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Completed

NCT Number: NCT01967615

P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI

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.

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Key information

Conditions

Coronary Arteriosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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:

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

Sample size 3150 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Death, Myocardial infarction, Stent Thrombosis

    Time frame: 30 months

    • Death from any cause.
    • 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.
    • Stent thrombosis, defined as definite, probable or possible3 following the Academic Research Consortium

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

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

Acronym: P2BiTO

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Oct 23, 2013
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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