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Eptifibatide

Phase 3

Myocardial Ischemia | Small molecule | Cardiovascular |Organon & Co.|Last Updated: May 17, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment9,406
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00089895EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)PHASE3 COMPLETED 9,406Nov 1, 2004Nov 1, 2008May 17, 2024 -
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Study Endpoints
Primary Endpoints
Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.
96 hours after randomization
Secondary Endpoints
Incidence of the Composite of Death/MI.
30 days after randomization
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EptifibatideEXPERIMENTALEptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.
PlaceboPLACEBO_COMPARATORPlacebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.
Interventions
NameTypeDescription
Eptifibatide (Integrilin)DRUGintravenous; 180 mcg/kg bolus followed by infusion of 2 mcg/kg/min for 12 to 96 hours (or longer if necessary to complete the 18- to 24-hour post-PCI infusion period, or up to 120 hours in patients who proceed to CABG \[coronary artery bypass graft\]); second bolus of 180 mcg/kg administered 10 minutes after first bolus.
PlaceboDRUGintravenous; delivery to match eptifibatide to maintain blind
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Willing and able to give informed consent and comply with study procedures and follow-up through 1 year. * Plan to undergo an invasive strategy after receiving study drug for 12 to 96 hours. * Able to be randomized into the trial within 12 hours of having symptoms of acute cor...

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