A Phase 2 interventional study of Selatogrel and Placebo in Stable Coronary Artery Disease, sponsored by Viatris Innovation GmbH. Completed at 20 sites in 8 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Viatris Innovation GmbH (part of Viatris Inc.) · Phase 2, Interventional, and Treatment
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.
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).
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 346 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Viatris Innovation GmbH is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Stable Coronary artery disease (CAD) defined by the presence of any of the following conditions:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Drug: Placebo
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.
Also known as: ACT-246475
Matching placebo for subcutaneous administration.
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-246575
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".
Time frame: From 15 minutes after administration of the subcutaneous injection up to 24 hours
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.
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 after subcutaneous injection to reach the maximum observed selatogrel plasma concentration (Cmax).
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)
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.
Time frame: Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours post-dose
Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation by Site of Treatment Administration (Thigh or Abdomen)
The inhibition of platelet aggregation based on the route of administration, i.e. whether the pharmacodynamic response was different if selatogrel was administered subcutaneously in the thigh or in the abdomen, was analyzed. 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".
Time frame: From 15 minutes after administration of the subcutaneous injection up to 24 hours
Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation - Sensitivity Analysis
To assess the robustness of results for the pharmacodynamic response, the main analysis was repeated for the per protocol participants. 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".
Time frame: From 15 minutes after administration of the subcutaneous injection up to 24 hours
Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA)
Light transmission aggregometry was used as complementary method to the VerifyNow® to evaluate the effect of selatogrel on platelet aggregation. Platelet aggregation was triggered by addition of Adenosine diphosphate (ADP) 20 µM (micromole per liter) and monitored over 6 minutes. Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with 20 µM ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA % reflects stronger platelet inhibition, whereas a higher MPA % reflects weaker inhibition.
Time frame: Pre-dose, and from 30 minutes after administration of the subcutaneous injection up to 8 hours
Number of Participants With Bleeding Events
Treatment-emergent adverse events in the category "Haemorrhage (excluding laboratory terms)" were of special interest and their incidence listed below. The role of the Independent Safety Event Committee was to monitor unblinded safety data obtained in the study, with a specific focus on study-drug-related clinically relevant major bleeding events, occurring within 48 hours after dosing (i.e. the treatment period).
Time frame: From study treatment administration on Day 1 up to 48 hours
The study was conducted between 24 Jan and 18 Sep 2018. Twenty sites in 8 countries screened 362 participants and 17 sites randomized 346 participants.
| Milestone | Selatogrel 8 mg | Selatogrel 16 mg | Placebo |
|---|---|---|---|
| Started | 115 | 115 | 116 |
| Completed | 114 | 115 | 116 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Physician decision due to adverse event | 1 | 0 | 0 |
| Milestone | Selatogrel 8 mg | Selatogrel 16 mg | Placebo |
|---|---|---|---|
| Started | 114 | 115 | 116 |
| Thigh administration | 57 | 57 | 58 |
| Abdomen administration | 57 | 58 | 58 |
| Per-protocol analysis set | 96 | 90 | 93 |
| Safety analysis set | 114 | 115 | 116 |
| Pharmacokinetic analysis set | 111 | 115 | 0 |
| Completed | 114 | 115 | 116 |
| Not completed | 0 | 0 | 0 |
| Milestone | Selatogrel 8 mg | Selatogrel 16 mg | Placebo |
|---|---|---|---|
| Started | 114 | 115 | 116 |
| Completed | 113 | 115 | 116 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
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".
| Count of participants (i.e., responders) | Selatogrel 8 mg | Selatogrel 16 mg | Placebo |
|---|---|---|---|
| Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | 102 | 103 | 18 |
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.
| ng/mL | Selatogrel 8 mg | Selatogrel 16 mg |
|---|---|---|
| Maximum Selatogrel Plasma Concentration (Cmax) | 298 (146 to 868) | 484 (161 to 1030) |
Time after subcutaneous injection to reach the maximum observed selatogrel plasma concentration (Cmax).
| hour | Selatogrel 8 mg | Selatogrel 16 mg |
|---|---|---|
| Time to Reach Maximum Selatogrel Plasma Concentration (Tmax) | 0.52 (0.38 to 1.05) | 0.53 (0.23 to 2.02) |
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.
| hours*ng/mL | Selatogrel 8 mg | Selatogrel 16 mg |
|---|---|---|
| Area Under the Plasma Concentration-time Curve of Selatogrel From Time Zero to 24 Hour Time Point (AUC0-24) | 716 (347 to 1425) | 1358 (487 to 2758) |
The inhibition of platelet aggregation based on the route of administration, i.e. whether the pharmacodynamic response was different if selatogrel was administered subcutaneously in the thigh or in the abdomen, was analyzed. 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".
| Count of participants (i.e., responders) | Selatogrel 8 mg (Thigh) | Selatogrel 8 mg (Abdomen) | Selatogrel 16 mg (Thigh) | Selatogrel 16 mg (Abdomen) | Placebo (Thigh) | Placebo (Abdomen) |
|---|---|---|---|---|---|---|
| Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation by Site of Treatment Administration (Thigh or Abdomen) | 52 | 50 | 52 | 51 | 11 | 7 |
To assess the robustness of results for the pharmacodynamic response, the main analysis was repeated for the per protocol participants. 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".
| Count of participants (i.e., responders) | Selatogrel 8 mg | Selatogrel 16 mg | Placebo |
|---|---|---|---|
| Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation - Sensitivity Analysis | 92 | 90 | 16 |
Light transmission aggregometry was used as complementary method to the VerifyNow® to evaluate the effect of selatogrel on platelet aggregation. Platelet aggregation was triggered by addition of Adenosine diphosphate (ADP) 20 µM (micromole per liter) and monitored over 6 minutes. Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with 20 µM ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA % reflects stronger platelet inhibition, whereas a higher MPA % reflects weaker inhibition.
| percent maximum platelet aggregation (%) | Selatogrel 8 mg | Selatogrel 16 mg | Placebo |
|---|---|---|---|
| Pre-dose | 61.9 ± 29.79 | 62.4 ± 31.5 | 65.6 ± 29.6 |
| 30 minutes post-dose | 13.1 ± 12.1 | 13.5 ± 11.9 | 65.3 ± 28.0 |
| 1 hour post-dose | 14.5 ± 14.1 | 15.8 ± 15.7 | 65.6 ± 28.0 |
| 2 hours post-dose | 17.0 ± 12.8 | 16.5 ± 14.5 | 63.0 ± 26.8 |
| 8 hours post-dose | 35.4 ± 25.5 | 32.1 ± 25.1 | 63.7 ± 27.0 |
Treatment-emergent adverse events in the category "Haemorrhage (excluding laboratory terms)" were of special interest and their incidence listed below. The role of the Independent Safety Event Committee was to monitor unblinded safety data obtained in the study, with a specific focus on study-drug-related clinically relevant major bleeding events, occurring within 48 hours after dosing (i.e. the treatment period).
| Participants | Selatogrel 8 mg | Selatogrel 16 mg | Placebo |
|---|---|---|---|
| All participants with at least one "bleeding event" | 11 | 5 | 8 |
| Participants with Trombolysis In Myocardial Infarction (TIMI) major events | 0 | 0 | 0 |
| Participants with "Bleeding event of moderate intensity" | 0 | 0 | 1 |
| Participants with "Bleeding event of mild intensity" | 11 | 5 | 7 |
| Injection site bruising | 3 | 2 | 0 |
| Contusion | 1 | 1 | 3 |
| Ecchymosis | 0 | 1 | 0 |
| Eye contusion | 0 | 1 | 0 |
| Medical device site bruise | 1 | 0 | 0 |
| Mouth haemorrhage | 0 | 1 | 0 |
| Vessel puncture site bruise | 4 | 0 | 3 |
| Epistaxis | 1 | 0 | 0 |
| Vessel puncture site haematoma | 1 | 0 | 0 |
| Petechiae | 0 | 0 | 1 |
| Vaginal haemorrhage | 0 | 0 | 1 |
| Wound haemorrhage | 0 | 0 | 1 |
The inhibition of platelet aggregation was determined using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). After single-dose administration the inhibition of platelet aggregation was measured at pre-defined timepoints to observe the platelet reactivity and aggregation over a 24-hour timeperiod. A lower PRU reflects lower platelet reactivity, whereas a higher PRU reflects higher platelet reactivity.
| P2Y12 reaction units | Selatogrel 8 mg | Selatogrel 16 mg | Placebo |
|---|---|---|---|
| Baseline (pre-dose) | 156.1 (142.9 to 169.3) | 156.2 (142 to 170.5) | 155.2 (141.9 to 168.6) |
| 15 minutes post-dose | 10.1 (5.3 to 14.9) | 4.5 (2.6 to 6.4) | 163.3 (149.5 to 177.2) |
| 30 minutes post-dose | 7.9 (3.6 to 12.2) | 5.3 (3.4 to 7.2) | 162.2 (147.9 to 176.4) |
| 1 hour post-dose | 9.7 (4.5 to 14.8) | 3.5 (2.6 to 4.5) | 161.8 (148.6 to 175.0) |
| 2 hours post-dose | 12.4 (7.0 to 17.8) | 5.7 (3.7 to 7.6) | 162.0 (148.5 to 175.4) |
| 4 hours post-dose | 30.1 (22.9 to 37.3) | 11.4 (7.8 to 14.9) | 162.4 (148.8 to 176.0) |
| 8 hours post-dose | 88.1 (76.6 to 99.7) | 47.3 (38.9 to 55.6) | 164.1 (150.6 to 177.6) |
| 24 hours post-dose | 144.2 (130.2 to 158.1) | 128.6 (116.3 to 140.9) | 153.3 (139.4 to 167.2) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Period - Selatogrel 8 mg | 0/114 (0%) | 0/114 (0%) | 36/114 (31.6%) |
| Treatment Period - Selatogrel 16 mg | 0/115 (0%) | 0/115 (0%) | 26/115 (22.6%) |
| Treatment Period - Placebo | 0/116 (0%) | 0/116 (0%) | 25/116 (21.6%) |
| Follow-up Period - Selatogrel 8 mg | 1/114 (0.9%) | 5/114 (4.4%) | 13/114 (11.4%) |
| Follow-up Period - Selatogrel 16 mg | 0/115 (0%) | 1/115 (0.9%) | 10/115 (8.7%) |
| Follow-up Period - Placebo | 0/116 (0%) | 1/116 (0.9%) | 13/116 (11.2%) |
| Event | Treatment Period - Selatogrel 8 mg | Treatment Period - Selatogrel 16 mg | Treatment Period - Placebo | Follow-up Period - Selatogrel 8 mg | Follow-up Period - Selatogrel 16 mg | Follow-up Period - Placebo |
|---|---|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 0/114 | 0/115 | 0/116 | 1/114 | 0/115 | 0/116 |
| SyncopeNervous system disorders | 0/114 | 0/115 | 0/116 | 1/114 | 0/115 | 0/116 |
| Non-cardiac chest painGeneral disorders | 0/114 | 0/115 | 0/116 | 1/114 | 0/115 | 0/116 |
| Angina pectorisCardiac disorders | 0/114 | 0/115 | 0/116 | 1/114 | 0/115 | 0/116 |
| Cardiac arrestCardiac disorders | 0/114 | 0/115 | 0/116 | 1/114 | 0/115 | 0/116 |
| Ventricular fibrillationCardiac disorders | 0/114 | 0/115 | 0/116 | 1/114 | 0/115 | 0/116 |
| CostochondritisMusculoskeletal and connective tissue disorders | 0/114 | 0/115 | 0/116 | 0/114 | 1/115 | 0/116 |
| Myocardial infarctionsCardiac disorders | 0/114 | 0/115 | 0/116 | 0/114 | 0/115 | 1/116 |
| Event | Treatment Period - Selatogrel 8 mg | Treatment Period - Selatogrel 16 mg | Treatment Period - Placebo | Follow-up Period - Selatogrel 8 mg | Follow-up Period - Selatogrel 16 mg | Follow-up Period - Placebo |
|---|---|---|---|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 6/114 | 10/115 | 0/116 | 1/114 | 0/115 | 0/116 |
| DizzinessNervous system disorders | 5/114 | 4/115 | 1/116 | 1/114 | 0/115 | 0/116 |
| HeadacheNervous system disorders | 3/114 | 3/115 | 5/116 | 0/114 | 0/115 | 0/116 |
| Vessel puncture site bruiseGeneral disorders | 4/114 | 0/115 | 3/116 | 0/114 | 0/115 | 0/116 |
| DiarrhoeaGastrointestinal disorders | 4/114 | 1/115 | 0/116 | 0/114 | 2/115 | 1/116 |
| Injection site bruiseGeneral disorders | 3/114 | 2/115 | 0/116 | 0/114 | 0/115 | 0/116 |
| ContusionInjury, poisoning and procedural complications | 1/114 | 1/115 | 3/116 | 0/114 | 1/115 | 0/116 |
| Vessel puncture site erythemaGeneral disorders | 2/114 | 0/115 | 0/116 | 0/114 | 0/115 | 0/116 |
| PresyncopeNervous system disorders | 2/114 | 0/115 | 0/116 | 0/114 | 0/115 | 0/116 |
| Injection site erythemaGeneral disorders | 0/114 | 2/115 | 0/116 | 0/114 | 0/115 | 0/116 |
Full Analysis Set - all participants that were randomized and who had study treatment administered.
| Age, Categorical(Participants) | Selatogrel 8 mg | Selatogrel 16 mg | Placebo | Total |
|---|---|---|---|---|
| Full analysis set — <=18 years | 0 | 0 | 0 | 0 |
| Full analysis set — Between 18 and 65 years | 48 | 48 | 55 | 151 |
| Full analysis set — >=65 years | 66 | 67 | 61 | 194 |
| Per-protocol analysis set — <=18 years | 0 | 0 | 0 | 0 |
| Per-protocol analysis set — Between 18 and 65 years | 41 | 36 | 43 | 120 |
| Per-protocol analysis set — >=65 years | 55 | 54 | 50 | 159 |
| Age, Continuous(years) | Selatogrel 8 mg | Selatogrel 16 mg | Placebo | Total |
|---|---|---|---|---|
| Full analysis set | 64.8 ± 9.4 | 65.2 ± 8.5 | 64.9 ± 9.1 | 65.0 ± 9.0 |
| Per-protocol analysis set | 64.4 ± 9.7 | 65.3 ± 8.8 | 65.1 ± 9.2 | 64.9 ± 9.2 |
| Sex: Female, Male(Participants) | Selatogrel 8 mg | Selatogrel 16 mg | Placebo | Total |
|---|---|---|---|---|
| Full analysis set — Female | 20 | 26 | 23 | 69 |
| Full analysis set — Male | 94 | 89 | 93 | 276 |
| Per-protocol analysis set — Female | 16 | 17 | 16 | 49 |
| Per-protocol analysis set — Male | 80 | 73 | 77 | 230 |
| Ethnicity (NIH/OMB)(Participants) | Selatogrel 8 mg | Selatogrel 16 mg | Placebo | Total |
|---|---|---|---|---|
| Full analysis set — Hispanic or Latino | 1 | 1 | 0 | 2 |
| Full analysis set — Not Hispanic or Latino | 113 | 114 | 116 | 343 |
| Full analysis set — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Per-protocol analysis set — Hispanic or Latino | 1 | 1 | 0 | 2 |
| Per-protocol analysis set — Not Hispanic or Latino | 95 | 89 | 93 | 277 |
| Per-protocol analysis set — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Selatogrel 8 mg | Selatogrel 16 mg | Placebo | Total |
|---|---|---|---|---|
| Full analysis set — American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Full analysis set — Asian | 7 | 6 | 4 | 17 |
| Full analysis set — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Full analysis set — Black or African American | 10 | 13 | 9 | 32 |
| Full analysis set — White | 97 | 96 | 103 | 296 |
| Full analysis set — More than one race | 0 | 0 | 0 | 0 |
| Full analysis set — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Per-protocol analysis set — American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Per-protocol analysis set — Asian | 7 | 5 | 4 | 16 |
| Per-protocol analysis set — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Per-protocol analysis set — Black or African American | 8 | 6 | 7 | 21 |
| Per-protocol analysis set — White | 81 | 79 | 82 | 242 |
| Per-protocol analysis set — More than one race | 0 | 0 | 0 | 0 |
| Per-protocol analysis set — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Selatogrel 8 mg | Selatogrel 16 mg | Placebo | Total |
|---|---|---|---|---|
| Canada | 1 | 1 | 4 | 6 |
| Sweden | 7 | 13 | 10 | 30 |
| Netherlands | 25 | 19 | 21 | 65 |
| Singapore | 4 | 2 | 2 | 8 |
| United States | 52 | 50 | 51 | 153 |
| Denmark | 0 | 1 | 0 | 1 |
| United Kingdom | 22 | 28 | 27 | 77 |
| Germany | 3 | 1 | 1 | 5 |
| Body Mass Index(kilograms per square meter (kg/m^2)) | Selatogrel 8 mg | Selatogrel 16 mg | Placebo | Total |
|---|---|---|---|---|
| Full analysis set | 29 ± 5 | 29 ± 6 | 31 ± 5 | 30 ± 5 |
| Per-protocol analysis set | 29 ± 5 | 29 ± 5 | 30 ± 5 | 29 ± 5 |
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Studies of the drug tested here: Selatogrel