Clinical Trials

Several clinical trials evaluate therapeutic regimens and pharmacodynamic profiles associated with coumarin-related pathway management across conditions including atrial fibrillation, hemodialysis complications, venous thromboembolism, and congenital protein C deficiency. Spanning Phase 2, Phase 2/3, and Phase 4, these completed studies are sponsored by academic institutions, university networks, and pharmaceutical organizations such as Utrecht University, Hospital Universitari de Bellvitge, and Baxalta.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04952792 Completed
Atrial Fibrillation|Hemodialysis Complication
Hospital Universitari de Bellvitge|Spanish Society of Nephrology|Baxter Healthcare Corporation
 2021-05-20 Phase 2
NCT01119300 Completed
Venous Thromboembolism|Atrial Fibrillation
Utrecht Institute for Pharmaceutical Sciences|Utrecht University|Leiden University Medical Center|Erasmus Medical Center|University of Ulm|Newcastle University|University of Liverpool|LGC Limited|Uppsala University|Democritus University of Thrace|Elisabethinen Hospital
 2011-01 Phase 4
NCT00157118 Completed
Protein C Deficiency
Baxalta now part of Shire|Takeda
 2003-08-22 Phase 2|Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Coumarin binds to and inhibits vitamin K epoxide reductase, thereby disrupting the enzymatic recycling of vitamin K and preventing the gamma-carboxylation of essential coagulation factors. This inhibition reduces functional prothrombin and clotting factor synthesis, ultimately impairing the coagulation cascade to prevent thrombus formation in clinical conditions such as atrial fibrillation and venous thromboembolism.

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>).

Jump to

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