CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Switching from Fondaparinux to Bivalirudin or Unfractionated Heparindrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age >18 years, male or female
  • ✓Acute coronary syndrome with unstable angina or NSTEMI, evidenced by either elevated troponin/CK-MB or ischemic ECG changes
  • ✓Scheduled for coronary angiography with possible angioplasty
  • ✓Able and willing to provide informed consent and comply with study requirements
Key exclusion· 14
  • ✕ST-elevation MI within preceding 48 hours
  • ✕Body weight <110 lbs (50 kg) or >400 lbs (181.2 kg)
  • ✕Recent anticoagulant use: bivalirudin, GP IIb/IIIa inhibitors, or low-molecular weight heparin within 24 hours; or unfractionated heparin ≤90 minutes before fondaparinux
  • ✕Active bleeding or bleeding diathesis in preceding 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00464087
NCT00464087Phase 3Completed
CompareCT.gov

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

Medstar Health Research Institute·interventional·Posted Apr 20, 2007·Updated Aug 1, 2013

In Brief

A Phase 3 clinical trial evaluating Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin for Acute Coronary Syndromes. Completed, enrolled 100 participants across 7 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndromes
CountriesCanada, United States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 20, 2007
Enrollment StartJun 1, 2007
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 19.2 years ago

Interventions

Switching from Fondaparinux to Bivalirudin or Unfractionated Heparindrug