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The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention (SEPIA-PCI)

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ClinicalTrials.gov Identifier: NCT00133731
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : July 2, 2008
Sponsor:
Information provided by:
Sanofi

Brief Summary:
The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.

Condition or disease Intervention/treatment Phase
Angioplasty, Transluminal, Percutaneous Coronary Drug: Otamixaban (XRP0673) Drug: Unfractionated Heparin Procedure: Percutaneous Coronary Intervention Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 947 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multinational, Randomized, Double-Blind, Double-Dummy, Exploratory, Parallel Group, Dose-Ranging Phase II Study to Evaluate Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Several Intravenous Regimens of Factor Xa Inhibitor Otamixaban (XRP0673), in Comparison to Intravenous Unfractionated Heparin, in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
Study Start Date : September 2004
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources




Primary Outcome Measures :
  1. Death, myocardial infarction, and urgent and non-urgent target vessel revascularization

Secondary Outcome Measures :
  1. Bleeding events


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Due to undergo non-urgent percutaneous coronary intervention (PCI)
  • Planned treatment with aspirin and clopidogrel

Exclusion Criteria:

  • Recent acute coronary syndrome
  • Patients at risk for, or with prior recent, bleeding
  • Patients have received recent prior treatment with an anticoagulant
  • Creatinine clearance > 30 ml/min

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133731


  Show 89 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi

Additional Information:
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00133731     History of Changes
Other Study ID Numbers: DRI6199
XRP0673
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: July 2, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Calcium heparin
Otamixaban
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors