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Acute Myocardial InfarctionPhase 2NCT03487445

A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack

A Phase 2 study testing Selatogrel 8 mg and Selatogrel 16 mg in people with Acute Myocardial Infarction, run by Viatris Innovation GmbH at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can prevent platelets from binding together. This study will also help to find out more about the safety of this new drug. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Selatogrel 8 mg and Selatogrel 16 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
6 sitesin 3 countries
Study dates
10 Jul 2018to 10 Nov 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  • Informed consent obtained prior to any study-mandated procedure,
  • Males aged from 18 to 85 and postmenopausal females aged up to 85 years,
  • Onset of symptoms of AMI of more than 30 min and less than 6 hours prior to randomization,
  • Subjects presenting a type I AMI including STEMI or NSTEMI.

Main Exclusion Criteria:

  • Cardiogenic shock or severe hemodynamic instability,
  • Cardiopulmonary resuscitation,
  • Loading dose of any oral P2Y12 receptor antagonist prior to randomization,
  • Planned fibrinolytic therapy or any fibrinolytic therapy administered within 24 h prior to randomization,
  • Known platelet disorders (e.g., thromboasthenia, thrombocytopenia, von Willebrand disease).
  • Active internal bleeding, or bleeding diathesis or conditions associated with high risk of bleeding.
  • Known clinically important anemia.
  • Oral anticoagulation therapy within 7 days prior to randomization

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Switzerland3 sites

  • Universitätsspital Basel

    Basel, 4031

  • University Hospital Bern

    Bern, 3010

  • Cardiocentro Ticino

    Lugano, 6900

Other trials in Switzerland

Belgium2 sites

  • OLV Ziekenhuis Aalst

    Aalst, 9300

  • UZLeuven

    Leuven, 3000

Other trials in Belgium

Israel1 site

  • Galilee Medical Center

    Nahariya, 22100

Other trials in Israel

About this study

Official title: A Multi-center, Open-label, Randomized, Study to Assess the Onset of Platelet Aggregation Inhibition After a Single Subcutaneous Injection of ACT-246475 in Adults With Acute Myocardial Infarction

The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can prevent platelets from binding together. This study will also help to find out more about the safety of this new drug. The drug selatogrel (ACT-246475) will be used in 2 different doses (8 mg or 16 mg) and will be administered in the thigh.

Read the detailed description

This study is planned in patients presenting with Acute Myocardial Infarction (AMI) scheduled for an invasive strategy. Platelet activation and thrombus formation play a pivotal role in the pathophysiology of acute coronary syndrome. Early platelet inhibition has been shown to reduce the risk of recurrent events after a myocardial infarction.

The screening period starts when the participant provides informed consent and ends with participant's randomization. Eligible participants had an acute myocardial infarction (AMI; ST-segment elevation myocardial infarction [STEMI] or non-ST-elevation myocardial infarction [NSTEMI]), a life-threatening condition, and will therefore fulfill the ICH-GCP definition of vulnerable subjects ("persons in emergency situations"). Accordingly, a specific process for obtaining consent in compliance with local regulations and approved by the independent ethics committee will be implemented.

The study will be performed during a participant's hospital stay related to the qualifying AMI.

Standard treatment of AMI is allowed including anticoagulants. Ticagrelor will be the only oral P2Y12 receptor antagonist allowed to be initiated during the study and its administration will be possible only after selatogrel administration. Use of fibrinolytics or GPIIb/IIIa inhibitors will be prohibited unless required for bail-out. All other standard-of-care treatments for AMI will be allowed without restriction.

The treatment period starts with the participant's randomization and ends after the end-of-study assessments, approximately 48 hours after the administration of a single study treatment dose.

Being tested
Selatogrel 8 mg, Selatogrel 16 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selatogrel 8 mgDrug

    Also called ACT-246475

    Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water and further diluted with 1 mL sodium chloride (NaCl) 0.9%.

  • Selatogrel 16 mgDrug

    Also called ACT-246475

    Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.

Study groups in NCT03487445
Study groupRoleWhat they receive
Selatogrel 8 mgExperimentalSelatogrel (ACT-246475) is given as a single subcutaneous dose of 8 mg administered in a volume of 0.8 mL. Administration will be performed at the investigational site by qualified personnel.
Receives: Drug: Selatogrel 8 mg
Selatogrel 16 mgExperimentalSelatogrel (ACT-246475) is given as a single subcutaneous dose of 16 mg administered in a volume of 0.8 mL. Administration will be performed at the investigational site by qualified personnel.
Receives: Drug: Selatogrel 16 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation

    The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using the VerifyNow® assay. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU).The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU less than 100 at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response.

    Measured: 30 minutes after the administration of the subcutaneous injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2018
  2. Study start10 Jul 2018
  3. Primary completion10 Nov 2018
  4. Study completion10 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03487445
Sponsor's protocol ID
ID-076A202
Other IDs
2018-000765-36, 2018
Status last verified
Nov 2022
First submitted
26 Mar 2018
Last updated
29 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gurbel PA, Bliden KP, Butler K, Antonino MJ, Wei C, Teng R, Rasmussen L, Storey RF, Nielsen T, Eikelboom JW, Sabe-Affaki G, Husted S, Kereiakes DJ, Henderson D, Patel DV, Tantry US. Response to ticagrelor in clopidogrel nonresponders and responders and effect of switching therapies: the RESPOND study. Circulation. 2010 Mar 16;121(10):1188-99. doi: 10.1161/CIRCULATIONAHA.109.919456. Epub 2010 Mar 1.

    PubMed 20194878

  • Jernberg T, Payne CD, Winters KJ, Darstein C, Brandt JT, Jakubowski JA, Naganuma H, Siegbahn A, Wallentin L. Prasugrel achieves greater inhibition of platelet aggregation and a lower rate of non-responders compared with clopidogrel in aspirin-treated patients with stable coronary artery disease. Eur Heart J. 2006 May;27(10):1166-73. doi: 10.1093/eurheartj/ehi877. Epub 2006 Apr 18.

    PubMed 16621870

  • Parodi G, Bellandi B, Valenti R, Migliorini A, Marcucci R, Carrabba N, Giurlani L, Gensini GF, Abbate R, Antoniucci D. Comparison of double (360 mg) ticagrelor loading dose with standard (60 mg) prasugrel loading dose in ST-elevation myocardial infarction patients: the Rapid Activity of Platelet Inhibitor Drugs (RAPID) primary PCI 2 study. Am Heart J. 2014 Jun;167(6):909-14. doi: 10.1016/j.ahj.2014.03.011. Epub 2014 Apr 4.

    PubMed 24890542

  • Sinnaeve P, Fahrni G, Schelfaut D, Spirito A, Mueller C, Frenoux JM, Hmissi A, Bernaud C, Ufer M, Moccetti T, Atar S, Valgimigli M. Subcutaneous Selatogrel Inhibits Platelet Aggregation in Patients With Acute Myocardial Infarction. J Am Coll Cardiol. 2020 May 26;75(20):2588-2597. doi: 10.1016/j.jacc.2020.03.059.

    PubMed 32439008

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selatogrel 8 mg and Selatogrel 16 mg in people with Acute Myocardial Infarction, run by Viatris Innovation GmbH at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Switzerland, Belgium, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation (time frame: 30 minutes after the administration of the subcutaneous injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03487445, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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