Stable Coronary Artery DiseasePhase 2NCT03384966

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

A Phase 2 study testing Selatogrel in people with Stable Coronary Artery Disease, run by Viatris Innovation GmbH at 20 sites in 8 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

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Stable Coronary Artery Disease
What is being tested?: Selatogrel
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 346 participants
Where: 20 sitesin 8 countries
Study dates: 24 Jan 2018to 18 Sep 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:

Signed informed consent prior to any study-mandated procedure.
Male and female subjects aged from 18-85 years, inclusive.
For women of childbearing potential: Negative urine pregnancy test at Visit 1 and at Visit 2 before randomization.
Stable Coronary artery disease (CAD) defined by the presence of any of the following conditions:
History of CAD with coronary artery stenosis on coronary angiogram ≥50%.
Previously documented myocardial infarction occurring more than 3 months prior to randomization.
Antiplatelet background therapy stable for at least 1 month prior to randomization.
Body weight ≥ 40.0 kg (88.2 lbs).

Main Exclusion Criteria:

Acute coronary syndrome, percutaneous coronary intervention or any intervention for peripheral artery disease within 3 months prior to randomization.
Acute ischemic stroke or transient ischemic attack (TIA) within 3 months prior to randomization.
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).
Hemoglobin ≤ 10 g/dL at screening.
Loss of at least 250 mL of blood within 3 months of screening.
Use of anticoagulants (oral, parenteral) or fibrinolytic therapy within 24 h prior to screening (Visit 1).
Known platelet disorders (e.g., thrombasthenia, thrombocytopenia, von Willebrand disease).
Pregnant or breastfeeding women.

Trial locations and contacts

20 sites in 8 countries.

Country

City, postcode or hospital

20 sites in 8 countries

United States7 sites

NorthShore University
Chicago, Illinois, 73104
Inova Center for Thrombosis Research and Translational Medicine
Falls Church, Virginia, 22042
Indiana University School of Medicine - Krannert Institute of Cardiology
Indianapolis, Indiana, 46202
University of Florida (UF) Jacksonville
Jacksonville, Florida, 32209
Inova Cardiology
Lutherville, Maryland, 21093
Mount Sinai Hospital (New York)
New York, New York, 10029
Florida Hospital Tampa - Pepin Heart Institute
Tampa, Florida, 33613

Other trials in United States

Netherlands3 sites

University Medical Center Groningen
Groningen, 9713 GZ
Maastricht UMC
Maastricht, 6229 HX
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM

Other trials in Netherlands

United Kingdom3 sites

Freeman Hospital - Cardiothoracic Department
Newcastle upon Tyne, NE7 7DN
Sheffield Teaching Hospitals
Sheffield, S5 7AU
East & North Hertfordshire NHS Trust - Lister Hospital
Stevenage, SG14AB

Other trials in United Kingdom

Denmark2 sites

Aarhus University Hospital
Aarhus, 8200
Rigshospitalet
Copenhagen, 2100

Other trials in Denmark

Sweden2 sites

Sahlgrenska University Hospital
Gothenburg, 40530
Uppsala University Hospital
Uppsala, 18288

Other trials in Sweden

Canada1 site

Institut de Cardiologie de Montréal
Montreal, Quebec, H1T 1C8

Other trials in Canada

Germany1 site

Universitats-Herzzentrum
Bad Krozingen, 79189

Other trials in Germany

Singapore1 site

National Heart Centre Singapore
Singapore, 169609

Other trials in Singapore

About this study

Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Pharmacodynamics, Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Injection of ACT-246475 in Adults With Stable Coronary Artery Disease

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.

Read the 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
Being tested: Selatogrel, Placebo
Keywords: Chronic coronary syndrome

What participants receive

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

SelatogrelDrug
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) 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.
PlaceboDrug
Matching placebo for subcutaneous administration.
SelatogrelDrug
Also called ACT-246575
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 NCT03384966
Study group	Role	What they receive
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. Receives: Drug: Selatogrel
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. Receives: Drug: Selatogrel
Placebo	Placebo comparator	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. Receives: Drug: Placebo

What is being measured

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

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 VerifyNow®. 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 of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".
Measured: From 15 minutes after administration of the subcutaneous injection up to 24 hours

Secondary outcomes (3)

Maximum Selatogrel Plasma Concentration (Cmax)
The Cmax is the peak concentration of selatogrel in the plasma after subcutaneous injection.
The pharmacokinetic parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.
Measured: Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours
Time to Reach Maximum Selatogrel Plasma Concentration (Tmax)
Time after subcutaneous injection to reach the maximum observed selatogrel plasma concentration (Cmax).
Measured: Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours
Area Under the Plasma Concentration-time Curve of Selatogrel From Time Zero to 24 Hour Time Point (AUC0-24)
The area under the plasma concentration-time curve is the integral of the concentration-time curve after subcutaneous injection of selatogrel.
The plasma pharmacokinetic parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.
Measured: Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours post-dose

Timeline

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

24 Jan 201818 Sep 2018

First posted28 Dec 2017
Study start24 Jan 2018
Primary completion18 Aug 2018
Study completion18 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stable Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 346 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03384966
Sponsor's protocol ID: ID-076A201
Other IDs: 2017-003332-36, 2017
Status last verified: Nov 2022
First submitted: 20 Dec 2017
Last updated: 29 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31994703

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stable Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Pharmacodynamics, Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Injection of ACT-246475 in Adults With Stable Coronary Artery Disease
ClinicalTrials.gov ID: NCT03384966
Acronym / sponsor ID: ID-076A201
Conditions: Stable Coronary Artery Disease
Keywords: Chronic coronary syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 346 participants (actual)
Lead sponsor: Viatris Innovation GmbHIndustry (pharma, biotech, devices)
Study start: 24 Jan 2018 (actual)
Primary completion: 18 Aug 2018 (actual)
Study completion: 18 Sep 2018 (actual)
First posted: 28 Dec 2017 (actual)
Results: Posted 17 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Selatogrel 8 mg	Experimental	Drug: SelatogrelSelatogrel (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.
Selatogrel 16 mg	Experimental	Drug: SelatogrelSelatogrel (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.
Placebo	Placebo comparator	Drug: PlaceboPlacebo 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SelatogrelAlso: ACT-246475Selatogrel 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.	Drug	Selatogrel 8 mg
PlaceboMatching placebo for subcutaneous administration.	Drug	Placebo
SelatogrelAlso: ACT-246575Selatogrel 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.	Drug	Selatogrel 16 mg

Primary outcome

Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
Time frame: From 15 minutes after administration of the subcutaneous injection up to 24 hours
The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. 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 of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".

3 secondary outcomes

Maximum Selatogrel Plasma Concentration (Cmax)
Time frame: Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours
Time to Reach Maximum Selatogrel Plasma Concentration (Tmax)
Time frame: Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours
Area Under the Plasma Concentration-time Curve of Selatogrel From Time Zero to 24 Hour Time Point (AUC0-24)
Time frame: Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours post-dose

Results and safety

Results posted to the registry on 17 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Selatogrel 8 mg	115	114
Selatogrel 16 mg	115	115
Placebo	116	116

Primary outcome: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation

Time frame: From 15 minutes after administration of the subcutaneous injection up to 24 hours. Number. Unit: Count of participants (i.e., responders)

Measure	Selatogrel 8 mg n = 114	Selatogrel 16 mg n = 115	Placebo n = 116
Value	102	103	18

Selatogrel 8 mg vs Placebo: Odds Ratio (OR): 58.9 (97.5% CI 22.4 to 154.8), p < 0.0001, Chi-squared
Selatogrel 16 mg vs Placebo: Odds Ratio (OR): 61.2 (97.5% CI 23.1 to 162.3), p < 0.0001, Chi-squared

Population analysed: Full Analysis Set - all participants that were randomized and who had study treatment administered.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded up to 35 days after the single subcutaneous selatogrel dose administration. Treatment period: Treatment emergent adverse events were those adverse events with onset and up to 48 hours after study treatment administration. The follow-up period started on Day 3 and ended with the safety follow-up telephone call 35 days after selatogrel administration. During the follow-up period the participants continued to be observed. No interventions were performed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Period - Selatogrel 8 mg	0 of 114 (0%)	36 of 114 (31.6%)	0 of 114
Treatment Period - Selatogrel 16 mg	0 of 115 (0%)	26 of 115 (22.6%)	0 of 115
Treatment Period - Placebo	0 of 116 (0%)	25 of 116 (21.6%)	0 of 116
Follow-up Period - Selatogrel 8 mg	5 of 114 (4.4%)	13 of 114 (11.4%)	1 of 114
Follow-up Period - Selatogrel 16 mg	1 of 115 (0.9%)	10 of 115 (8.7%)	0 of 115
Follow-up Period - Placebo	1 of 116 (0.9%)	13 of 116 (11.2%)	0 of 116

Limitations and caveats (from the sponsor): Blood was collected with phenylalanine-proline-arginine-chloromethyl ketone as anticoagulant. Any direct comparison of absolute PRU values obtained in this study with those published from studies of other P2Y12 inhibitors should take this into account.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31994703Storey 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Viatris Innovation GmbH

20 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selatogrel in people with Stable Coronary Artery Disease, run by Viatris Innovation GmbH at 20 sites in 8 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 20 sites in United States, Netherlands, United Kingdom, Denmark, Sweden and 3 more countries. 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. Some participants in this study may receive a placebo. 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 17 May 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: From 15 minutes after administration of the subcutaneous injection up to 24 hours). 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 NCT03384966, which also lists 1 linked publication.

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.