definite, probable or possible3 following the Academic Research Consortium
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G. d'Annunzio University

Investigators

  • Principal Investigator: Marco Zimarino, MD, G. d'Annunzio University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 23, 2013

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2BiTO13
  • 2013-100813 (Registry Identifier: P2BiTO)

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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