Clinical development of fibrinolytic medicinal products in the treatment of patients with ST -segment elevation acute myocardial infarction (STEMI) - Scientific guideline

This document provides guidance on the clinical development of new fibrinolytics in the treatment of patients with ST segment elevation acute myocardial infarction.

Keywords: ST segment elevation, acute coronary syndrome, myocardial infarction, angina, revascularisation, anticoagulants, antithrombotics, stent thrombosis

This document has been superseded by Clinical investigation of new medicinal products for the treatment of acute coronary syndrome

Document history - Revision 1

Draft guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version

Draft: consultation closed Consultation dates: 27/04/2016 to 31/10/2016 Reference Number: EMA/CHMP/207892/2015 Summary:

Two CHMP guidelines have been previously developed to address clinical investigations of new medicinal products for the treatment of acute coronary syndrome (ACS).

Concept paper on the need for revision of the points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version

Draft: consultation closed Consultation dates: 15/10/2014 to 15/01/2015 Reference Number: EMA/CHMP/559636/2014

Document history - First version

Points to consider on the clinical development of fibrinolytic medicinal products in the treatment of patients with st segment elevation acute myocardial infarction (STEMI)

Adopted Reference Number: CPMP/EWP/967/01 Legal effective date: 01/12/2003