Status:
UNKNOWN
Dual Antiplatelet Therapy Tailored on the Extent of Platelet Inhibition
Lead Sponsor:
University of Florence
Collaborating Sponsors:
Tuscany Region
Conditions:
Unstable Angina
NSTEMI
Eligibility:
All Genders
20-90 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy (reduction of major ischemic events at 6 and 12 months of follow-up) of a tailored clopidogrel therapy in patients with UA/NSTEMI undergoing PCI w...
Detailed Description
Several studies documented the presence of a high variability in the individual response to antiplatelet therapies in terms of extent of platelet function inhibition. This laboratory finding is the so...
Eligibility Criteria
Inclusion
- Unstable or NSTEMI
Exclusion
- Previous bleeding events which have required blood transfusion
- PT- INR \>1.5
- Platelet count ≤ 100000/ mm3
- Hb \< 10 g/dl
- Previous TIA/stroke (ischemic or hemorrhagic or unknown)
- Body weight \< 60 Kg
- Creatinine levels ≥ 4 mg/dl
- Cerebral neoplasia
- Recent major trauma/surgery/head injury (within 3 previous weeks)
- Gastrointestinal hemorrhage in the last month
- Aortic dissection
- Known haemorrhagic diathesis
- Oral anticoagulant therapy
- Pregnancy or 1 week after delivery
- Uncontrolled hypertension (systolic \>180 mmHg or diastolic \>110 mmHg)
- Severe liver disease
- Infective endocarditis
- Major psychiatric disorders
- Alcool or drug abuse
- Active peptic ulcer Noncompressible arterial puncture within 14 days Prolonged cardiopulmonary resuscitation
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT00774475
Start Date
November 1 2008
End Date
January 1 2011
Last Update
October 24 2008
Active Locations (1)
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1
University of Florence
Florence, Italy, 50134