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    Clinical Trial Results:
    A multi-center, open-label, randomized, study to assess the onset of platelet aggregation inhibition after a single subcutaneous injection of ACT-246475 in adults with acute myocardial infarction

    Summary
    EudraCT number
    2018-000765-36
    Trial protocol
    BE  
    Global end of trial date
    10 Nov 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Nov 2019
    First version publication date
    03 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ID-076A202
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03487445
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Idorsia Pharmaceuticals Ltd
    Sponsor organisation address
    ​Hegenheimermattweg 91, ​Allschwil, Switzerland, 4123
    Public contact
    Clinical Trial Disclosure Desk, Idorsia Pharmaceuticals Ltd, clinical-trials-disclosure@idorsia.com
    Scientific contact
    Clinical Trial Disclosure Desk, Idorsia Pharmaceuticals Ltd, clinical-trials-disclosure@idorsia.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess the inhibition of adenosine diposphate (ADP)-mediated platelet aggregation 30 min after a single subcutaneous (s.c.) injection of selatogrel (ACT-246475) in subjects with acute myocardial infarction (AMI) receiving conventional antithrombotic treatment (e.g., aspirin, chronic oral P2Y12 receptor antagonists, anticoagulants).
    Protection of trial subjects
    Prior to the start of the study, each study site consulted an independent ethics committee, i.e., a review panel that was responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation. The protocol and any material provided to the subject (such as a subject information sheet or description of the study used to obtain informed consent) were reviewed and approved by the appropriate Independent ethics committee before study was started. Eligible subjects presented with acute myocardial infarction (AMI; ST-segment elevation myocardial infarction [STEMI] or non-STEMI [NSTEMI]), a life-threatening condition, and therefore fulfilled the ICH-GCP definition of vulnerable subjects (“persons in emergency situations”). Accordingly, a specific process for obtaining consent was implemented in compliance with local regulations and approved by the independent ethics committee. An Independent Safety Event Committee had overall responsibility for safeguarding the interests of subjects.
    Background therapy
    Standard treatment of AMI was allowed including anticoagulants. Ticagrelor was the only oral P2Y12 receptor antagonist allowed to be initiated during the study and its administration was possible only after selatogrel administration. Use of fibrinolytics or GPIIb/IIIa inhibitors was prohibited unless required for bail-out. All other standard-of-care treatments for AMI were allowed without restriction.
    Evidence for comparator
    Not applicable.
    Actual start date of recruitment
    10 Jul 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Switzerland: 33
    Country: Number of subjects enrolled
    Belgium: 14
    Country: Number of subjects enrolled
    Israel: 1
    Worldwide total number of subjects
    48
    EEA total number of subjects
    14
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    18
    From 65 to 84 years
    29
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted between 10 July 2018 and 10 November 2018.

    Pre-assignment
    Screening details
    Of the 48 subjects screened and randomized, 47 subjects were treated. One subject randomized to the 8 mg selatogrel arm did not receive the study treatment for administrative reasons (study treatment in quarantine).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Selatogrel - 8mg
    Arm description
    A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous (s.c.) injection in the thigh.
    Arm type
    Experimental

    Investigational medicinal product name
    Selatogrel
    Investigational medicinal product code
    ACT-246475
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ACT-246475 for s.c. administration was supplied in sealed glass vials at a strength of 20 mg. The vials contained 22 mg of lyophilized ACT-246475A (hydrochloride salt of ACT-246475) for reconstitution with 1 mL of water for injection. The stock solution was diluted with 1 mL of NaCl 0.9% to obtain the required final concentration for injection ensuring the same volume of injection for both doses. The injected volume was 0.8 mL for all subjects. Administration was performed at the investigational site by qualified personnel.

    Arm title
    Selatogrel - 16 mg
    Arm description
    A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous (s.c.) injection in the thigh.
    Arm type
    Experimental

    Investigational medicinal product name
    Selatogrel
    Investigational medicinal product code
    ACT-246475
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ACT-246475 for s.c. administration was supplied in sealed glass vials at a strength of 20 mg. The vials contained 22 mg of lyophilized ACT-246475A (hydrochloride salt of ACT-246475) for reconstitution with 1 mL of water for injection. The injected volume was 0.8 mL for all subjects. Administration was performed at the investigational site by qualified personnel.

    Number of subjects in period 1
    Selatogrel - 8mg Selatogrel - 16 mg
    Started
    25
    23
    Completed
    24
    23
    Not completed
    1
    0
         Administrative reasons
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Selatogrel - 8mg
    Reporting group description
    A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous (s.c.) injection in the thigh.

    Reporting group title
    Selatogrel - 16 mg
    Reporting group description
    A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous (s.c.) injection in the thigh.

    Reporting group values
    Selatogrel - 8mg Selatogrel - 16 mg Total
    Number of subjects
    25 23 48
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    10 8 18
        From 65-84 years
    14 15 29
        85 years and over
    1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.3 ± 12.5 68.0 ± 10.3 -
    Gender categorical
    Units: Subjects
        Female
    8 5 13
        Male
    17 18 35
    Race
    Units: Subjects
        Asian
    1 2 3
        White
    23 21 44
        Other
    1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0 0 0
        Not Hispanic or Latino
    25 23 48
    Body mass index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    27.92 ± 4.75 26.78 ± 3.74 -

    End points

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    End points reporting groups
    Reporting group title
    Selatogrel - 8mg
    Reporting group description
    A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous (s.c.) injection in the thigh.

    Reporting group title
    Selatogrel - 16 mg
    Reporting group description
    A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous (s.c.) injection in the thigh.

    Primary: Number of subjects achieving a PD response

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    End point title
    Number of subjects achieving a PD response [1]
    End point description
    The primary PD endpoint was the response to treatment, defined for each subject as a P2Y12 reaction units (PRU) value < 100 at 30 min post-dose, as measured via the VerifyNow® assay. The PRU indicates the extent of (residual) ADP-mediated platelet aggregation, specific to the P2Y12 receptor.
    End point type
    Primary
    End point timeframe
    30 minutes post treatment administration
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: A statistical analysis comparing the two doses was not planned. The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose, i.e., 8 and 16 mg, at 0.025 type I error level, with null hypothesis defined as a proportion of responding patients less or equal to 50%. If this null hypothesis was rejected, a subsequent null hypothesis of treatment effect less or equal to 85% was tested at a 0.025 level.
    End point values
    Selatogrel - 8mg Selatogrel - 16 mg
    Number of subjects analysed
    23 [2]
    22 [3]
    Units: number of subjects
        Number of responders at 30 minutes
    21
    21
    Notes
    [2] - Modified full analysis set (all subjects with a 30-min post dose VerifyNow(R) blood sample analysis)
    [3] - Modified full analysis set (all subjects with a 30-min post dose VerifyNow(R) blood sample analysis)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events (TEAEs) were those adverse events with onset date/time after the date/time of study drug administration and up to 48 hours after the date/time of study treatment administration.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Selatogrel - 8 mg
    Reporting group description
    -

    Reporting group title
    Selatogrel - 16 mg
    Reporting group description
    -

    Serious adverse events
    Selatogrel - 8 mg Selatogrel - 16 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 23 (4.35%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Ventricular tachycardia
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Selatogrel - 8 mg Selatogrel - 16 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 24 (50.00%)
    7 / 23 (30.43%)
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Arteriovenous fistula
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Cardiac failure
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Extrasystoles
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Mitral valve stenosis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Nodal rhythm
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Ventricular tachycardia
         subjects affected / exposed
    3 / 24 (12.50%)
    2 / 23 (8.70%)
         occurrences all number
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Pleural effusion
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Confusional state
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Delirium
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    3 / 24 (12.50%)
    2 / 23 (8.70%)
         occurrences all number
    3
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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