Clinical Trials

Eptifibatide Acetate has been evaluated in numerous clinical trials investigating its efficacy across various cardiovascular and cerebrovascular disorders, including myocardial infarction, acute coronary syndrome, coronary artery disease, and acute ischemic stroke, as well as severe pneumonia. These investigations span Phase 1 through Phase 4 clinical studies sponsored by academic institutions, research foundations, and government organizations, such as the Ottawa Heart Institute Research Corporation, the University of Alabama at Birmingham, and the Ministry of Science and Technology of the People's Republic of China. Several trials, including NCT00251823 assessing eptifibatide-facilitated percutaneous coronary intervention and NCT02925923 examining antiplatelet strategies in troponin-negative acute coronary syndrome, have reached completed status. Additional studies maintain terminated or unknown recruitment statuses while exploring adjunctive intracoronary and endovascular interventions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07347626 NOT_YET_RECRUITING
Acute Ischemic Stroke
Xinqiao Hospital of Chongqing
2026-03-01 PHASE3
NCT03735979 COMPLETED
Acute Ischemic Stroke
Washington University School of Medicine
2019-10-15 PHASE3
NCT03844594 UNKNOWN
Acute Ischemic Stroke
Ministry of Science and Technology of the People´s Republic of China
2019-04-06 PHASE3
NCT01522417 COMPLETED
Myocardial Infarction; Acute Coronary Syndromes; Unstable Angina
Medicure
2012-04 PHASE2
NCT02925923 COMPLETED
Acute Coronary Syndrome; Angina, Unstable
University of Alabama at Birmingham
2016-11-01 PHASE2
NCT02204852 COMPLETED
Septic Shock
Sisse R. Ostrowski, MD PhD DMSc
2014-09 PHASE2
NCT01919723 COMPLETED
Acute Coronary Syndrome
University of Alabama at Birmingham
2014-02 PHASE2
NCT01977456 COMPLETED
Stroke; Brain Infarction
Arthur Pancioli
2013-09 PHASE2
NCT01532544 TERMINATED
Pneumonia
Thrombologic ApS
2012-06 PHASE2
NCT01076764 COMPLETED
Acute Coronary Syndrome
Sanofi
2010-04 PHASE3
NCT00894803 COMPLETED
Ischemic Stroke; Stroke; Brain Infarction
University of Cincinnati
2009-07 PHASE2
NCT00834899 TERMINATED
Sickle Cell Disease
University of North Carolina, Chapel Hill
2009-01 PHASE1; PHASE2
NCT01863134 COMPLETED
Non ST Elevation Myocardial Infarction
Medical University of Silesia
2005-01 PHASE4
NCT00812435 TERMINATED
Myocardial Infarction
Medstar Health Research Institute
2007-08 PHASE3
NCT00638976 COMPLETED
Cardiovascular Disease
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
2007-11 PHASE3
NCT00945308 UNKNOWN
Acute Myocardial Infarction
Assaf-Harofeh Medical Center
2009-08 PHASE2
NCT00061373 COMPLETED
Ischemic Stroke
National Institute of Neurological Disorders and Stroke (NINDS)
2003-05 PHASE2
NCT01454440 TERMINATED
Coronary Artery Disease
University of Turin, Italy
2007-10 PHASE4
NCT00089895 COMPLETED
Myocardial Ischemia; Acute Coronary Syndrome
Organon and Co
2004-11-01 PHASE3
NCT00719914 TERMINATED
ST-Elevation Myocardial Infarction
Brigham and Women's Hospital
2007-11 PHASE2
NCT00317395 COMPLETED
Coronary Disease
Sanofi
2006-06 PHASE2
NCT00426751 COMPLETED
Infarction, Myocardial
GlaxoSmithKline
2006-10 PHASE3
NCT00111566 COMPLETED
Coronary Artery Disease; Myocardial Infarction
Cardiology Research UBC
2004-12 PHASE4
NCT00251823 COMPLETED
Myocardial Infarction
Ottawa Heart Institute Research Corporation
2005-07 PHASE3
NCT00370045 UNKNOWN
Coronary Artery Disease
LifeBridge Health
2006-03 PHASE4
NCT00289601 TERMINATED
Angioplasty
Brigham and Women's Hospital
2006-03 PHASE4
NCT00250991 COMPLETED
Stroke
University of Cincinnati
2003-07 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-01-16)

Check the Eptifibatide Acetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Eptifibatide Acetate selectively binds to the platelet membrane glycoprotein IIb/IIIa receptor, reversibly inhibiting the binding of fibrinogen and von Willebrand factor to block inter-platelet cross-linking. This targeted inhibition prevents platelet aggregation and thrombus formation, thereby reducing ischemic complications in clinical settings such as acute coronary syndrome, myocardial infarction, and ischemic stroke.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.