Status:
COMPLETED
Novel Approaches in Preventing and Limiting Events III Trial (NAPLES III): Bivalirudin in High-risk Bleeding Patients
Lead Sponsor:
Clinica Mediterranea
Conditions:
Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Bleeding occurring during percutaneous coronary interventions (PCI has now emerged as one of the most common complication of PCI and adversely affect in-hospital, short- and long-term outcome.As bival...
Detailed Description
Antithrombotic and antiplatelet therapies have been the focus of extensive clinical investigations over the past 2 decades. In PCI settings all therapies inhibiting coagulation and primary hemostasis ...
Eligibility Criteria
Inclusion
- • Male or female able to understand and sign a witnessed informed consent
- Age ≥ 18 ys
- Patients with stable (CCS 1-4) or unstable angina pectoris (but with the most recent anginal episode occurring \>48 hours before the procedure) or documented silent ischemia
- Stable Hemodynamic conditions (systolic BP \> 100 HR \> 40 \< 100).
- No clinical and ECG changes suggestive of ongoing acute or recent (\<48 hours) myocardial infarction.
- Bleeding risk score ≥ 10
- Procedure planned via femoral approach
- Double antiplatelet therapy.
- 2.2 Angiographic inclusion criteria
- • Angiographic evidence of a de novo lesion \> 50% requiring intervention
Exclusion
- • Female sex with childbearing potential
- Age \<18 years
- Ongoing or recent episode (\<48 hours) of unstable coronary artery disease (including both ST-elevation and non-ST-elevation acute coronary syndromes)
- Chronic kidney disease (estimated glomerular filtration rate \<30mL/min/1.73 m2).
- Ongoing serious bleeding or bleeding diathesis
- Previous stroke in the last 6 months
- Platelet count ≤100,00 per mm3
- History of heparin- induced-thrombocytopenia
- Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or sensitivity to contrast which cannot be adequately pre-medicated.
- Hemodynamic instability (systolic blood pressure \< 100 mm Hg; heart rate \< 40 bpm or \>100 bpm; complex ventricular arrhythmias; AV block) requiring balloon counterpulsation or inotropic support.
- The patient is simultaneously participating in another device or drug study. Patient must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this study.
- Positive clinical history for intracranial neoplasia, AV malformation, aneurysm.
- INR ≥ 2.0 or prothrombin time 1.2 times upper limit of normality
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
837 Patients enrolled
Trial Details
Trial ID
NCT01465503
Start Date
January 1 2008
End Date
December 1 2013
Last Update
April 8 2014
Active Locations (2)
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1
IRCCS Policlinico Multimedica
Milan, Milan, Italy, 20142
2
Clinica Mediterranea
Naples, Naples, Italy, 80121