Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Viatris Innovation GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

12 Jan 2022 → ongoing

Decision date (initial)

2024-03-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-505438-85-00

EudraCT number

2020-000983-41

ClinicalTrials.gov

NCT04957719

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety, Pharmacoeconomic

The primary objective of the study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in subjects at risk of having a recurrent AMI.

Secondary objectives 1

1. The secondary objective is to assess the safety of self-administration of selatogrel.

Conditions and MedDRA coding

Acute myocardial infarction (AMI)

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, European Medicines Agency, European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Signed and dated informed consent prior to any study-mandated procedure.
2. Male or female subject ≥ 18 years old at the time of signing the informed consent form.
3. Confirmed diagnosis of symptomatic Type 1 acute myocardial infarction ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial infarction (NSTEMI), no longer than 4 weeks prior to randomization.
4. Diagnosis of multivessel coronary artery disease defined as ≥ 50% stenosis on 2 or more coronary artery territories, including the left main artery, during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 1 of the following risk factors: - Second prior AMI, - Diabetes mellitus defined by ongoing glucose lowering treatment, - CKD defined as eGFR < 60 mL/min/1.73 m2 and either known history of CKD or a biomarker of chronic kidney damage,, - Peripheral artery disease at any time prior to randomization, - Absence of, or unsuccessful coronary revascularization of the qualifying AMI.
5. Successfully self-administered placebo according to the autoinjector Instructions for use during screening.

Exclusion criteria 7

1. Increased risk of serious bleeding including any of the following: - History of intracranial bleed at any time. - Known uncorrected intracranial vascular abnormality. - Gastrointestinal bleed requiring hospitalization or transfusion within 1 year prior to screening. - Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapy and oral anticoagulant). - Known liver impairment significantly affecting the hepatic function. - Current dialysis. - For all countries, except Finland: Ischemic stroke or transient ischemic attack within 3 months prior to screening. For Finland: Ischemic stroke or transient ischemic attack within 1 year prior to screening.
2. Chronic anemia with hemoglobin 10 g/dL.
3. Chronic thrombocytopenia with platelet count 100,000/mm3.
4. Concomitant diseases or conditions that, in the opinion of the investigator, are not compatible with study participation.
5. Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.
6. Previous exposure to an investigational drug within 3 months prior to randomization.
7. Participation in another clinical trial with an investigational product or device within 3 months prior to randomization.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Efficacy: Occurrence of death or non-fatal AMI after any study treatment self-administration. The outcome will be ranked from most to least severe: 1. Death (all causes)* 2. AMI with compromised electro-hemodynamics** 3. STEMI** 4 .High-risk NSTEMI** 5. NSTEMI with peak cardiac troponin > 10 × upper limit of normal** 6. None of the above within *7/**2 days after each treatment administration Only the worst outcome will be retained as the primary endpoint.
2. Safety: Occurrence of type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition, within 2 days after study treatment administration.

Secondary endpoints 1

1. Occurrence of death, non-fatal AMI, hospitalization or unplanned emergency department visit for heart failure, within 30 days after any treatment administration (composite endpoint).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Viatris Innovation GmbH

Sponsor organisation

Viatris Innovation GmbH

Address

Gewerbestrasse 14

City

Allschwil

Postcode

4123

Country

Switzerland

Scientific contact point

Organisation

Viatris Innovation GmbH

Contact name

EUClinicalTrials@viatris

Public contact point

Organisation

Viatris Innovation GmbH

Contact name

EUClinicalTrials@viatris

Third parties 14

Locations

23 EU/EEA countries · 320 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 212 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

34 submissions — initial application plus substantial / non-substantial modifications