Novel Approaches in Preventing and Limiting Events III Trial (NAPLES III): Bivalirudin in High-risk Bleeding Patients

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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 bivalirudin proved its effectiveness in decreasing haemorrhagic events during PCI, its administration may be advocated in subjects deemed at high risk of bleeding.Objective of the present trial is to compare the safety and effectiveness of procedural use of bivalirudin in comparison to unfractionated heparin (UFH) in patients undergoing PCI deemed at high risk of procedural bleeding.

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

Details

• Lead Sponsor: Clinica Mediterranea
• Treatments: Bivalirudin; Calcium heparin; Heparin; Hirudins

Criteria

Inclusion Criteria:

• • 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.

4.2.2 Angiographic inclusion criteria

• Angiographic evidence of a de novo lesion > 50% requiring intervention

Exclusion Criteria:

• • 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