Minimizing Adverse haemmhorragic events by TRansradial access site and systemic Implementation of AngioX

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 6800

Inclusion Criteria

Patients with all of the following criteria will be eligible: (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: 1. Aged 60 years or older, 2. Troponin T or I or creatine kinase MB above the upper limit of normal; 3. 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; (5)chest pain for >20 min with an electrocardiographic ST-segment elevation =1 mm in two or more contiguous electrocardiogram (ECG) leads, or with a new left bundle-branch block, or an infero-lateral myocardial infarction (MI) with ST segment depression of =1 mm in =2 of leads V1-3 with a positive terminal T wave and ii) admission either within 12 h of symptom onset or between 12 and 24 h after onset with evidence of continuing ischemia or previous lytic treatment. To be included in the study all patients should receive as soon as logistically feasible a European Society of Cardiology (ESC) guideline recommended dose of: • Aspirin at an initial dose of 150-325 mg orally (or 250-500 mg IV) followed by 75-100 mg/day for at least 1 year. • A P2Y12 receptor blocker such as clopidogrel at a loading dose of 600 mg followed by 75 mg daily or prasugrel at a lading dose of 60 mg followed by 10 or 5 mg daily or ticagrelor (if and when commercially available) at a loading dose of 180 mg followed by 90 mg b.i.d daily. This should be continued as per ESC guidelines (preferably for one year) in all patients. Enrolment of patients will be stratified based on type of ACS (STEMI vs NSTEMI-troponin positive vs. NSTEACS-troponin negative), Intended or ongoing use of prasugrel and final treatment (i.e. PCI vs. non PCI).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

Exclusion Criteria

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 aspirin or 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 30 days preceding 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main 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 after randomization in acute coronary syndrome patients undergoing early invasive management. 2) To demonstrate that bivalirudin infusion as compared to standard of care therapy consisting of unfractionated heparin and provisional use of glycoprotein IIb/IIIa inhibitors are associated to lower rate of the composite endpoint of death, MI or stroke within the first 30 days after randomization in acute coronary syndrome patients undergoing early invasive management.;Secondary Objective: ;Primary end point(s): A composite of death, re-infarction (MI) or stroke;Timepoint(s) of evaluation of this end point: 30 Days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): A composite of death, non-fatal MI, stroke or BARC-defined type 3 and 5 major bleeding complications at 30 days.;Timepoint(s) of evaluation of this end point: 30 days and 1 year