Transradial access versus Femoral and Bivalirudin versus unfractionated heparin with or without glycoprotein IIb/IIIa inhibitors to verify the bleeding complications in patients with acute coronary syndrome treatment of coronary angioplasty.

Phase 1

• Conditions: Patients with acute coronary syndrome (ACS) with or without ST-segment elevation who undergo CATH ± PCI; MedDRA version: 17.0 Level: LLT Classification code 10071111 Term: Non ST segment elevation acute coronary syndrome System Organ Class: 100000004849; MedDRA version: 17.0 Level: LLT Classification code 10064346 Term: STEMI System Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-000430-11-ES
• Lead Sponsor: Società Italian di Cardiologia Invasiva GISE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-04
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 6800

Inclusion Criteria

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

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 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.

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 the transradial access site or infusion of bivalirudin compared to femoral access or standard therapy consisting of unfractionated heparin and the provisional use of glycoprotein IIb/IIIa inhibitors are associated with a lower incidence of the composite of death, myocardial infarction and stroke within 30 days after randomization in patients with acute coronary syndrome exposed to early invasive treatment.;Secondary Objective: NA;<br> Primary end point(s): Primary Endpoint at 30 days:<br> A composite of death, re-infarction (MI) or stroke<br> ;Timepoint(s) of evaluation of this end point: 30 Days