Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of angioX (MATRIX) - MATRIX

Società Italian di Cardiologia Invasiva GISE0 sites92 target enrollmentTBD

Overview

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

January 12, 2016

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Società Italian di Cardiologia Invasiva GISE

•1\. history consistent with new, or worsening ischemia, occurring at rest or with minimal activity;
•2\. enrolment within 7 days of the most recent symptoms;
•3\. planned coronary angiography with possible indication to PCI;
•4\. at least 2 of the following criteria:
•Aged 60 years or older,
•Troponin T or I or creatine kinase MB above the upper limit of normal;
•Electrocardiograph changes compatible with ischemia, ie, ST depression of 1 mm or greater in 2 contiguous leads, T\-wave inversion more than 3 mm, or any dynamic ST shifts.

•1\. Patients who can not give informed consent or have a life expectancy of \<30 days.
•2\. Allergy/intolerance to bivalirudin or unfractionated heparin.
•3\. Stable or silent CAD as indication to coronary angiography.
•4\. Treatment with LWMH within the past 6 hours.
•5\. Treatment with any GPI in the previous 3 days.
•6\. Absolute contraindications or allergy that cannot be pre\-medicated to iodinated contrast or to any of the study medications including both aspirin and clopidogrel.
•7\. Contraindications to angiography, including but not limited to severe peripheral vascular disease.
•8\. If it is known, pregnant or nursing mothers. Women of child\-bearing age will be asked if they are pregnant or think that they may be pregnant.
•9\. If it is known, a creatinine clearance \<30 mL/min or dialysis dependent.
•10\. Previous enrolment in this study.