The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin... | NCT00133731

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

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Oct 2005Actual

First Submitted Date

Aug 23, 2005

First Submission Date that Met QC Criteria

Aug 23, 2005

First Posted Date

Aug 24, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2008

Last Update Posted Date

Jul 2, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

947Actual

Measure	Description	Time Frame
Death, myocardial infarction, and urgent and non-urgent target vessel revascularization

Measure	Description	Time Frame
Bleeding events

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Los Angeles Cardiology Associates		Los Angeles	California	90017	United States
Anil V. Shah, MD

Label	URL
Related Info	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019060	Minimally Invasive Surgical Procedures

Name	Type	Description	Arm Group Labels	Other Names
Otamixaban (XRP0673)	Drug
Unfractionated Heparin	Drug
Percutaneous Coronary Intervention	Procedure

ID	Term
C435830	otamixaban
D006493	Heparin
D062645	Percutaneous Coronary Intervention