Back to resultsEnoxaparin Versus Unfractionated Heparin in PCI
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Enoxaparin i.v.
unfractionated heparin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Enoxaparin, heparin, hemorrhages
Eligibility Criteria
Inclusion Criteria:
- PCI for stable ischemia or ACS
Exclusion Criteria:
- Cardiogenic shock,
- Pretreatment with study drugs,
- Lack of informed consent
Sites / Locations
- Division of Cardiology Triemli Hospital Zurich
Outcomes
Primary Outcome Measures
Quadruple endpoint: death, MI, urgent TVR, major bleeding
Secondary Outcome Measures
major bleeding, minor bleeding, thrombocytopenia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00439855
Brief Title
Enoxaparin Versus Unfractionated Heparin in PCI
Official Title
Enoxaparin Versus Unfractionated Heparin in PCI
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Triemli Hospital
4. Oversight
5. Study Description
Brief Summary
Enoxaparin 0.75mg/kg BW is not inferior to weight adjusted unfractionated heparin as anticoagulation for PCI
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Enoxaparin, heparin, hemorrhages
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Enoxaparin i.v.
Intervention Type
Drug
Intervention Name(s)
unfractionated heparin
Primary Outcome Measure Information:
Title
Quadruple endpoint: death, MI, urgent TVR, major bleeding
Secondary Outcome Measure Information:
Title
major bleeding, minor bleeding, thrombocytopenia
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PCI for stable ischemia or ACS
Exclusion Criteria:
Cardiogenic shock,
Pretreatment with study drugs,
Lack of informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
osmund bertel, MD
Organizational Affiliation
Division of Cardiology Triemli Hospital Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology Triemli Hospital Zurich
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland
12. IPD Sharing Statement
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Enoxaparin Versus Unfractionated Heparin in PCI
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