SOS AMI

A Research Study For People Who Have Recently Suffered A Heart Attack

SOS-AMI is a global phase 3 research study for people who have experienced one or more heart attacks and are at risk of experiencing heart attack(s) again in the future.

The study will assess whether an investigational drug, called selatogrel, can treat a heart attack when self-administered by participants using a study autoinjector.

All participants in the SOS-AMI study will receive training on how and when to use the study autoinjector as well as regular follow-ups with the study team.

What is a research study?

Before a new medication can be approved by health authorities and prescribed by healthcare professionals, thorough and rigorous studies must be conducted in order to assess its effectiveness and safety. There are multiple phases of the research studies that typically span between 5 to 10 years

Most investigational drugs go through three phases of research study

Assess how well healthy people tolerate the investigational drug as well as how safe it is.

Find the optimal dose of the investigational drug to test in phase 3, by evaluating its effectiveness and side effects in a limited number of participants.

Assess the effectiveness and safety of the investigational drug, most often compared to placebo, in a large group of participants.

Read more about research studies from the FDA:
https://www.fda.gov/forpatients/approvals/drugs/ucm405622.htm

SOS-AMI - a phase 3 study

In SOS-AMI, selatogrel will be tested as self-administration. Self-administration means that you have to inject the study drug (selatogrel or placebo) yourself in your thigh or abdomen, when you feel symptoms of a heart attack.

The study drug is contained in a ready-to-use study autoinjector.
The study autoinjectors will be provided to you by your study doctor.

You will receive specific instructions to understand when and
how to use the study autoinjector.