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The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00133731
  Purpose

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 Intervention Phase
Angioplasty, Transluminal, Percutaneous Coronary
 Drug: Otamixaban (XRP0673)
Drug: Unfractionated Heparin
Procedure: Percutaneous Coronary Intervention
 Phase II

MedlinePlus related topics: Blood Thinners
Drug Information available for: Heparin Antithrombin III Otamixaban
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety Study
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

Further study details as provided by Sanofi-Aventis:

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

Secondary Outcome Measures:
  • Bleeding events

Enrollment: 947
Study Start Date: September 2004
Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133731

  Show 89 Study Locations
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: ICD CSD Sanofi-Aventis
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: sanofi-aventis ( ICD Study Director )
Study ID Numbers: DRI6199, XRP0673
Study First Received: August 23, 2005
Last Updated: July 1, 2008
ClinicalTrials.gov Identifier: NCT00133731  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Heparin, Low-Molecular-Weight
Antithrombin III
Heparin
Calcium heparin

Additional relevant MeSH terms:
Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
 Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009



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