NCT01477775

Brief Summary

A subset of patients recruited in the main MATRIX study will be randomized after intervention but before discharge to standard of care (the treating physician will decide which oral P2Y12 inhibitor will be added on top of aspirin) versus a customized approach based on an algorithm which integrates phenotypic information, including but not limited to residual on-treatment platelet reactivity assessed via VerifyNow P2Y12 Assay.

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
4,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Geographic Reach
1 country

11 active sites

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

October 27, 2011

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 3, 2014

Status Verified

September 1, 2014

Enrollment Period

2.9 years

First QC Date

October 27, 2011

Last Update Submit

September 1, 2014

Conditions

Acute Coronary SyndromeCoronary Angioplasty

Keywords

myocardial infarctioncoronary stentOral P2Y12 receptor blockerPlatelet reactivity units (PRU)

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular death, myocardial infarction, stroke or BARC defined bleeding type 2, 3 or 5

    The time to first occurrence of any of the variables listed above will be reported as primary study outcome.

    1 year

  • Proportion of patients in the therapeutic range for residual P2Y12 pathway activity according to PRU values.

    We expect that the prospective use of the previously generated combined phenotype and genotype algorithm will result in an higher proportion of patients being in the therapeutic range with respect to the P2Y12 residual activity (70%) as compared to patients in who the P2Y12 inhibitor is left to the discretion of the treating physician. The first 320 patients recruited in the present study will participate into this mechanistic sub-study.

    30 days

Secondary Outcomes (9)

  • Overall death

    1

  • cardiovascular death

    1 year

  • myocardial infarction

    1 year

  • stroke

    1 year

  • BARC bleeding type 2

    1 year

  • +4 more secondary outcomes

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

The treating physician will be left free to give the oral P2Y12 receptor blocker, including clopidogrel,prasugrel or ticagrelor, which according to his/her clinical judgement is most appropriate for the individual patient.

Drug: Oral P2Y12 receptor blocker

Customized choice of the oral P2Y12 receptor blocker

EXPERIMENTAL

The choice of the oral P2Y12 receptor blocker will be based on an algorithm which integrates phenotype information, including but not limited to residual on-treatment platelet reactivity assessed via Verifynow P2Y12 assay.

Drug: Customized choice for the oral P2Y12 receptor blocker

Interventions

Oral P2Y12 receptor blockerDRUG

Free choice among clopidogrel, prasugrel or ticagrelor

Standard of Care
Customized choice for the oral P2Y12 receptor blockerDRUG

one drug among clopidogrel, prasugrel or ticagrelor based on an algorithm integrating phenotype information.

Customized choice of the oral P2Y12 receptor blocker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients recruited in the main MATRIX study who underwent coronary angioplasty with stent placement.

You may not qualify if:

  • unwillingness to sign this sub study specific informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Azienda Ospedaliera Pugliese Ciaccio

Catanzaro, Calabria, 88100, Italy

ACTIVE NOT RECRUITING

University Hospital of Ferrara

Ferrara, Ferrara, 44100, Italy

RECRUITING

Azienda Ospedaliera Fatebenefratelli e Oftalmico

Milan, MI, 20121, Italy

RECRUITING

Spedali Civili di Brescia

Brescia, Italy

ACTIVE NOT RECRUITING

Azienda USL Sirai

Carbonia, Italy

RECRUITING

Ospedale di Lodi

Lodi, Italy

ACTIVE NOT RECRUITING

Ospedale dei Colli, Cardiologia SUN

Naples, Italy

RECRUITING

Ospedale degli Infermi di Rimini

Rimini, Italy

RECRUITING

Ospedale San Giovanni Bosco

Torino, Italy

RECRUITING

A. O. Ospedale Civile di Vimercate

Vimercate, Italy

RECRUITING

Policlinico San Marco

Zingonia, Italy

RECRUITING

Related Publications (4)

  • Campo G, Parrinello G, Ferraresi P, Lunghi B, Tebaldi M, Miccoli M, Marchesini J, Bernardi F, Ferrari R, Valgimigli M. Prospective evaluation of on-clopidogrel platelet reactivity over time in patients treated with percutaneous coronary intervention relationship with gene polymorphisms and clinical outcome. J Am Coll Cardiol. 2011 Jun 21;57(25):2474-83. doi: 10.1016/j.jacc.2010.12.047.

    PMID: 21679849BACKGROUND

  • Campo G, Ferraresi P, Marchesini J, Bernardi F, Valgimigli M. Relationship between paraoxonase Q192R gene polymorphism and on-clopidogrel platelet reactivity over time in patients treated with percutaneous coronary intervention. J Thromb Haemost. 2011 Oct;9(10):2106-8. doi: 10.1111/j.1538-7836.2011.04457.x. No abstract available.

    PMID: 21819538BACKGROUND

  • Campo G, Miccoli M, Tebaldi M, Marchesini J, Fileti L, Monti M, Valgimigli M, Ferrari R. Genetic determinants of on-clopidogrel high platelet reactivity. Platelets. 2011;22(6):399-407. doi: 10.3109/09537104.2011.579648. Epub 2011 May 31.

    PMID: 21627411BACKGROUND

  • Valgimigli M, Campo G, de Cesare N, Meliga E, Vranckx P, Furgieri A, Angiolillo DJ, Sabate M, Hamon M, Repetto A, Colangelo S, Brugaletta S, Parrinello G, Percoco G, Ferrari R; Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel (3T/2R) Investigators. Intensifying platelet inhibition with tirofiban in poor responders to aspirin, clopidogrel, or both agents undergoing elective coronary intervention: results from the double-blind, prospective, randomized Tailoring Treatment with Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel study. Circulation. 2009 Jun 30;119(25):3215-22. doi: 10.1161/CIRCULATIONAHA.108.833236. Epub 2009 Jun 15.

    PMID: 19528337BACKGROUND

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Marco Valgimigli, MD, PhD

    University Hospital of Ferrara

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Valgimigli, MD, PhD

CONTACT

3356478877vlgmrc@unife.it

Maria Salomone, MD

CONTACT

3357378767m.salomone@dimensione-ricerca.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2011

First Posted

November 23, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

September 3, 2014

Record last verified: 2014-09

Locations

IT(11)