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

NCT03487445 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: ID-076A2022018-000765-36
• Study Type: interventional
• Target: 48
• Locations: 3 countries
• Sites: 6

Brief 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. The drug selatogrel (ACT-246475) will be used in 2 different doses (8 mg or 16 mg) and will be administered in the thigh.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (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.

  30 minutes after the administration of the subcutaneous injection

Other Outcomes (5)

• Number of Participants (Per-protocol Subgroup) With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation

  30 minutes after the administration of the subcutaneous injection

• Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation

  pre-dose, 15, 30 and 60 minutes after the administration of the subcutaneous injection

• Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time

  pre-dose, 15, 30 and 60 minutes after administration of the subcutaneous injection

Study Arms (2)

Selatogrel 8 mg

EXPERIMENTAL

Selatogrel (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.

Drug: Selatogrel 8 mg

Selatogrel 16 mg

EXPERIMENTAL

Selatogrel (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.

Drug: Selatogrel 16 mg

Interventions

Selatogrel 8 mg DRUG

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%.

Also known as: ACT-246475

Selatogrel 8 mg

Selatogrel 16 mg DRUG

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.

Also known as: ACT-246475

Selatogrel 16 mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Viatris Innovation GmbH: lead

Study Sites (6)

OLV Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

UZLeuven

Leuven, 3000, Belgium

Location

Galilee Medical Center

Nahariya, 22100, Israel

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

University Hospital Bern

Bern, 3010, Switzerland

Location

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 20194878 BACKGROUND

• 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.

  PMID: 16621870 BACKGROUND

• 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.

  PMID: 24890542 BACKGROUND

• 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.

  PMID: 32439008 DERIVED

MeSH Terms

Interventions

selatogrel

Limitations and Caveats

The p-values need to be cautiously interpreted due to the small study population size. The participants were expected per protocol to shortly undergo invasive management, it was anticipated that most would receive an early loading dose of ticagrelor. Blood samples were collected with phenylalanine-proline-arginine-chloromethylketone as anticoagulant. Only the VerifyNow® assay was used to assess the platelet response to selatogrel.

Results Point of Contact

• Title: Viatris Innovation Clinical Trial Information
• Organization: Viatris Innovation GmbH

viatrisinnovationclinicaltrials@viatris.com

+41 58 844 07 44

Study Officials

• Clinical Trials

  Viatris Innovation GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 4, 2018
• Study Start: July 10, 2018
• Primary Completion: November 10, 2018
• Study Completion: November 10, 2018
• Last Updated: July 9, 2025
• Results First Posted: August 25, 2021

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3); IL (1); BE (2)