Status:
UNKNOWN
Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX
Lead Sponsor:
Italian Society of Invasive Cardiology
Collaborating Sponsors:
Eustrategy
Conditions:
Acute Coronary Syndromes
STEMI
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This protocol describes a study to compare intended trans-radial versus trans-femoral intervention and bivalirudin monotherapy versus current European standard of care consisting of unfractionated hep...
Detailed Description
The use of combined antithrombotic therapies over the last two decades has decreased the risk of a heart attack after percutaneous coronary intervention substantially but has also been associated with...
Eligibility Criteria
Inclusion
- NSTEACS definition: Patients with all of the following criteria will be eligible:
- history consistent with new, or worsening ischemia, occurring at rest or with minimal activity;
- enrollment within 7 days of the most recent symptoms;
- planned coronary angiography with possible indication to PCI;
- 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;
- STEMI definition: i) 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.
Exclusion
- Patients who can not give informed consent or have a life expectancy of \<30 days
- Allergy/intolerance to Bivalirudin or unfractionated heparin.
- Stable or silent CAD as indication to coronary angiography
- Treatment with LWMH within the past 6 hours
- Treatment with any GPI in the previous 3 days
- Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast or to any of the study medications including aspirin or clopidogrel.
- Contraindications to angiography, including but not limited to severe peripheral vascular disease.
- 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.
- If it is known a creatinine clearance \<30 mL/min or dialysis dependent.
- Previous enrollment in this study.
- Treatment with other investigational drugs or devices within the 30 days preceding
- Randomisation or planned use of other investigational drugs or devices in this trial.
- Severe uncontrolled hypertension (defined as persistent systolic blood pressure higher than 220 mmHg despite medical treatment).
- Subacute bacterial endocarditis
- PCI in the previous 30 days
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
7200 Patients enrolled
Trial Details
Trial ID
NCT01433627
Start Date
October 1 2011
End Date
December 1 2015
Last Update
January 29 2015
Active Locations (62)
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1
Ospedale Clinicizzato SS Annunziata di Chieti
Chieti, Abruzzo, Italy
2
Ospedale Civile Santo Spirito
Pescara, Abruzzo, Italy
3
Ospedale Di Venere - ASL Bari
Bari, Apulia, Italy
4
Città di Lecce Ospedale (GVM)
Lecce, Apulia, Italy