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This document has been superseded by Clinical investigation of new medicinal products for the treatment of acute coronary syndrome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

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

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

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

An update of the Committe for Medicinal Products for Human Use points to consider on new medicinal products for the treatment of acute coronary syndrome is foreseen. This document covers a number of points that are proposed to be addressed in the update.

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)

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