Dual Antiplatelet Therapy Tailored on the Extent of Platelet Inhibition

• Status: Unknown status
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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 with stent implantation and wiht a documented residual platelet reactivity assessed by a point of care system (VerifyNow P2Y12).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florence
• Collaborator: Tuscany Region
• Treatments: Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

• Unstable or NSTEMI

Exclusion Criteria:

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