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Antiplatelet Agent

Selatogrel for Heart Attack (SOS-AMI Trial)

Phase 3
Waitlist Available
Research Sponsored by Idorsia Pharmaceuticals Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up total duration: up to 30 days
Awards & highlights

SOS-AMI Trial Summary

This trial will test if a new drug can help people recently discharged from the hospital with type 1 heart attacks who have other risk factors for heart disease.

Who is the study for?
This trial is for patients who've had a type 1 heart attack within the last 4 weeks and have additional cardiovascular risks like diabetes, kidney disease, or prior heart attacks. They must be able to use an autoinjector and not have severe liver issues, recent strokes, known allergies to P2Y12 drugs like Selatogrel, bleeding risks or be on certain blood thinners.Check my eligibility
What is being tested?
The study tests Selatogrel against a placebo in people who recently had a heart attack. Participants are chosen at random after leaving the hospital to receive either the actual drug or a dummy injection without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects of Selatogrel aren't listed here, similar drugs can cause bleeding problems, bruising easily, shortness of breath and sometimes allergic reactions. The severity varies from person to person.

SOS-AMI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~total duration: up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and total duration: up to 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical status as assessed by a 6-point ordinal scale
Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition
Secondary outcome measures
Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint)

Side effects data

From 2018 Phase 2 trial • 346 Patients • NCT03384966
9%
Dyspnoea
3%
Dizziness
3%
Headache
2%
Injection site pruritus
2%
Injection site bruise
2%
Injection site erythema
1%
Oedema peripheral
1%
Contusion
1%
Vertigo
1%
Nausea
1%
Mouth haemorrhage
1%
Renal impairment
1%
Hypoglycaemia
1%
Ecchymosis
1%
Hypotension
1%
Injection site reaction
1%
Pyrexia
1%
Eye contusion
1%
Procedural dizziness
1%
Hypertension
1%
Muscle spasms
1%
Procedural nausea
1%
ECG P wave inverted
1%
Diarrhoea
1%
Hyperhidrosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Period - Selatogrel 16 mg
Follow-up Period - Placebo
Treatment Period - Placebo
Treatment Period - Selatogrel 8 mg
Follow-up Period - Selatogrel 8 mg
Follow-up Period - Selatogrel 16 mg

SOS-AMI Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SelatogrelExperimental Treatment1 Intervention
Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits.
Group II: PlaceboPlacebo Group1 Intervention
Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selatogrel
2020
Completed Phase 2
~400

Find a Location

Who is running the clinical trial?

Idorsia Pharmaceuticals Ltd.Lead Sponsor
118 Previous Clinical Trials
18,457 Total Patients Enrolled
Clinical TrialsStudy DirectorIdorsia Pharmaceuticals Ltd.
2,199 Previous Clinical Trials
874,502 Total Patients Enrolled

Media Library

Selatogrel (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04957719 — Phase 3
Heart Attack Research Study Groups: Selatogrel, Placebo
Heart Attack Clinical Trial 2023: Selatogrel Highlights & Side Effects. Trial Name: NCT04957719 — Phase 3
Selatogrel (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04957719 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being given the opportunity to participate in this research project?

"Recruitment for this trial is currently inactive. The study was originally posted on 8/14/2021, with the most recent update made on 11/15/2022. There are other research studies you may be eligible for; as of now, there are 373 clinical trials actively admitting patients with infarction and 1 study for Selatogrel looking for participants."

Answered by AI

Is this a unique or innovative clinical trial?

"Selatogrel's clinical trials began in 2021, with the first study being sponsored by Idorsia Pharmaceuticals Ltd. That initial trial included 14000 patients. Selatogrel completed Phase 3 of its drug approval process and is now only undergoing one active trial, again sponsored by Idorsia Pharmaceuticals Ltd."

Answered by AI

Is this trial widely available in North America?

"This clinical trial has 93 active medical sites, including CISSSL - Hopital Pierre-Le Gardeur in Terrebonne, Inova Heart & Vascular Institute in Falls Church, and Advanced Heart Care, LLC in Bridgewater."

Answered by AI

Are there still available slots where people can enroll in this clinical trial?

"At present, this clinical trial is not recruiting patients. The study was first posted on August 14th, 2021 and was last updated on November 15th, 2022. For individuals seeking other studies, there are currently 373 trials actively recruiting patients for infarction and 1 Selatogrel trial also looking for participants."

Answered by AI

Does Selatogrel put patients at risk?

"Selatogrel has received a 3 for safety from our team at Power. This is due to the fact that Selatogrel is in Phase 3 trials, which suggests that not only does some data support efficacy, but multiple rounds of data support safety."

Answered by AI

Are there any other similar drugs to Selatogrel that have been trialed before?

"Currently, there is 1 clinical trial for Selatogrel that is still ongoing and in Phase 3. However, most of the research conducted on Selatogrel has taken place in 's-Hertogenbosch and British Columbia. In total, 314 different locations have been used to study Selatogrel."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Covenant Medical Group d/b/a Parkway Cardiology Associates
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've been looking at doing clinical trials for few months but it's hard to find one that fits and this one is even close to home. I want to be a part of something bigger than me. Plus extra income is always a plus.
PatientReceived 1 prior treatment
Recent research and studies
~4468 spots leftby Aug 2025