Transradial access versus Femoral and Bivalirudin versus unfractionated heparin with or without glycoprotein IIb/IIIa inhibitors as a global strategy to minimize bleeding complications in patients with acute coronary syndrome subjected to invasive treatment (MATRIX). - Matrix

Società Italian di Cardiologia Invasiva GISE0 个研究点目标入组 6,800 人开始时间: 2014年6月4日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•All patients with acute coronary syndrome (ACS) with or without ST-segment elevation who undergo angiography coronary ± angioplasty (PCI) and that eligible for treatment with both access sites trans-radial and trans-femoral will be enrolled on consecutive basic.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 6800
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6800

•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.
•11.Treatment with other investigational drugs or devices within the preceding 30 days.
•12.Randomisation or planned use of other investigational drugs or devices in this trial.
•13.Severe uncontrolled hypertension (defined as persistent systolic blood pressure higher than 220 mmHg despite medical treatment).
•14.Subacute bacterial endocarditis.
•15.PCI in the previous 30 days.

发起方

Società Italian di Cardiologia Invasiva GISE