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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00133731
First received: August 23, 2005
Last updated: July 1, 2008
Last verified: June 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
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
  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
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: NCT00133731

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

Additional Information:
No publications provided

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

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

ClinicalTrials.gov processed this record on October 23, 2014