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Myocardial Infarction, AcuteTARGET-FIRSTNCT04753749

Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy

A study testing Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin) and Standard DAPT in people with Myocardial Infarction, Acute and Coronary Artery Disease, run by MicroPort CRM at 40 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study aims to evaluate a modified antiplatelet therapy associated with Firehawk low-dose rapamycin DES in acute myocardial infarction patients treated with complete revascularization strategy. The modified antiplatelet therapy consists of a reduced duration of Dual Antiplatelet Therapy post procedure (ie. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin) and Standard DAPT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,248 participants
Where
40 sitesin 6 countries
Study dates
25 Mar 2021to 5 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Troponin-positive Non-ST-Elevation MI, requiring early invasive treatment (PCI), or ST-Elevation MI requiring primary PCI, and PCI occurred within the last 7 days
  • Subject is eligible for per-protocol antiplatelet treatments
  • Written informed consent
  • Successful revascularization
  • All treated lesions:
  • In native coronary arteries only
Show all 11Show fewer
  • In vessels with visual reference diameter ≥2.25 mm and ≤ 4.00 mm
  • Implanted with the study device
  • Maximum 3 lesions treated (*)
  • Maximum total stent length ≤ 80 mm
  • Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 7 days from the index procedure.

Who cannot join

  • Subjects with prior STEMI or prior PCI within 12 months before index admission
  • Prior Coronary Artery Bypass Graft (CABG) Surgery
  • Cardiogenic shock
  • Secondary PCI
  • Fibrinolysis
  • Prior stent thrombosis
Show all 27Show fewer
  • Planned PCI, CABG, or surgery within 12 months
  • Need for Oral Anti-Coagulation therapy
  • Ischemic stroke or ICH within 12 months
  • eGFR <30 mL/min/1.73 m2 or dialysis
  • Active bleeding at time of inclusion or high risk for major bleeding
  • History of bleeding diathesis or coagulopathy or subject refuse blood transfusions
  • Stage B or C liver cirrhosis or active cancer within 12 months
  • Baseline haemoglobin <13 g/dL (12g/dL for women) or anaemia requiring transfusion in the 4 weeks prior to index procedure
  • Moderate or severe thrombocytopenia
  • Expected non-adherence to protocol or estimated life expectancy ≤12 months
  • Known hypersensitivity or contraindication to any medication used in the study or any of the study stent's components/compounds
  • Participation in another interventional clinical trial
  • Woman who is pregnant, nursing or with known intention to procreate
  • In-stent restenosis or thrombosis
  • Chronic total occlusion
  • Severe calcification
  • True bifurcation disease and side branch diameter ≥ 2mm, or bifurcation treated with 2 stents
  • Left main coronary artery lesion
  • Residual untreated dissection ≥ C
  • Implantation of a non-study stent
  • Subject is deemed to receive preferentially CABG within 1 year

Trial locations and contacts

40 sites in 6 countries.

40 sites in 6 countries

France20 sites

  • CHU Annecy

    Annecy

  • Clinique Roseraie

    Aubervilliers

  • CH Bastia

    Bastia

  • CHU Caen

    Caen

  • CH Chartres

    Chartres

  • CH Cherbourg

    Cherbourg

  • CHU Clermont-Ferrand

    Clermont-Ferrand

  • CHU Dijon

    Dijon

  • CH Haguenau

    Haguenau

  • CHU Lille

    Lille

  • CH St Joseph/St Luc

    Lyon

  • CHU La Timone

    Marseille

  • Hôpital Jacques Cartier

    Massy

  • CHU Montpellier

    Montpellier

  • Clinique Millénaire

    Montpellier

  • CHU Nîmes

    Nîmes

  • CHU Reims

    Reims

  • Clinique St Hilaire

    Rouen

  • CHU Toulouse

    Toulouse

  • Clinique Pasteur

    Toulouse

Other trials in France

Spain7 sites

  • Hospital General Universitario

    Alicante

  • Clinic Hospital Barcelona

    Barcelona

  • Hospital del Mar

    Barcelona

  • Puerta del mar

    Cadiz

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat

  • Hosp. Doctor Lucus Augusti

    Lugo

  • Hospital Universitario La Princesa

    Madrid

Other trials in Spain

Italy6 sites

  • Humanitas - Gavazzeni

    Bergamo

  • Clinica Montevergine

    Mercogliano

  • Niguarda

    Milan

  • AOU Federico II

    Naples

  • Policlinico Universitario

    Padova

  • Giovanni Paolo II

    Ragusa

Other trials in Italy

Netherlands5 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • Tergooi MC

    Blaricum

  • Albert Schweitzer Ziekenhuis

    Dordrecht

  • Maastad University Hospital

    Rotterdam

  • Haga Ziekenhuis

    The Hague

Other trials in Netherlands

Austria1 site

  • Universitätsklinikum

    Sankt Pölten

Other trials in Austria

Portugal1 site

  • Hospital Santa Maria

    Lisbon

Other trials in Portugal

About this study

The study aims to evaluate a modified antiplatelet therapy associated with Firehawk low-dose rapamycin DES in acute myocardial infarction patients treated with complete revascularization strategy. The modified antiplatelet therapy consists of a reduced duration of Dual Antiplatelet Therapy post procedure (ie. 1 month duration) followed by P2Y12 inhibitor monotherapy for the next 11 months. It is hypothesized that in the setting of clinically stable, low to moderate complexity acute Myocardial Infarction patients, a modern approach combining a stent with high biocompatibility feature, complete revascularization strategy and modified antiplatelet therapy may be associated with similar outcomes, or even a significant benefit compared with guidelines-recommended 12-month DAPT. This benefit could be driven by a reduced risk in significant bleeding events, while keeping a comparable protection against ischemic risk. Enrolled subjects will be randomized in a 1:1 ratio to either cessation of aspirin at 1 months, either continuation of DAPT. Selection of the P2Y12 inhibitor agent is left to investigator judgment but has to be in line with the current ESC guidelines. Subjects treated with the Firehawk or Firehawk Liberty coronary stent will be included in this study.

Being tested
Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin), Standard DAPT
Medical subject headings
Myocardial Infarction, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin)Drug

    Subjects will receive DAPT during 1 month post procedure, followed by P2Y12 inhibitor monotherapy (cessation of aspirin) for the next 11 months

  • Standard DAPTDrug

    Subjects will receive standard treatment: P2Y12 inhibitor and aspirin (DAPT) during 12 months after procedure

Study groups in NCT04753749
Study groupRoleWhat they receive
Shortened DAPT followed by P2Y12 inhibitor monotherapyExperimentalNot described
Receives: Drug: Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin)
Dual Antiplatelet TherapyActive comparatorNot described
Receives: Drug: Standard DAPT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Net Adverse Clinical and Cerebral Events (NACCE)

    (Number of participants with first occurrence of) NACCE, defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or bleeding events (BARC type 3 or 5)

    Measured: 11 months post randomization

Secondary outcomes (25)

  1. Bleeding events

    (Number of participants with first occurrence of) bleeding events (BARC 2,3 or 5)

    Measured: 11 months post randomization

  2. All-cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, or stroke

    (Number of participants with first occurrence of) all-cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, or stroke

    Measured: At 1 month, 6 months and 12 months

  3. Primary endpoint component 5 - BARC 3 and 5 bleeding events

    (Number of participants with first occurrence of) BARC 3 and 5 bleeding events

    Measured: At 1 month, 6 months and 12 months

  4. All-cause death or non-fatal myocardial infarction

    (Number of patients with first occurrence of) all-cause death or non-fatal myocardial infarction

    Measured: At 1 month, 6 months and 12 months

  5. Major Adverse Cardiac and Cerebral Events (MACCE) - Patient

    Patient-oriented composite of major adverse cardiac and cerebral events (MACCE) including all-cause death, myocardial infarction, definite/probable stent thrombosis, any stroke, any Ischemia driven repeat revascularization, or BARC bleeding events (type 2, 3, or 5)

    Measured: At 1 month, 6 months and 12 months

  6. Target Lesion Failure - Device

    Device oriented composite endpoint of Target Lesion Failure (cardiac death, target vessel related myocardial infarction, target lesion Ischemia Driven-revascularization)

    Measured: At 1 month, 6 months and 12 months

  7. Major Adverse Cardiac and Cerebral events (MACE) - Events

    Number of Major Adverse Cardiac and Cerebral events (MACE)

    Measured: At 1 Month, 6 months and 12 months

  8. Primary endpoint component 3 - Stent thrombosis

    Definite or probable stent thrombosis

    Measured: At 1 months, 6 months and 12 months

  9. Main secondary endpoint component 2 - BARC 3 events

    (Number of patients with occurrence of) BARC 3 events

    Measured: At 1 month, 6 months and 12 months

  10. Main secondary endpoint component 3 - BARC 5 events

    (Number of patients with occurrence of) BARC 5 events

    Measured: At 1 month, 6 months and 12 months

  11. Main secondary endpoint component 1 - BARC 2 events

    (Number of patients with occurrence of) BARC 2 events

    Measured: At 1 month, 6 months and 12 months

  12. Cardiovascular death

    Number of patients with cardiovascular death

    Measured: At 1 months, 6 months and 12 months

  13. Cardiac death

    Number of patients with cardiac death

    Measured: At 1 month, 6 months and 12 months

  14. Non cardiac death

    Number of patients with non cardiac death

    Measured: At 1 month, 6 months and 12 months

  15. Primary endpoint component 2 - Myocardial infarction

    Number of patients with myocardial infarction

    Measured: At 1 month, 6 months and 12 months

  16. Cardiac death or non-fatal myocardial infarction

    (Number of patients with first occurrence of) cardiac death or non-fatal myocardial infarction

    Measured: At 1 month, 6 months and 12 months

  17. Cardiac death, myocardial infarction, or definite/probable stent thrombosis

    (Number of patients with first occurrence of) cardiac death, myocardial infarction, or definite/probable stent thrombosis

    Measured: At 1 month, 6 months and 12 months

  18. Cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke

    (Number of patients with first occurrence of) cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke

    Measured: 1 month, 6 months and 12 months

  19. Primary endpoint component 4 - Ischemic stroke

    (Number of patients with occurrence of) ischemic stroke

    Measured: At 1 month, 6 months and 12 months

  20. Haemorrhagic stroke

    (Number of patients with occurrence of) haemorrhagic stroke

    Measured: At 1 month, 6 months and 12 months

  21. Ischemia-driven target lesion revascularization

    (Number of patients with) Ischemia-driven target lesion revascularization

    Measured: At 1 month, 6 months and 12 months

  22. Ischemia-driven target vessel revascularization

    (Number of patients with) Ischemia-driven target vessel revascularization

    Measured: At 1 month, 6 months and 12 months

  23. Cardiovascular death, myocardial infarction, or ischemic stroke

    (Number of patients with first occurrence of) cardiovascular death, myocardial infarction, or ischemic stroke

    Measured: At 1 month, 6 months and 12 months

  24. Primary endpoint component 1 - All cause death

    (Number of patients with) all cause death

    Measured: At 1 month, 6 months and 12 months

  25. Primary endpoint component 2 - Myocardial infarction

    (Number of patients with occurrence of) myocardial infarction

    Measured: At 1 month, 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2021
  2. Study start25 Mar 2021
  3. Primary completion5 May 2025
  4. Study completion5 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04753749
Sponsor's protocol ID
SFHI01
Acronym
TARGET-FIRST
Status last verified
May 2025
First submitted
8 Feb 2021
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tarantini G, Smits PC, Lhermusier T, Honton B, Range G, Piot C, Lemesle G, Ruiz Nodar JM, Godin M, Madera Cambero M, Motreff P, Cuisset T, Bouchez D, Poezevara Y, Cayla G. A prospective study comparing short versus standard dual antiplatelet therapy in patients with acute myocardial infarction: design and rationale of the TARGET-FIRST trial. EuroIntervention. 2023 Jun 19;19(3):240-247. doi: 10.4244/EIJ-D-22-01006.

    PubMed 36999409

  • Tarantini G, Honton B, Paradies V, Lemesle G, Range G, Godin M, Mangin L, Cuisset T, Ruiz-Nodar JM, Brugaletta S, Lhermusier T, Piot C, De Poli F, Macia JC, Motreff P, Madera-Cambero M, Beygui F, Riccini P, Ranc S, Oreglia JA, Vaquerizo B, Poezevara Y, Bouchez D, Smits PC, Cayla G; TARGET-FIRST Investigators. Early Discontinuation of Aspirin after PCI in Low-Risk Acute Myocardial Infarction. N Engl J Med. 2025 Nov 27;393(21):2083-2094. doi: 10.1056/NEJMoa2508808. Epub 2025 Aug 31.

    PubMed 40888726

Questions about this trial

What is this clinical trial studying?

A study testing Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin) and Standard DAPT in people with Myocardial Infarction, Acute and Coronary Artery Disease, run by MicroPort CRM at 40 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in France, Spain, Italy, Netherlands, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net Adverse Clinical and Cerebral Events (NACCE) (time frame: 11 months post randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04753749, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.

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