NCT00317395|CompletedPhase 2DMC

Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome

SEPIA-ACS1

A Randomized, Double-blind, Triple-dummy, Dose-ranging Study, Including an Active Control of Unfractionated Heparin and Eptifibatide, to Evaluate the Clinical Efficacy and Safety of Otamixaban, in Patients With Non-ST Elevation Acute Coronary Syndrome and Planned Early Invasive Strategy

Sanofi ClinicalTrials.gov

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3 other identifiers

DRI6624XRP0673A/20032006-000506-22

Study Type

interventional

Target

3,241

Locations

35 countries

Sites

Timeline

RegisteredApr 2006

StartedJun 2006

CompletionMar 2009

Brief Summary

Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous \[IV\] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy. Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and pharmacodynamics (PD).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

3,241

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jun 2006

Geographic Reach

35 countries

35 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

First Submitted

Initial submission to the registry

April 21, 2006

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2006

Completed

1 month until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed

Last Updated

December 3, 2014

Status Verified

November 1, 2014

Enrollment Period

2.3 years

First QC Date

April 21, 2006

Last Update Submit

November 17, 2014

Conditions

Coronary Disease

Keywords

Non ST elevation Acute Coronary SyndromeEarly invasive strategyPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor
within 7 days following randomization

Secondary Outcomes (4)

Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleeding
within 7 days and 30 days following randomization
Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor
within 30 days, 90 days and 180 days following randomization
Incidence of TIMI significant bleeding
within 7 days following randomization
Incidence of all bleedings
within 7 days and 30 days following randomization

Study Arms (6)

Otamixaban Dose 1

EXPERIMENTAL

dosage regimen 1

Drug: Otamixaban (XRP0673)

Otamixaban Dose 2

EXPERIMENTAL

dosage regimen 2

Drug: Otamixaban (XRP0673)

Otamixaban Dose 3

EXPERIMENTAL

dosage regimen 3

Drug: Otamixaban (XRP0673)

Otamixaban Dose 4

EXPERIMENTAL

dosage regimen 4

Drug: Otamixaban (XRP0673)

Otamixaban Dose 5

EXPERIMENTAL

dosage regimen 5

Drug: Otamixaban (XRP0673)

UFH/Eptifibatide

ACTIVE COMPARATOR

Drug: unfractionated heparinDrug: eptifibatide

Interventions

Otamixaban (XRP0673)DRUG

intravenous administration

Otamixaban Dose 1Otamixaban Dose 2Otamixaban Dose 3Otamixaban Dose 4Otamixaban Dose 5

unfractionated heparinDRUG

intravenous administration

UFH/Eptifibatide

eptifibatideDRUG

intravenous administration

UFH/Eptifibatide

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ischemic discomfort at rest ≥ 10 minutes within 24 hours of randomization
Electrocardiogram (ECG) criteria for non-ST elevation ACS or cardiac enzyme elevation (\> upper limit of normal \[ULN\])
No ST elevation Myocardial Infarction (STEMI)
Planned coronary angiography followed when indicated by a Percutaneous Coronary Intervention (PCI) on Day 1 to Day 3

You may not qualify if:

Inability to undergo coronary angiography or PCI by Day 3
Prior PCI within 30 days
Acute STEMI
Cardiogenic shock
Anticoagulant treatment for \> 24 hours prior to randomization
Prior treatment with fondaparinux since ACS onset
Requirement for oral anticoagulant (OAC) prior to Day 30
Creatinine clearance \< 30 ml/min

Contact the study team to confirm eligibility.