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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
Must not have
Current dialysis.
Known liver impairment significantly affecting the hepatic function.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up total duration: up to 30 days
Awards & highlights
Pivotal 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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on dialysis.
Select...
My liver function is significantly impaired.
Select...
I am currently on a combination of blood thinners and antiplatelet medications.
Select...
I have a history of serious bleeding or conditions that increase my risk.
Select...
I am allergic to selatogrel or similar medications.
Select...
My hemoglobin level is below 10 g/dL due to chronic anemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ total duration: up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~total duration: up to 30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 • NCT033849661%
Atrial fibrillation
1%
Non-cardiac chest pain
1%
Syncope
1%
Angina pectoris
1%
Cardiac arrest
1%
Ventricular fibrillation
1%
Oedema peripheral
1%
Dizziness
1%
Vertigo
1%
Malaise
1%
Pain in extremity
1%
Blood glucose increased
1%
Chronic obstructive pulmonary disease
1%
Fatigue
1%
Gastric haemorrhage
1%
Herpes zoster
1%
Myalgia
1%
Nasopharyngitis
1%
Oropharyngeal pain
1%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Follow-up Period - Selatogrel 8 mg
Follow-up Period - Selatogrel 16 mg
Treatment Period - Selatogrel 8 mg
Treatment Period - Selatogrel 16 mg
Treatment Period - Placebo
Follow-up Period - Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
121 Previous Clinical Trials
21,963 Total Patients Enrolled
Clinical TrialsStudy DirectorIdorsia Pharmaceuticals Ltd.
2,233 Previous Clinical Trials
888,237 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on dialysis.My liver function is significantly impaired.I have had a stroke or a mini-stroke in the last 3 months.You have a long-term low platelet count (less than 100,000 platelets per cubic millimeter).I have severe blockage in multiple heart arteries and at least two major health issues like a previous heart attack, diabetes, kidney disease, or poor blood flow in my legs.I had a heart attack within the last 4 weeks.I am currently on a combination of blood thinners and antiplatelet medications.I have a history of serious bleeding or conditions that increase my risk.I am allergic to selatogrel or similar medications.My hemoglobin level is below 10 g/dL due to chronic anemia.
Research Study Groups:
This trial has the following groups:- Group 1: Selatogrel
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.