Acute Myocardial Infarction
Conditions
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.
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.
Interventions
DRUGSelatogrel 8 mg
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%.
DRUGSelatogrel 16 mg
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.
Sponsors
Viatris Innovation GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | 30 minutes after the administration of the subcutaneous injection | 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. |
Countries
Belgium, Israel, Switzerland
Contacts
STUDY_DIRECTORClinical Trials
Viatris Innovation GmbH
Participant flow
Recruitment details
The study was conducted between 10 July and 10 November 2018. Seven sites were initiated. Six sites in 3 countries screened and randomized 48 participants.
Pre-assignment details
Forty-eight patients were randomized to either selatogrel 8 mg or 16 mg. Forty-seven patients were administered selatogrel and completed the study. One patient randomized to the 8 mg group did not receive selatogrel (not treated for administrative reasons) and was excluded from the full-analysis set (FAS).
Participants by arm
| Arm | Count |
|---|---|
| Selatogrel 8 mg A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh. | 24 |
| Selatogrel 16 mg A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh. | 23 |
| Total | 47 |
Baseline characteristics
| Characteristic | Selatogrel 8 mg | Total | Selatogrel 16 mg |
|---|---|---|---|
| Age, Categorical Full Analysis Set <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Full Analysis Set >=65 years | 15 Participants | 30 Participants | 15 Participants |
| Age, Categorical Full Analysis Set Between 18 and 65 years | 9 Participants | 17 Participants | 8 Participants |
| Age, Categorical Per Protocol Set <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Per Protocol Set >=65 years | 11 Participants | 24 Participants | 13 Participants |
| Age, Categorical Per Protocol Set Between 18 and 65 years | 9 Participants | 16 Participants | 7 Participants |
| Age, Continuous Full Analysis Set | 65.5 years STANDARD_DEVIATION 11.3 | 66.7 years STANDARD_DEVIATION 10.8 | 68.0 years STANDARD_DEVIATION 10.3 |
| Age, Continuous Per Protocol Set | 64.5 years STANDARD_DEVIATION 12.1 | 66.2 years STANDARD_DEVIATION 11.3 | 67.9 years STANDARD_DEVIATION 10.3 |
| Body Mass Index Full Analysis Set | 28.00 kilograms per square meter STANDARD_DEVIATION 4.83 | 27.40 kilograms per square meter STANDARD_DEVIATION 4.33 | 26.78 kilograms per square meter STANDARD_DEVIATION 3.74 |
| Body Mass Index Per Protocol Set | 27.64 kilograms per square meter STANDARD_DEVIATION 4.88 | 27.16 kilograms per square meter STANDARD_DEVIATION 4.34 | 26.67 kilograms per square meter STANDARD_DEVIATION 3.79 |
| Diagnosis at enrollment NSTEMI | 8 Participants | 18 Participants | 10 Participants |
| Diagnosis at enrollment STEMI | 16 Participants | 29 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Full Analysis Set Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Full Analysis Set Not Hispanic or Latino | 24 Participants | 47 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Full Analysis Set Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Per Protocol Set Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Per Protocol Set Not Hispanic or Latino | 20 Participants | 40 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Per Protocol Set Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Medical history risk factors at baseline Chronic Kidney disease | 0 Participants | 3 Participants | 3 Participants |
| Medical history risk factors at baseline Diabetes mellitus | 8 Participants | 13 Participants | 5 Participants |
| Medical history risk factors at baseline Dyslipidemia | 8 Participants | 18 Participants | 10 Participants |
| Medical history risk factors at baseline Hypertension | 15 Participants | 27 Participants | 12 Participants |
| NSTEMI: Thrombolysis in myocardial infarction (TIMI) risk score NSTEMI: TIMI risk score 5 and above | 2 Participants | 6 Participants | 4 Participants |
| NSTEMI: Thrombolysis in myocardial infarction (TIMI) risk score NSTEMI: TIMI risk score less than 5 | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) Full Analysis Set American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Full Analysis Set Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Full Analysis Set Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Full Analysis Set More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Full Analysis Set Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Full Analysis Set Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Full Analysis Set White | 22 Participants | 43 Participants | 21 Participants |
| Race (NIH/OMB) Per Protocol Set American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Per Protocol Set Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Per Protocol Set Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Per Protocol Set More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Per Protocol Set Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Per Protocol Set Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Per Protocol Set White | 18 Participants | 36 Participants | 18 Participants |
| Region of Enrollment Belgium | 7 participants | 14 participants | 7 participants |
| Region of Enrollment Israel | 1 participants | 1 participants | 0 participants |
| Region of Enrollment Switzerland | 16 participants | 32 participants | 16 participants |
| Sex: Female, Male Full Analysis Set Female | 8 Participants | 13 Participants | 5 Participants |
| Sex: Female, Male Full Analysis Set Male | 16 Participants | 34 Participants | 18 Participants |
| Sex: Female, Male Per Protocol Set Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Per Protocol Set Male | 15 Participants | 31 Participants | 16 Participants |
| STEMI: Thrombolysis in myocardial infarction (TIMI) risk score STEMI : TIMI Risk Score 3 or greater | 7 Participants | 14 Participants | 7 Participants |
| STEMI: Thrombolysis in myocardial infarction (TIMI) risk score STEMI : TIMI Risk Score less than 3 | 9 Participants | 15 Participants | 6 Participants |
| Time from onset of acute myocardial infarction symptoms to treatment start | 4.00 hours STANDARD_DEVIATION 1.64 | 3.93 hours STANDARD_DEVIATION 1.59 | 3.85 hours STANDARD_DEVIATION 1.56 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 23 |
| other Total, other adverse events | 12 / 24 | 7 / 23 |
| serious Total, serious adverse events | 1 / 24 | 1 / 23 |
Outcome results
Primary
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.
Time frame: 30 minutes after the administration of the subcutaneous injection
Population: The modified full analysis set (mFAS) includes all participants from the FAS who have an assessment of the primary endpoint (that is all participants with a 30-min post dose VerifyNow® blood sample analysis).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selatogrel 8 mg | Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | 21 Count of participants |
| Selatogrel 16 mg | Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | 21 Count of participants |
Comparison: The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.p-value: <0.001one-sided z-test
Comparison: The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.p-value: 0.142one-sided z-test
Comparison: The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.p-value: <0.0001one-sided z-test
Comparison: The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.p-value: 0.009one-sided z-test
Other Pre-specified
Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time
The pharmacodynamic response assessed by the inhibition of adenosine diphosphate (ADP)-mediated platelet aggregation was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test. The results are expressed as P2Y12 reaction units (PRU).
Time frame: pre-dose, 15, 30 and 60 minutes after administration of the subcutaneous injection
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Selatogrel 8 mg | Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time | pre-dose | 194 P2Y12 reaction units (PRU) |
| Selatogrel 8 mg | Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time | 15 minutes post-dose | 51 P2Y12 reaction units (PRU) |
| Selatogrel 8 mg | Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time | 30 minutes post-dose | 59 P2Y12 reaction units (PRU) |
| Selatogrel 8 mg | Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time | 60 minutes post-dose | 9 P2Y12 reaction units (PRU) |
| Selatogrel 16 mg | Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time | 60 minutes post-dose | 7 P2Y12 reaction units (PRU) |
| Selatogrel 16 mg | Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time | pre-dose | 181 P2Y12 reaction units (PRU) |
| Selatogrel 16 mg | Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time | 30 minutes post-dose | 9 P2Y12 reaction units (PRU) |
| Selatogrel 16 mg | Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time | 15 minutes post-dose | 9 P2Y12 reaction units (PRU) |
Other Pre-specified
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, 15, 30 and 60 minutes and 8 hours after the administration of the subcutaneous injection
Population: Pharmacokinetic analysis set - all participants that had at least one selatogrel concentration measurement after administration of study treatment.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Selatogrel 8 mg | Maximum Selatogrel Plasma Concentration (Cmax) | 390.1 ng/mL |
| Selatogrel 16 mg | Maximum Selatogrel Plasma Concentration (Cmax) | 672.6 ng/mL |
Other Pre-specified
Number of Participants (Per-protocol Subgroup) 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 at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response.
Time frame: 30 minutes after the administration of the subcutaneous injection
Population: Supportive analysis of the primary endpoint: per-protocol set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Selatogrel 8 mg | Number of Participants (Per-protocol Subgroup) With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | 18 Count of participants |
| Selatogrel 16 mg | Number of Participants (Per-protocol Subgroup) With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | 19 Count of participants |
Comparison: As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.p-value: 0.228One-sided Z-test
Comparison: As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.p-value: 0.0201One-sided Z-test
Other Pre-specified
Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation
The purpose of this supportive analysis was to assess the effect when relaxing the time of a PRU \< 100, i.e., considering as a response a PRU \< 100 at 15, 30 or 60 min. post injection. 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 post-dose was counted as a participant that had a pharmacodynamic response.
Time frame: pre-dose, 15, 30 and 60 minutes after the administration of the subcutaneous injection
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Selatogrel 8 mg | Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | pre-dose | 1 Count of participants |
| Selatogrel 8 mg | Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | 15 minutes post-dose | 18 Count of participants |
| Selatogrel 8 mg | Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | 30 minutes post-dose | 21 Count of participants |
| Selatogrel 8 mg | Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | 60 minutes post-dose | 18 Count of participants |
| Selatogrel 16 mg | Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | 60 minutes post-dose | 22 Count of participants |
| Selatogrel 16 mg | Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | pre-dose | 0 Count of participants |
| Selatogrel 16 mg | Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | 30 minutes post-dose | 21 Count of participants |
| Selatogrel 16 mg | Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | 15 minutes post-dose | 21 Count of participants |
Post Hoc
Subgroup Analyses: 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 at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response.
Time frame: 30 minutes after the administration of the subcutaneous injection
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Selatogrel 8 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Age less than 55 years old | 3 Count of participants |
| Selatogrel 8 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Age 55 years and older | 18 Count of participants |
| Selatogrel 8 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Male | 14 Count of participants |
| Selatogrel 8 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Female | 7 Count of participants |
| Selatogrel 8 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Body Mass Index less than 25 | 5 Count of participants |
| Selatogrel 8 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Body Mass Index less than 25 and up to 30 | 8 Count of participants |
| Selatogrel 8 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Body Mass Index greater than 30 | 8 Count of participants |
| Selatogrel 8 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Diabetes mellitus at baseline | 8 Count of participants |
| Selatogrel 8 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | No diabetes mellitus at baseline | 13 Count of participants |
| Selatogrel 8 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | No Chronic kidney disease at baseline | 21 Count of participants |
| Selatogrel 8 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | STEMI at baseline | 14 Count of participants |
| Selatogrel 8 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | NSTEMI at baseline | 7 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | STEMI at baseline | 11 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Body Mass Index greater than 30 | 4 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Age less than 55 years old | 4 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | No Chronic kidney disease at baseline | 18 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Age 55 years and older | 17 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Diabetes mellitus at baseline | 5 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Male | 17 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | NSTEMI at baseline | 10 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Female | 4 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | No diabetes mellitus at baseline | 16 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Body Mass Index less than 25 | 8 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Chronic kidney disease at baseline | 3 Count of participants |
| Selatogrel 16 mg | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Body Mass Index less than 25 and up to 30 | 9 Count of participants |
Other Pre-specified
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, 15, 30 and 60 minutes and 8 hours after the administration of the subcutaneous injection
Population: Pharmacokinetic analysis set - all participants that had at least one selatogrel concentration measurement after administration of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Selatogrel 8 mg | Time to Reach Maximum Selatogrel Plasma Concentration (Tmax) | 1.00 hours |
| Selatogrel 16 mg | Time to Reach Maximum Selatogrel Plasma Concentration (Tmax) | 0.97 hours |