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)
Mechanism and Biochemical Profile
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>).
- Eptifibatide Acetate Solubility in DMSO
- Eptifibatide Acetate Stock Solution
- Eptifibatide Acetate Storage
- Eptifibatide Acetate Stability
- Eptifibatide Acetate Molecular Weight
- Eptifibatide Acetate SMILES
- Eptifibatide Acetate CAS Number
- Eptifibatide Acetate Chemical Structure (2D and 3D)
- Eptifibatide Acetate SDS|MSDS