Recent Updates
Recently added Catalysts

Eptifibatide

Phase 3

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment9,406

FDA Designations

No designations recorded

Clinical trial landscape

Eptifibatide · 1 trial · 2 indications

Phase 3 1
NCT00089895EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)Myocardial Ischemia
COMPLETED9,406 Analytics
PHASE3COMPLETED
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
Myocardial IschemiaUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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...

Unlock Eligibility Criteria

Frequently asked questions about Eptifibatide

What is Eptifibatide used for in Myocardial Ischemia?

Eptifibatide is a small molecule being studied for the treatment of Myocardial Ischemia, specifically in patients with non-ST-segment elevation acute coronary syndrome. It is currently in Phase 3 clinical development and is not yet approved for this indication.

What does Eptifibatide target?

Eptifibatide targets the glycoprotein IIb/IIIa receptor on platelets. By inhibiting this receptor, it prevents platelet aggregation, which is a key step in the formation of blood clots that can lead to myocardial ischemia and acute coronary syndromes.

Who makes Eptifibatide?

Eptifibatide is being developed by Organon & Co., a company listed on the New York Stock Exchange under the ticker symbol OGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with myocardial ischemia.

What phase is Eptifibatide in?

Eptifibatide is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the treatment of myocardial ischemia. The Phase 3 trial has been completed, and the results will determine its future development.

What clinical trials is Eptifibatide in?

Eptifibatide has one completed Phase 3 clinical trial registered as NCT00089895, known as the EARLY ACS study. This trial enrolled 9,406 patients with non-ST-segment elevation acute coronary syndrome and was a randomized, double-blind, placebo-controlled study.

Is Eptifibatide the same as Integrilin?

Eptifibatide is also known by the brand name Integrilin. It is a glycoprotein IIb/IIIa inhibitor used to prevent platelet aggregation in patients with acute coronary syndromes, including those undergoing percutaneous coronary intervention.