1 / 8

The MATRIX Program

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. Heparin ±GPI. Bivalirudin

gambhiri-naveen
Download Presentation

The MATRIX Program

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. The MATRIX Program NCT01433627 M. Valgimigli, MD, PhD Erasmus MC Thoraxcenter, Rotterdam The Netherlands

  2. MATRIX Program NCT01433627 NSTEACS or STEMI with invasive management Aspirin+P2Y12 blocker 1:1 Trans-Radial Access Trans-Femoral Access 1:1 Heparin ±GPI Bivalirudin Mono-Tx 1:1 Is TRI superior to TFI ? Is Bivalirudin superior to UFH ? Stop Infusion Prolong≥ 4 hs infusion Should Bivalirudin be prolonged after PCI ? http://www.cardiostudy.it/matrix

  3. 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

  4. 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

  5. MATRIX Anti-thombin NCT01433627 NSTEACS or STEMI with invasive management Aspirin+P2Y12 blocker 1:1 Heparin ±GPI Bivalirudin Mono-Tx 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

  6. MATRIX Anti-thombin NCT01433627 NSTEACS or STEMI with invasive management Aspirin+P2Y12 blocker 1:1 Heparin ±GPI Bivalirudin Mono-Tx 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 bleedswithin 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

  7. 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

  8. Recruitment Status August 2014

More Related