NCT00317395·Phase 2·INTERVENTIONAL

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

Eptifibatide Other Completed

Status

Completed

Phase

Phase 2

Enrollment

3,241

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

DRUG

Otamixaban (XRP0673)

intravenous administration

DRUG

unfractionated heparin

intravenous administration

DRUG

eptifibatide

intravenous administration

Timeline

From registration to results.

First posted
Apr 24, 2006
Study start
Jun 2006
Primary completion
Oct 2008
Study completion
Mar 2009
Results posted
Not reported
Registry updated
Dec 3, 2014

Outcomes

What the study measures.

Primary outcomes

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

Time frame · within 7 days following randomization

Secondary outcomes

Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleeding

Time frame · within 7 days and 30 days following randomization

Time frame · within 30 days, 90 days and 180 days following randomization

Incidence of TIMI significant bleeding

Time frame · within 7 days following randomization

Incidence of all bleedings

Time frame · within 7 days and 30 days following randomization

Eligibility

Who can take part.

Minimum age: 18 Years
Maximum age: Not reported
Sex: ALL
Healthy volunteers: No

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

Study locations

36 registered sites.

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) · United States. Showing up to 24 locations stored in the fast local snapshot.