NCT01464671

Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention

STATUS-PCI: Stable Angina Therapy With Angiomax® or Unfractionated Heparin for patientS Undergoing Percutaneous Coronary Intervention

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to compare in a randomized, controlled, single-blinded, 1:1 fashion UFH versus bivalirudin in patients with stable angina pectoris or silent ischemia undergoing PCI. Secondary study endpoints will include: * Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral vascular accident (CVA). * Net adverse clinical events (NACE) will be consistent of MACE plus major bleeding as defined by the REPLCE-2 criteria. * Cardiac death in-hospital and up to 30 days post discharge. * MI in-hospital and up to 30 days post discharge. * CVA in-hospital and up to 30 days post discharge. * Incidence of all-cause mortality at 6 months and 1 year. * MACE at 6 months and 1 year. * Incidence of acute (0-24 hours post procedure) stent thrombosis rates. * Incidence of sub-acute (24 hours - 30 days) stent thrombosis rates. * Length of hospital stay (LOS) * Economic analysis (total cost during hospitalization) and up to 30 days post discharge.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Bivalirudin	Anticoagulation during percutaneous coronary intervention
DRUG	Heparin	Anticoagulation during percutaneous coronary intervention

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2011-11-03
• Last updated: 2014-11-20

Locations

1 site across 1 country: United States