drugset / Trial / NCT01464671

Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention

NCT01464671

Phase 4 Terminated 260 enrolled Stony Brook University
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin) versus unfractionated heparin (UFH) in patients presenting with stable angina or silent ischemia (positive stress test without chest pain) that undergo percutaneous coronary intervention (PCI). The primary endpoint of the study will be major and minor bleeding events, defined by the REPLACE-2 trial definition, during the index hospitalization and up to 30 days post discharge.

Timeline

Start
2009-07
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bivalirudin Peptide
Comparator Heparin Other / unclassified