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Completed

NCT Number: NCT04753749

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

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.

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Key information

Conditions

Myocardial Infarction, Acute Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum, Sankt Pölten, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(General):

  • 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

Inclusion criteria

(Procedural/angiographic):

  • Successful revascularization
  • All treated lesions:
  • In native coronary arteries only
  • 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.

Exclusion criteria

(General):

  • 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
  • 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

Exclusion criteria

(Procedural/Angiographic):

  • 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

Treatment and study plan

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 DAPT

Drug

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

Primary outcomes

  1. Net Adverse Clinical and Cerebral Events (NACCE)

    Time frame: 11 months post randomization

    (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)

Secondary outcomes

  1. Bleeding events

    Time frame: 11 months post randomization

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

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

    Time frame: At 1 month, 6 months and 12 months

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

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

    Time frame: At 1 month, 6 months and 12 months

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

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

    Time frame: At 1 month, 6 months and 12 months

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

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

    Time frame: At 1 month, 6 months and 12 months

    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)

  6. Target Lesion Failure - Device

    Time frame: At 1 month, 6 months and 12 months

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

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

    Time frame: At 1 Month, 6 months and 12 months

    Number of Major Adverse Cardiac and Cerebral events (MACE)

  8. Primary endpoint component 3 - Stent thrombosis

    Time frame: At 1 months, 6 months and 12 months

    Definite or probable stent thrombosis

  9. Main secondary endpoint component 2 - BARC 3 events

    Time frame: At 1 month, 6 months and 12 months

    (Number of patients with occurrence of) BARC 3 events

  10. Main secondary endpoint component 3 - BARC 5 events

    Time frame: At 1 month, 6 months and 12 months

    (Number of patients with occurrence of) BARC 5 events

  11. Main secondary endpoint component 1 - BARC 2 events

    Time frame: At 1 month, 6 months and 12 months

    (Number of patients with occurrence of) BARC 2 events

  12. Cardiovascular death

    Time frame: At 1 months, 6 months and 12 months

    Number of patients with cardiovascular death

  13. Cardiac death

    Time frame: At 1 month, 6 months and 12 months

    Number of patients with cardiac death

  14. Non cardiac death

    Time frame: At 1 month, 6 months and 12 months

    Number of patients with non cardiac death

  15. Primary endpoint component 2 - Myocardial infarction

    Time frame: At 1 month, 6 months and 12 months

    Number of patients with myocardial infarction

  16. Cardiac death or non-fatal myocardial infarction

    Time frame: At 1 month, 6 months and 12 months

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

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

    Time frame: At 1 month, 6 months and 12 months

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

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

    Time frame: 1 month, 6 months and 12 months

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

  19. Primary endpoint component 4 - Ischemic stroke

    Time frame: At 1 month, 6 months and 12 months

    (Number of patients with occurrence of) ischemic stroke

  20. Haemorrhagic stroke

    Time frame: At 1 month, 6 months and 12 months

    (Number of patients with occurrence of) haemorrhagic stroke

  21. Ischemia-driven target lesion revascularization

    Time frame: At 1 month, 6 months and 12 months

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

  22. Ischemia-driven target vessel revascularization

    Time frame: At 1 month, 6 months and 12 months

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

  23. Cardiovascular death, myocardial infarction, or ischemic stroke

    Time frame: At 1 month, 6 months and 12 months

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

  24. Primary endpoint component 1 - All cause death

    Time frame: At 1 month, 6 months and 12 months

    (Number of patients with) all cause death

  25. Primary endpoint component 2 - Myocardial infarction

    Time frame: At 1 month, 6 months and 12 months

    (Number of patients with occurrence of) myocardial infarction

Sponsors and collaborators

Lead sponsor

MicroPort CRM

Industry

Collaborators

  • European Cardiovascular Research Center

Registry information

Acronym: TARGET-FIRST

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2021
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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