A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease

NCT ID: NCT03384966

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-24
• Study Completion Date: 2018-09-18

Brief Summary

The goal of this study is to find out if a drug called selatogrel (ACT-246475) can prevent platelets from binding together when administered by an injection under the skin in the thigh or in the belly. Another goal is to know how fast and for how long selatogrel (ACT-246475) works and if there is a difference if the drug is injected in the thigh or in the belly. This study will also help to find out more about the safety of this new drug.

Detailed Description

To investigate the pharmacodynamic (PD) and pharmacokinetic (PK) properties of selatogrel in patients with atherosclerotic disease, the present study will be conducted in patients with chronic coronary syndromes (CCS). Assessment in a population of patients with CCS allows better control and stability of concomitant treatments, and therefore more accurate characterization of the pharmacodynamic and pharmacokinetic profiles of selatogrel in the presence of background antiplatelet therapies.

The study will have 3 periods: a screening period of up to 21 days prior to randomization, a treatment period of 2 days from randomization (Day 1) to 24 hours post dose (Day 2), and a follow-up period from Day 3 to the safety follow-up telephone call 28 to 35 days after single administration of study drug (End-of-Study).

Conditions

Stable Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Selatogrel 8 mg

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.

Group Type: EXPERIMENTAL

Selatogrel

Intervention Type: 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) or matching placebo will be reconstituted with 1 mL of water for injection. Further dilution with 1 mL sodium chloride (NaCl) 0.9% will be performed for preparation of the dose of 8 mg selatogrel.

Selatogrel 16 mg

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.

Group Type: EXPERIMENTAL

Selatogrel

Intervention Type: 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.

Placebo

Placebo matching ACT-246475 is supplied in sealed glass vials for reconstitution with water for injection. Placebo will be given as a single subcutaneous dose matching selatogrel to be administered in a volume of 0.8 mL. Administration will performed at the investigational site by qualified personnel.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo for subcutaneous administration.

Interventions

Selatogrel

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) or matching placebo will be reconstituted with 1 mL of water for injection. Further dilution with 1 mL sodium chloride (NaCl) 0.9% will be performed for preparation of the dose of 8 mg selatogrel.

Intervention Type: DRUG

Placebo

Matching placebo for subcutaneous administration.

Intervention Type: DRUG

Selatogrel

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.

Intervention Type: DRUG

Other Intervention Names

ACT-246475; ACT-246575

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent prior to any study-mandated procedure.

2. Male and female subjects aged from 18-85 years, inclusive.

3. For women of childbearing potential: Negative urine pregnancy test at Visit 1 and at Visit 2 before randomization.

4. Stable Coronary artery disease (CAD) defined by the presence of any of the following conditions:

1. History of CAD with coronary artery stenosis on coronary angiogram ≥50%.

2. Previously documented myocardial infarction occurring more than 3 months prior to randomization.

5. Antiplatelet background therapy stable for at least 1 month prior to randomization.

6. Body weight ≥ 40.0 kg (88.2 lbs).

Exclusion Criteria

1. Acute coronary syndrome, percutaneous coronary intervention or any intervention for peripheral artery disease within 3 months prior to randomization.

2. Acute ischemic stroke or transient ischemic attack (TIA) within 3 months prior to randomization.

3. Active internal bleeding, or medical history of recent (< 1 month) bleeding disorders or conditions associated with high risk of bleeding (e.g., clotting disturbances, gastrointestinal bleed, hemoptysis).

4. Hemoglobin ≤ 10 g/dL at screening.

5. Loss of at least 250 mL of blood within 3 months of screening.

6. Use of anticoagulants (oral, parenteral) or fibrinolytic therapy within 24 h prior to screening (Visit 1).

7. Known platelet disorders (e.g., thrombasthenia, thrombocytopenia, von Willebrand disease).

8. Pregnant or breastfeeding women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Viatris Innovation GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Viatris Innovation GmbH

Locations

University of Florida (UF) Jacksonville

Jacksonville, Florida, United States

Florida Hospital Tampa - Pepin Heart Institute

Tampa, Florida, United States

NorthShore University

Chicago, Illinois, United States

Indiana University School of Medicine - Krannert Institute of Cardiology

Indianapolis, Indiana, United States

Inova Cardiology

Lutherville, Maryland, United States

Mount Sinai Hospital (New York)

New York, New York, United States

Inova Center for Thrombosis Research and Translational Medicine

Falls Church, Virginia, United States

Institut de Cardiologie de Montréal

Montreal, Quebec, Canada

Aarhus University Hospital

Aarhus, , Denmark

Rigshospitalet

Copenhagen, , Denmark

Universitats-Herzzentrum

Bad Krozingen, , Germany

University Medical Center Groningen

Groningen, , Netherlands

Maastricht UMC

Maastricht, , Netherlands

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

National Heart Centre Singapore

Singapore, , Singapore

Sahlgrenska University Hospital

Gothenburg, , Sweden

Uppsala University Hospital

Uppsala, , Sweden

Freeman Hospital - Cardiothoracic Department

Newcastle upon Tyne, , United Kingdom

Sheffield Teaching Hospitals

Sheffield, , United Kingdom

East & North Hertfordshire NHS Trust - Lister Hospital

Stevenage, , United Kingdom

Countries

United States; Canada; Denmark; Germany; Netherlands; Singapore; Sweden; United Kingdom

References

Storey RF, Gurbel PA, Ten Berg J, Bernaud C, Dangas GD, Frenoux JM, Gorog DA, Hmissi A, Kunadian V, James SK, Tanguay JF, Tran H, Trenk D, Ufer M, Van der Harst P, Van't Hof AWJ, Angiolillo DJ. Pharmacodynamics, pharmacokinetics, and safety of single-dose subcutaneous administration of selatogrel, a novel P2Y12 receptor antagonist, in patients with chronic coronary syndromes. Eur Heart J. 2020 Sep 1;41(33):3132-3140. doi: 10.1093/eurheartj/ehz807.

Reference Type: DERIVED

PMID: 31994703 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-003332-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ID-076A201

Identifier Type: -

Identifier Source: org_study_id