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

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

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00133731

Acronym

SEPIA-PCI

Enrollment

947

Registered

2005-08-24

Start date

2004-09-30

Completion date

2005-10-31

Last updated

2008-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioplasty, Transluminal, Percutaneous Coronary

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.

Interventions

DRUGOtamixaban (XRP0673)

DRUGUnfractionated Heparin

PROCEDUREPercutaneous Coronary Intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Death, myocardial infarction, and urgent and non-urgent target vessel revascularization	—

Secondary

Measure	Time frame
Bleeding events	—

Countries

Belgium, Canada, Czechia, France, Germany, Netherlands, Slovakia, South Africa, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026