Acetyl Coenzyme A trisodium Clinical Trials

Size	Price	Qty
5mg	USD 197

Clinical Trials

A completed clinical trial sponsored by the academic institution Cliniques universitaires Saint-Luc- Université Catholique de Louvain investigated metabolic pathways involving acetyl coenzyme A. Conducted without a formal phase designation, the study evaluated the phosphorylation state of acetyl-coenzyme A carboxylase in blood platelets among patients diagnosed with cardiovascular disorders, specifically coronary artery disease, acute coronary syndrome, and coronary thrombosis. These efforts underscore the therapeutic and diagnostic relevance of acetyl coenzyme A regulation in human atherothrombotic vascular disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03034148	COMPLETED	Coronary Artery Disease; Acute Coronary Syndrome; Coronary Thrombosis	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	2015-03

(data from https://clinicaltrials.gov, updated on 2017-02-17)

Check the Acetyl Coenzyme A trisodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Acetyl coenzyme A functions as a crucial metabolic substrate that donates acetyl groups to acetyltransferases, thereby regulating protein acetylation dynamics, tricarboxylic acid cycle flux, and cellular autophagic processes. This central metabolic regulation directly modulates cellular energy homeostasis and thrombotic signaling, which is clinically relevant to understanding vascular alterations in conditions such as coronary artery disease, acute coronary syndrome, and coronary thrombosis.

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>).