Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention — STATUS PCI  

Coronary Artery Disease Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT01464671
• Study type: Interventional
• Source: Stony Brook University
• Status: Terminated
• Phase: Phase 4
• Start date: July 2009
• Completion date: September 2014