P2Y12 Inhibitor Utilization in Bifurcation and Chronic Total Occlusion PCI With Multiple DES (P2BiTO) Registry

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by G. d'Annunzio University
Sponsor:
Information provided by (Responsible Party):
Raffaele De Caterina, G. d'Annunzio University
ClinicalTrials.gov Identifier:
NCT01967615
First received: October 17, 2013
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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 DES 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 presence of ≥2 overlapping DES in CTO and bifurcation lesions.


Condition
Coronary Arteriosclerosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: P2Y12 Inhibitor Utilization in Bifurcation and Chronic Total Occlusion Percutaneous Coronary Intervention With Multiple Drug-eluting Stent (P2BiTO) Registry

Resource links provided by NLM:


Further study details as provided by G. d'Annunzio University:

Primary Outcome Measures:
  • Death, Myocardial infarction, Stent Thrombosis [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 1800
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:

All patients aged 18-80 undergoing PCI of a CTO or bifurcating lesion with ≥2 overlapping DES at participating centers and discharged with either prasugrel or ticagrelor will be deemed eligible to enter the registry.

In-hospital outcomes will be recorded; all patients discharged alive will be followed up with a 30-day and 6-month telephone interview and a 1-year visit.

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, 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.

Assuming a 1-year rate of death, myocardial infarction and stent thrombosis of 12% among patients with "overlapping DES" taking ticagrelor, an overall sample size of 578 patients in each group would allow to detect a reduction of 40% in the occurrence of the combined primary end-point among prasugrel as compared to ticagrelor patients. By estimating a 5% drop-off rate during the 1-year follow-up, 603 patients will have to be enrolled in each arm and therefore a total of 1810 patients will be screened in the study.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients aged 18-80 undergoing PCI of a CTO or bifurcating lesion with ≥2 overlapping DES at participating centers and discharged with either prasugrel or ticagrelor will be deemed eligible to enter the registry

Criteria

Inclusion Criteria:

  • Age between 18-80 years old
  • PCI of a CTO or bifurcating lesion with ≥2 overlapping DES
  • Therapy with either prasugrel or ticagrelor

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967615

Contacts
Contact: Raffaele De Caterina, MD/PhD +39 0871 41512 rdecater@unich.it

Sponsors and Collaborators
G. d'Annunzio University
Investigators
Principal Investigator: Marco Zimarino, MD G. d'Annunzio University
  More Information

Publications:
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24.

Responsible Party: Raffaele De Caterina, MD/PhD, G. d'Annunzio University
ClinicalTrials.gov Identifier: NCT01967615     History of Changes
Other Study ID Numbers: P2BiTO13, 2013-100813
Study First Received: October 17, 2013
Last Updated: March 27, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by G. d'Annunzio University:
PCI,
CTO,
bifurcation,
clopidogrel,
prasugrel,
ticagrelor

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases

ClinicalTrials.gov processed this record on July 20, 2014