NCT00464087

Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI

Switching From Arixtra (Fondaparinux) to Angiomax (Bivalirudin) or Unfractionated Heparin in Patients With Acute Coronary Syndromes (ACS) Without ST-segment Elevation Undergoing Percutaneous Coronary Intervention (PCI): SWITCH III

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this clinical trial is to evaluate safety of switching from fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute coronary syndrome undergoing percutaneous coronary angioplasty.

Detailed description

This is a prospective open label, randomized, multi-center registry. One hundred patients who received fondaparinux within the 24 hours prior to presentation to the coronary catheterization lab and who are suitable for percutaneous coronary intervention. The patients will be randomized in a 1:1 fashion to either unfractionated heparin or bivalirudin during the angioplasty. All patients will be followed throughout the duration of the hospital stay.

Conditions

• Acute Coronary Syndromes

Interventions

Type	Name	Description
DRUG	Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2007-04-20
• Last updated: 2013-08-01
• Results posted: 2013-08-01

Locations

7 sites across 2 countries: United States, Canada