Clinical Trials

Tirofiban Hydrochloride has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 to assess its therapeutic utility in acute coronary syndrome, acute myocardial infarction, coronary artery disease, acute ischemic stroke, transient ischemic attack, and thromboembolic events associated with endovascular procedures. Sponsored predominantly by academic medical centers, university hospitals, and clinical research collaboratives, these studies encompass various recruitment statuses, including actively recruiting, completed, terminated, and enrolling by invitation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07379190 RECRUITING
Stroke, Acute; Stroke, Ischemic; Cerebral Infarction
Weifang Medical University
 2026-06-22 PHASE3
NCT07493577 NOT_YET_RECRUITING
Aneurysmal Subarachnoid Hemorrhage
Dr David Hasan, M.D.
 2026-07-23 PHASE1; PHASE2
NCT07760922 NOT_YET_RECRUITING
Ischemic Stroke, Acute
Xinqiao Hospital of Chongqing
 2026-10-01 PHASE4
NCT07111806 NOT_YET_RECRUITING
Acute Ischemic Stroke
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2025-12-01 PHASE3
NCT07537933 NOT_YET_RECRUITING
Acute Ischemic Stroke; Large-vessel Occlusion; Endovascular Treatment
Shandong Provincial Hospital
 2026-04 PHASE3
NCT06769256 RECRUITING
ST-segment Elevation Myocardial Infarction (STEMI)
Henan Institute of Cardiovascular Epidemiology
 2025-01-01 PHASE4
NCT07135089 RECRUITING
Stroke, Ischemic
General Hospital of Shenyang Military Region
 2025-11-13 PHASE3
NCT07026318 RECRUITING
Acute Ischemic Stroke
Beijing Anzhen Hospital
 2025-08-15
NCT07095790 RECRUITING
Mild Stroke
Second Affiliated Hospital of Soochow University
 2025-08-30 PHASE4
NCT07335107 NOT_YET_RECRUITING
Acute Ischemic Stroke
Beijing Tiantan Hospital
 2026-01-12 PHASE3
NCT07290751 RECRUITING
Acute Ischemic Stroke
Beijing Anzhen Hospital
 2025-11-11 PHASE4
NCT06373042 NOT_YET_RECRUITING
Stroke, Acute Ischemic
Zhongming Qiu
 2024-07-31 PHASE2; PHASE3
NCT06587347 UNKNOWN
Acute Stroke; Ischemic Stroke, Acute; Cerebral Infarction
Capital Medical University
 2024-11-20 PHASE2; PHASE3
NCT05225961 COMPLETED
Acute Ischemic Stroke
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2026-03-20 PHASE4
NCT05728333 RECRUITING
Stroke, Acute Ischemic
Xinqiao Hospital of Chongqing
 2023-11-28 PHASE2; PHASE3
NCT06037889 COMPLETED
Branch Atheromatous Disease
Peking Union Medical College Hospital
 2023-11-09 PHASE3
NCT06045156 RECRUITING
Acute Ischemic Stroke
The First Hospital of Jilin University
 2024-04-29
NCT05604638 RECRUITING
Acute Ischemic Stroke
Second Affiliated Hospital of Guangxi Medical University
 2024-04-24 PHASE3
NCT06265051 COMPLETED
Acute Ischemic Stroke; Vessel Occlusion
Xiang Luo
 2024-04-09 PHASE2; PHASE3
NCT06238115 COMPLETED
Unruptured Intracranial Aneurysm; Flow Diverter; Stent-assisted Coiling; Thromboembolic Events
Beijing Tiantan Hospital
 2024-03-04 PHASE2; PHASE3
NCT06966674 RECRUITING
No-Reflow; STEMI; Intracoronary; Tirofiban
Kafrelsheikh University
 2025-05-12
NCT06319846 RECRUITING
Ischemic Stroke, Acute; TIA; Symptomatic Intracranial Artery Stenosis
Beijing Tiantan Hospital
 2024-07-11 PHASE3
NCT05310968 COMPLETED
Branch Atheromatous Disease
Beijing Tiantan Hospital
 2022-11-12 PHASE4
NCT04818944 WITHDRAWN
Acute Ischemic Stroke; Ischemic Stroke
University of Iowa
 2023-03-01 PHASE1; PHASE2
NCT06134622 COMPLETED
Acute Ischemic Stroke
The First Affiliated Hospital of University of Science and Technology of China
 2024-03-14 PHASE3
NCT05841147 UNKNOWN
Intracranial Aneurysm
Lu Hua
 2023-04-25 PHASE4
NCT04851457 COMPLETED
Ischemic Stroke
Shanghai East Hospital
 2021-04-06 PHASE2
NCT05188417 UNKNOWN
Acute Ischemic Stroke
GrandPharma (China) Co., Ltd.
 2021-12-09 PHASE2
NCT04491695 UNKNOWN
Acute Stroke
Capital Medical University
 2020-09-12 PHASE2; PHASE3
NCT04111289 UNKNOWN
High Bolus Dose of Tirofiban
Assiut University
 2019-11-01 PHASE1; PHASE2
NCT03797729 UNKNOWN
ST Elevation Myocardial Infarction
Shanghai Zhongshan Hospital
 2019-05-14 PHASE4
NCT03691727 COMPLETED
Subarachnoid Hemorrhage, Aneurysmal
David Hasan
 2019-01-24 PHASE1; PHASE2
NCT03357133 TERMINATED
Ischemic Stroke
Capital Medical University
 2017-12-16 PHASE2; PHASE3
NCT04368377 COMPLETED
Pneumonia, Viral; Corona Virus Infection; Respiratory Failure; Embolism and Thrombosis
University of Milan
 2020-04-06 PHASE2
NCT02978040 COMPLETED
Coronary Artery Disease; STEMI - ST Elevation Myocardial Infarction
Insel Gruppe AG, University Hospital Bern
 2017-07-04 PHASE4
NCT03406832 UNKNOWN
ST Segment Elevation Myocardial Infarction; Elective Percutaneous Coronary Intervention
The First Affiliated Hospital of Zhengzhou University
 2018-01-08
NCT03406819 UNKNOWN
ST Segment Elevation Myocardial Infarction; Primary Percutaneous Coronary Intervention
The First Affiliated Hospital of Zhengzhou University
 2018-01-07
NCT01522417 COMPLETED
Myocardial Infarction; Acute Coronary Syndromes; Unstable Angina
Medicure
 2012-04 PHASE2
NCT03078257 UNKNOWN
Coronary Artery Disease
The First Affiliated Hospital with Nanjing Medical University
 2016-01-01 PHASE1
NCT02131220 COMPLETED
Myocardial Infarction; Percutaneous Coronary Intervention; Thrombolytic Therapy
Fudan University
 2015-11 PHASE4
NCT02294994 UNKNOWN
Coronary Artery Disease
Second Hospital of Jilin University
 2014-11 PHASE4
NCT03114995 COMPLETED
Non-ST Elevation Myocardial Infarction
Seoul National University Bundang Hospital
 2012-02-01 PHASE4
NCT01498003 COMPLETED
Coronary Artery Disease
Shanghai Jiao Tong University School of Medicine
 2011-11 PHASE4
NCT01598337 UNKNOWN
Coronary Artery Disease
Prince Sultan Cardiac Center, Adult Cardiology Department.
 2011-04 PHASE3
NCT02054000 COMPLETED
No-Reflow Phenomenon
TC Erciyes University
 2011-01 PHASE4
NCT01660373 UNKNOWN
Non-ST Segment Elevation Acute Coronary Syndrome
Pusan National University Yangsan Hospital
 2012-08 PHASE3
NCT01696110 COMPLETED
Acute Myocardial Infarction; Percutaneous Coronary Intervention
Shenyang Northern Hospital
 2012-08 PHASE4
NCT01766154 COMPLETED
Renal Insufficiency
Medicure
 2013-01 PHASE1
NCT01181388 UNKNOWN
Myocardial Infarction
Beijing Anzhen Hospital
 2010-04
NCT00300833 UNKNOWN
Acute Myocardial Infarction
The Baruch Padeh Medical Center, Poriya
 2006-01 PHASE4
NCT01336348 COMPLETED
ST Segment Elevation Myocardial Infarction
Università degli Studi di Ferrara
 2010-04 PHASE3
NCT00445263 TERMINATED
CORONARY DISEASE
Hospital Avicenne
 2007-03 PHASE4
NCT01109134 COMPLETED
Acute Myocardial Infarction
Kosuyolu Heart Hospital
 2008-09 PHASE3
NCT00538317 COMPLETED
Acute Myocardial Infarction
Hospices Civils de Lyon
 2007-07 PHASE4
NCT00566891 COMPLETED
Coronary Artery Disease
S. Anna Hospital
 2007-12 PHASE4
NCT00398463 COMPLETED
Angioplasty, Transluminal, Percutaneous Coronary
Università degli Studi di Ferrara
 2006-05 PHASE4
NCT00306228 COMPLETED
Myocardial Infarction
GRACIA Group
 2004-10 PHASE4
NCT00383136 COMPLETED
Acute Myocardial Infarction
University of Bologna
 2003-06 PHASE4
NCT00229515 UNKNOWN
Myocardial Infarction
Marco Valgimigli
 2004-11 PHASE4
NCT00611169 COMPLETED
Acute Myocardial Infarction
Samsung Medical Center
 2006-01 PHASE4
NCT00790387 COMPLETED
Acute Coronary Syndrome
The Prince Charles Hospital
 2004-06 PHASE4
NCT00251576 COMPLETED
Acute Coronary Syndrome
Organon and Co
 1999-11-01 PHASE3
NCT01245725 WITHDRAWN
Myocardial Infarction; Acute Coronary Syndromes; Unstable Angina; Percutaneous Coronary Intervention
Medicure
 PHASE3
NCT00407771 UNKNOWN
Coronary Artery Disease
Jordan Hospital
 2007-11 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-06-25)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tirofiban hydrochloride selectively binds to the platelet membrane glycoprotein IIb/IIIa receptor, reversibly blocking fibrinogen cross-linking and inhibiting platelet aggregation. By suppressing thrombus formation and maintaining vascular patency, this targeted action mitigates ischemic complications in clinical settings such as acute myocardial infarction, acute coronary syndrome, and acute 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>).

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