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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: August 23, 2005
Last updated: July 1, 2008
Last verified: June 2008
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Sanofi:

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

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

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
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 identifier: NCT00133731

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

Additional Information:
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00133731     History of Changes
Other Study ID Numbers: DRI6199
Study First Received: August 23, 2005
Last Updated: July 1, 2008

Additional relevant MeSH terms:
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors processed this record on June 23, 2017