Enoxaparin Versus Unfractionated Heparin in PCI

This study has been completed.
Sponsor:
Information provided by:
Triemli Hospital
ClinicalTrials.gov Identifier:
NCT00439855
First received: February 23, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

Enoxaparin 0.75mg/kg BW is not inferior to weight adjusted unfractionated heparin as anticoagulation for PCI


Condition Intervention Phase
Coronary Artery Disease
Drug: Enoxaparin i.v.
Drug: unfractionated heparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enoxaparin Versus Unfractionated Heparin in PCI

Resource links provided by NLM:


Further study details as provided by Triemli Hospital:

Primary Outcome Measures:
  • Quadruple endpoint: death, MI, urgent TVR, major bleeding

Secondary Outcome Measures:
  • major bleeding, minor bleeding, thrombocytopenia

Estimated Enrollment: 2100
Study Start Date: September 2003
Estimated Study Completion Date: February 2006
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PCI for stable ischemia or ACS

Exclusion Criteria:

  • Cardiogenic shock,
  • Pretreatment with study drugs,
  • Lack of informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439855

Locations
Switzerland
Division of Cardiology Triemli Hospital Zurich
Zurich, Switzerland, 8063
Sponsors and Collaborators
Triemli Hospital
Investigators
Principal Investigator: osmund bertel, MD Division of Cardiology Triemli Hospital Zurich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00439855     History of Changes
Other Study ID Numbers: ZEUS
Study First Received: February 23, 2007
Last Updated: February 23, 2007
Health Authority: Switzerland: Ethikkommission

Keywords provided by Triemli Hospital:
Enoxaparin, heparin, hemorrhages

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium heparin
Heparin
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014