EUCTR2011-000430-11-ES
Active, not recruiting
Phase 1
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 sites6,800 target enrollmentJune 4, 2014
ConditionsPatients with acute coronary syndrome (ACS) with or without ST-segment elevation who undergo CATH ± PCIMedDRA version: 17.0 Level: LLT Classification code 10071111 Term: Non ST segment elevation acute coronary syndrome System Organ Class: 100000004849MedDRA version: 17.0 Level: LLT Classification code 10064346 Term: STEMI System Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsAngiox
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with acute coronary syndrome (ACS) with or without ST-segment elevation who undergo CATH ± PCI
- Sponsor
- Società Italian di Cardiologia Invasiva GISE
- Enrollment
- 6800
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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