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

NCT ID: NCT00317395

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

3241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Otamixaban Dose 1

dosage regimen 1

Group Type EXPERIMENTAL

Otamixaban (XRP0673)

Intervention Type DRUG

intravenous administration

Otamixaban Dose 2

dosage regimen 2

Group Type EXPERIMENTAL

Otamixaban (XRP0673)

Intervention Type DRUG

intravenous administration

Otamixaban Dose 3

dosage regimen 3

Group Type EXPERIMENTAL

Otamixaban (XRP0673)

Intervention Type DRUG

intravenous administration

Otamixaban Dose 4

dosage regimen 4

Group Type EXPERIMENTAL

Otamixaban (XRP0673)

Intervention Type DRUG

intravenous administration

Otamixaban Dose 5

dosage regimen 5

Group Type EXPERIMENTAL

Otamixaban (XRP0673)

Intervention Type DRUG

intravenous administration

UFH/Eptifibatide

Group Type ACTIVE_COMPARATOR

unfractionated heparin

Intervention Type DRUG

intravenous administration

eptifibatide

Intervention Type DRUG

intravenous administration

Interventions

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Otamixaban (XRP0673)

intravenous administration

Intervention Type DRUG

unfractionated heparin

intravenous administration

Intervention Type DRUG

eptifibatide

intravenous administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis Administrative Office

Buenos Aires, , Argentina

Site Status

Sanofi-Aventis Administrative Office

Vienna, , Austria

Site Status

Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Site Status

Sanofi-Aventis Administrative Office

Sofia, , Bulgaria

Site Status

Sanofi-Aventis Administrative Office

Laval, Quebec, Canada

Site Status

Sanofi-Aventis Administrative Office

Santiago, , Chile

Site Status

Sanofi-Aventis Administrative Office

Cali, , Colombia

Site Status

Sanofi-Aventis Administrative Office

Zagreb, , Croatia

Site Status

Sanofi-Aventis Administrative Office

Prague, , Czechia

Site Status

Sanofi-Aventis Administrative Office

Hørsholm, , Denmark

Site Status

Sanofi-Aventis Administrative Office

Tatari, , Estonia

Site Status

Sanofi-Aventis Administrative Office

Helsinki, , Finland

Site Status

Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Sanofi-Aventis Administrative Office

Berlin, , Germany

Site Status

Sanofi-Aventis Administrative Office

Athens, , Greece

Site Status

Sanofi-Aventis Administrative Office

Budapest, , Hungary

Site Status

Sanofi-Aventis Administrative Office

Mumbai, , India

Site Status

Sanofi-Aventis Administrative Office

Netanya, , Israel

Site Status

Sanofi-Aventis Administrative Office

Milan, , Italy

Site Status

Sanofi-Aventis Administrative Office

Kuala Lumpur, , Malaysia

Site Status

Sanofi-Aventis Administrative Office

México, , Mexico

Site Status

Sanofi-Aventis Administrative Office

Gouda, , Netherlands

Site Status

Sanofi-Aventis Administrative Office

Warsaw, , Poland

Site Status

Sanofi-Aventis Administrative Office

Porto Salvo, , Portugal

Site Status

Sanofi-Aventis Administrative Office

Bucharest, , Romania

Site Status

Sanofi-Aventis Administrative Office

Moscow, , Russia

Site Status

Sanofi-Aventis Administrative Office

Singapore, , Singapore

Site Status

Sanofi-Aventis Administrative Office

Bratislava, , Slovakia

Site Status

Sanofi-Aventis Administrative Office

Midrand, , South Africa

Site Status

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Site Status

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Site Status

Sanofi-Aventis Administrative Office

Geneva, , Switzerland

Site Status

Sanofi-Aventis Administrative Office

Taipei, , Taiwan

Site Status

Sanofi-Aventis Administrative Office

Bangkok, , Thailand

Site Status

Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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United States Argentina Austria Brazil Bulgaria Canada Chile Colombia Croatia Czechia Denmark Estonia Finland France Germany Greece Hungary India Israel Italy Malaysia Mexico Netherlands Poland Portugal Romania Russia Singapore Slovakia South Africa South Korea Spain Switzerland Taiwan Thailand Turkey (Türkiye)

References

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Sabatine MS, Antman EM, Widimsky P, Ebrahim IO, Kiss RG, Saaiman A, Polasek R, Contant CF, McCabe CH, Braunwald E. Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2009 Sep 5;374(9692):787-95. doi: 10.1016/S0140-6736(09)61454-9. Epub 2009 Aug 28.

Reference Type RESULT
PMID: 19717184 (View on PubMed)

Other Identifiers

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XRP0673A/2003

Identifier Type: OTHER

Identifier Source: secondary_id

2006-000506-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DRI6624

Identifier Type: -

Identifier Source: org_study_id