1. No category

The MATRIX Program
NCT01433627
M. Valgimigli, MD, PhD
Erasmus MC
Thoraxcenter, Rotterdam
The Netherlands
MATRIX Program
NCT01433627
NSTEACS or STEMI with invasive management
Aspirin+P2Y12 blocker
1:1
Trans-Radial
Access
Trans-Femoral
Access
1:1
Bivalirudin
Heparin
Mono-Tx
±GPI
1:1
Is TRI superior to TFI ?
Stop
Infusion
Prolong≥ 4 hs
infusion
http://www.cardiostudy.it/matrix
Is Bivalirudin superior to UFH ?
Should Bivalirudin be prolonged
after PCI ?
MATRIX Access site
NCT01433627
NSTEACS or STEMI with invasive management
Aspirin+P2Y12 blocker
1:1
Trans-Radial
Access
Trans-Femoral
Access
1° co-Primary Objective
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
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 site
NCT01433627
NSTEACS or STEMI with invasive management
Aspirin+P2Y12 blocker
1:1
Trans-Radial
Access
Trans-Femoral
Access
2° co-Primary Objective
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
9% vs. 6.3%, β: 2%, 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 Anti-thombin
NCT01433627
NSTEACS or STEMI with invasive management
Aspirin+P2Y12 blocker
1:1
Bivalirudin
Heparin
Mono-Tx
±GPI
1° co-Primary Objective
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
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
MATRIX Anti-thombin
NCT01433627
NSTEACS or STEMI with invasive management
Aspirin+P2Y12 blocker
1:1
Bivalirudin
Heparin
Mono-Tx
±GPI
2° co-Primary Objective
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
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
MATRIX Treatment duration
NSTEACS or STEMI with invasive management
Aspirin+P2Y12 blocker
NCT01433627
Bivalirudin
Mono-Tx
1:1
Stop
Infusion
Prolong≥ 4 hs
infusion
Primary Objective
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
10% vs. 7%, β<4%, α:5%: 3,400 patients
Recruitment Status August 2014