Trial · NCT03487445
A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack
NCT03487445, Phase 2, Completed, Viatris Innovation GmbH; results first posted 2021-08-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack. Trials, record NCT03487445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03487445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack
- NCT number
- NCT03487445
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Viatris Innovation GmbH
- Conditions
- Acute Myocardial Infarction
- Interventions
- Selatogrel 8 mg, Selatogrel 16 mg
- First posted
- 2018-04-04
- Last updated
- 2026-07-29
- Other registries' IDs
- eudract:2018-000765-36
- Results first posted
- 2021-08-25
- 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.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Other | 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 | 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. |
| Other | 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 | 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. |
| Other | Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time | pre-dose, 15, 30 and 60 minutes after administration of the subcutaneous injection | 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). |
| Other | Maximum Selatogrel Plasma Concentration (Cmax) | pre-dose, 15, 30 and 60 minutes and 8 hours after the administration of the subcutaneous injection | 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. |
| Other | Time to Reach Maximum Selatogrel Plasma Concentration (Tmax) | pre-dose, 15, 30 and 60 minutes and 8 hours after the administration of the subcutaneous injection | Time after subcutaneous injection to reach the maximum observed selatogrel plasma concentration (Cmax). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 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). | Count of participants | NUMBER |
| OTHER_PRE_SPECIFIED | 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 | Supportive analysis of the primary endpoint: per-protocol set | Count of participants | NUMBER |
| OTHER_PRE_SPECIFIED | 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 | Full analysis set | Count of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time | pre-dose, 15, 30 and 60 minutes after administration of the subcutaneous injection | Full Analysis Set | P2Y12 reaction units (PRU) | MEDIAN |
| OTHER_PRE_SPECIFIED | Maximum Selatogrel Plasma Concentration (Cmax) | pre-dose, 15, 30 and 60 minutes and 8 hours after the administration of the subcutaneous injection | Pharmacokinetic analysis set - all participants that had at least one selatogrel concentration measurement after administration of study treatment. | ng/mL | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Time to Reach Maximum Selatogrel Plasma Concentration (Tmax) | pre-dose, 15, 30 and 60 minutes and 8 hours after the administration of the subcutaneous injection | Pharmacokinetic analysis set - all participants that had at least one selatogrel concentration measurement after administration of study treatment. | hours | MEDIAN |
| POST_HOC | Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | 30 minutes after the administration of the subcutaneous injection | Full Analysis Set | Count of participants | NUMBER |
Source ClinicalTrials.gov
Results by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Selatogrel 8 mg | 21 | Count of participants | ||
| Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Selatogrel 16 mg | 21 | Count of participants | ||
| Number of Participants (Per-protocol Subgroup) With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Selatogrel 8 mg | 18 | Count of participants | ||
| Number of Participants (Per-protocol Subgroup) With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation | Selatogrel 16 mg | 19 | Count of participants | ||
| Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | Selatogrel 8 mg | pre-dose | 1 | Count of participants | |
| Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | Selatogrel 16 mg | pre-dose | 0 | Count of participants | |
| Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | Selatogrel 8 mg | 15 minutes post-dose | 18 | Count of participants | |
| Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | Selatogrel 16 mg | 15 minutes post-dose | 21 | Count of participants | |
| Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | Selatogrel 8 mg | 30 minutes post-dose | 21 | Count of participants | |
| Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation | Selatogrel 16 mg | 30 minutes post-dose | 21 | Count of participants |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization | STARTED | Selatogrel 8 mg | 25 | |
| Randomization | STARTED | Selatogrel 16 mg | 23 | |
| Randomization | COMPLETED | Selatogrel 8 mg | 24 | |
| Randomization | COMPLETED | Selatogrel 16 mg | 23 | |
| Randomization | NOT COMPLETED | Selatogrel 8 mg | 1 | |
| Randomization | NOT COMPLETED | Selatogrel 16 mg | 0 | |
| Treatment Period | STARTED | Selatogrel 8 mg | 24 | |
| Treatment Period | STARTED | Selatogrel 16 mg | 23 | |
| Treatment Period | Modified Full Analysis Set (mFAS) | Selatogrel 8 mg | 23 | |
| Treatment Period | Modified Full Analysis Set (mFAS) | Selatogrel 16 mg | 22 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Aortic stenosis | Vascular disorders | Selatogrel 8 mg | 0 | 24 | 0 |
| other | Aortic stenosis | Vascular disorders | Selatogrel 16 mg | 1 | 23 | 1 |
| other | Arteriovenous fistula | Vascular disorders | Selatogrel 8 mg | 1 | 24 | 1 |
| other | Arteriovenous fistula | Vascular disorders | Selatogrel 16 mg | 0 | 23 | 0 |
| other | Hypertension | Vascular disorders | Selatogrel 8 mg | 1 | 24 | 1 |
| other | Hypertension | Vascular disorders | Selatogrel 16 mg | 0 | 23 | 0 |
| other | Hypotension | Vascular disorders | Selatogrel 8 mg | 1 | 24 | 1 |
| other | Hypotension | Vascular disorders | Selatogrel 16 mg | 0 | 23 | 0 |
| other | Post procedural haemorrhage | Injury, poisoning and procedural complications | Selatogrel 8 mg | 1 | 24 | 1 |
| other | Post procedural haemorrhage | Injury, poisoning and procedural complications | Selatogrel 16 mg | 0 | 23 | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selatogrel 8 mg | 0 | 24 |
| Total, all-cause mortality | Selatogrel 16 mg | 0 | 23 |
| Total, other adverse events | Selatogrel 8 mg | 12 | 24 |
| Total, other adverse events | Selatogrel 16 mg | 7 | 23 |
| Total, serious adverse events | Selatogrel 8 mg | 1 | 24 |
| Total, serious adverse events | Selatogrel 16 mg | 1 | 23 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Selatogrel 8 mg vs Selatogrel 16 mg: deaths from any cause | Trial comparisons |
| Selatogrel 8 mg vs Selatogrel 16 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03487445
GET https://conductscience.org/api/trials/v1/NCT03487445/results?page=2