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    Clinical Trial Results:
    Evaluation of a modified Anti-Platelet Therapy associated with low-dose rapamycin DES Firehawk in Acute Myocardial Infarction Patients treated with complete revascularization strategy (TARGET-FIRST)

    Summary
    EudraCT number
    		 2020-005933-34
    Trial protocol
    		 AT   NL   ES   IT   PT  
    Global end of trial date
    24 Mar 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2026
    First version publication date
    27 Mar 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SFHI01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04753749
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    SORIN CRM SAS (Microport)
    Sponsor organisation address
    4 avenue reaumur, Clamart, France, 92140
    Public contact
    Clinical Affairs, Sorin CRM SAS (Microport CRM), +33 0146013409, yann.poezevara@crm.microport.com
    Scientific contact
    Clinical Affairs, Sorin CRM SAS (Microport CRM), 0607526971 0146013409, yann.poezevara@crm.microport.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
    15 Jan 2026
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Mar 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate a modified Anti-Platelet Therapy, associated with low-dose rapamycin DES Firehawk in Acute Myocardial Infarction Patients treated with complete revascularization strategy, in reaching non-inferior NACE (among clinically stable, low to moderate complexity acute MI patients).
    Protection of trial subjects
    Pre-specified stopping rules
    Background therapy
    		 Percutaneous Coronary Intervention in the setting of Acute Myocardial Infarction
    Evidence for comparator
    		 Comparator is dual-antiplatelet (standard of care) for 12 months after PCI
    Actual start date of recruitment
    15 Mar 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 300
    Country: Number of subjects enrolled
    Italy: 148
    Country: Number of subjects enrolled
    France: 1525
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Austria: 23
    Country: Number of subjects enrolled
    Spain: 249
    Worldwide total number of subjects
    2246
    EEA total number of subjects
    2246
    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)
    1384
    From 65 to 84 years
    831
    85 years and over
    31

    Subject disposition

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    Recruitment
    Recruitment details
    		 First Patient First Visit (Enroll. / Random.) 25/03/2021 ( 27/04/2021) Last Patient First Visit (Enroll. / Random.) 06/03/2024 (15/04/2024) Last Patient Last Visit 24/03/2025

    Pre-assignment
    Screening details
    		 Patients were eligible for randomization if successful PCI without complication, and compliant to DAPT treatment until randomizatio visit

    Pre-assignment period milestones
    Number of subjects started
    		 2246
    Number of subjects completed
    		 2246

    Period 1
    Period 1 title
    Pre-randomization
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 overall
    Arm description
    		 1 month period after enrollment, until randomization
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Efient
    Investigational medicinal product code
    PRD9985304
    Other name
    Prasugrel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg daily

    Investigational medicinal product name
    Plavix
    Investigational medicinal product code
    PRD2912277
    Other name
    Clopidogrel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg daily

    Investigational medicinal product name
    Brilique
    Investigational medicinal product code
    PRD3534050
    Other name
    Ticagrelor
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90 mg twice daily

    Investigational medicinal product name
    ASPIRINE PROTECT
    Investigational medicinal product code
    PRD855688
    Other name
    Aspirin
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg daily

    Number of subjects in period 1
    		overall
    Started
    2246
    Completed
    1942
    Not completed
    304
         non-eligible
    304
    Period 2
    Period 2 title
    Randomization
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 P2Y12 inhibitor Monotherapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Efient
    Investigational medicinal product code
    PRD9985304
    Other name
    Prasugrel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg daily

    Investigational medicinal product name
    Plavix
    Investigational medicinal product code
    PRD2912277
    Other name
    Clopidogrel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg daily

    Investigational medicinal product name
    Brilique
    Investigational medicinal product code
    PRD3534050
    Other name
    Ticagrelor
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90 mg twice daily

    Arm title
    		 Control
    Arm description
    		 DAPT
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Efient
    Investigational medicinal product code
    PRD9985304
    Other name
    Prasugrel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg daily

    Investigational medicinal product name
    Plavix
    Investigational medicinal product code
    PRD2912277
    Other name
    Clopidogrel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg daily

    Investigational medicinal product name
    Brilique
    Investigational medicinal product code
    PRD3534050
    Other name
    Ticagrelor
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90 mg twice daily

    Investigational medicinal product name
    ASPIRINE PROTECT
    Investigational medicinal product code
    PRD855688
    Other name
    Aspirin
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg daily

    Number of subjects in period 2
    		Intervention Control
    Started
    961
    981
    Completed
    961
    981

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pre-randomization
    Reporting group description
    		 -

    Reporting group values
    		 Pre-randomization Total
    Number of subjects
    		 2246 2246
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1384 1384
        From 65-84 years
    		 831 831
        85 years and over
    		 31 31
    Gender categorical
    Units: Subjects
        Female
    		 500 500
        Male
    		 1746 1746

    End points

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    End points reporting groups
    Reporting group title
    overall
    Reporting group description
    		 1 month period after enrollment, until randomization
    Reporting group title
    Intervention
    Reporting group description
    		 P2Y12 inhibitor Monotherapy

    Reporting group title
    Control
    Reporting group description
    		 DAPT

    Primary: Net Adverse Clinical and Cerebrovascular Events (NACCE)

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    End point title
    		 Net Adverse Clinical and Cerebrovascular Events (NACCE) [1]
    End point description
    NACCE is defined as the composite of all cause death, myocardial infarction, definite/probable study stent thrombosis, stroke, or BARC bleeding (type 3 or 5), at 11 months after randomization (334 days from randomization).
    End point type
    Primary
    End point timeframe
    11 months post-randomization
    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: Study results uploaded in CTIS (transition trial)
    End point values
    		 Intervention Control
    Number of subjects analysed
    961
    981
    Units: Events
    20
    21
    No statistical analyses for this end point

    Secondary: Bleeding events

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    End point title
    		 Bleeding events
    End point description
    Bleeding events defined as BARC type 2, 3 or 5
    End point type
    Secondary
    End point timeframe
    11 months post-randomization
    End point values
    		 Intervention Control
    Number of subjects analysed
    961
    981
    Units: Events
    25
    54
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 3%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Annual Safety Reports (ASR) were sent yearly to ANSM, AGEs, AIFA, AEMPS, CCMO and INFARMED.as well as all the ECs. From 2023, Development Safety Update Report (DSUR) was sent to Italian authorities and it was published on CTIS in 2025. No SUSAR in relation to the antiplatelet therapy was reported. No USADE related to the to stent was neither reported. Final study report posted on CTIS (transitioned trial)

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/40888726
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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