the matrix program m. valgimigli, md, phd erasmus mc thoraxcenter, rotterdam the netherlands...
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The MATRIX Program
M. Valgimigli, MD, PhD
Erasmus MC
Thoraxcenter, Rotterdam
The Netherlands
NCT01433627
1:11:1
1:11:1
NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker
NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker
Trans-Femoral Access
Heparin±GPI
BivalirudinMono-Tx
StopInfusion
Prolong≥ 4 hs infusion
1:11:1
Trans-Radial Access
Is TRI superior to TFI ?
Is Bivalirudin superior to UFH ?
Should Bivalirudin be prolongedafter PCI ?
MATRIX ProgramMATRIX Program NCT01433627
http://www.cardiostudy.it/matrix
1:11:1
NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker
NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker
Trans-Femoral Access
Trans-Radial Access
To demonstrate that trans-radial intervention as compared to femoral access site is associated to lower rate of the composite endpoint of Death, MI or Stroke
within the first 30 days
1° co-Primary Objective
6% vs. 4.2%, β<10%, α: 2.5%: 8,200 patients
Adaptive study Design: sample size (SS) will be increased by the cross-over rate at 70% of planned SS
MATRIX Access siteMATRIX Access siteNCT01433627
1:11:1
NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker
NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker
Trans-Femoral Access
Trans-Radial Access
To demonstrate that trans-radial intervention as compared to femoral access site is associated to lower rate of the composite endpoint of Death, MI, Stroke or
BARC V or III bleeds within the first 30 days
2° co-Primary Objective
9% vs. 6.3%, β: 2%, α; 2.5%: 8,200 patients
MATRIX Access siteMATRIX Access siteNCT01433627
Adaptive study Design: sample size (SS) will be increased by the cross-over rate at 70% of planned SS
1:11:1
NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker
NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker
Heparin±GPI
BivalirudinMono-Tx
MATRIX Anti-thombinMATRIX Anti-thombinNCT01433627
To demonstrate that Bivalirudin as compared to UFH plus provisional GPI is associated to lower rate of the composite endpoint of Death, MI or Stroke within the
first 30 days
1° co-Primary Objective
6% vs. 4.2%, β<15%, α: 2.5%: 6,800 patients
Adaptive study Design: sample size (SS) will be increased by the cross-over rate at 70% of planned SS
1:11:1
NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker
NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker
Heparin±GPI
BivalirudinMono-Tx
MATRIX Anti-thombinMATRIX Anti-thombinNCT01433627
To demonstrate that Bivalirudin as compared to UFH plus provisional GPI is associated to lower rate of the composite endpoint of Death, MI, Stroke or or BARC V
or III bleeds within the first 30 days
2° co-Primary Objective
9% vs. 6.3%, β<5%, α: 2.5%: 6,800 patients
Adaptive study Design: sample size (SS) will be increased by the cross-over rate at 70% of planned SS
NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker
NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker
BivalirudinMono-Tx
StopInfusion
Prolong≥ 4 hs infusion
1:11:1
MATRIX Treatment durationMATRIX Treatment durationNCT01433627
To demonstrate that prolonged Bivalirudin infusion is associated to lower rate of the composite endpoint of
Death, MI, Stroke, urgent TVR, Stent thrombosis or BARC bleeds V or III within the first 30 days
Primary Objective
10% vs. 7%, β<4%, α:5%: 3,400 patients
Recruitment Status August 2014
Recruitment Status August 2014