NCT00133731

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

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00133731

Principal Investigator:

Study Type:

INTERVENTIONAL

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Angioplasty, Transluminal, Percutaneous Coronary

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Otamixaban (XRP0673)
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: Unfractionated Heparin
- Description:
- Arm Group Labels:
- Type: PROCEDURE
- Name: Percutaneous Coronary Intervention
- Description:
- Arm Group Labels:

Sponsor

Sanofi