Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention

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

Outcome

Outcome not reported

Stopped: “DSMB halted the study early due to futility. There were no safety concerns.”

Drugs

Indications