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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Myocardial Infarction, Acute
• Intervention / Treatment: Drug: Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin); Drug: Standard DAPT

• Study Type: Interventional
• Enrollment (Actual): 2248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • St Pölten, Austria
    • Universitätsklinikum
• France
  • Annecy, France
    • CHU Annecy
  • Aubervilliers, France
    • Clinique Roseraie
  • Bastia, France
    • CH Bastia
  • Caen, France
    • CHU caen
  • Chartres, France
    • CH Chartres
  • Cherbourg, France
    • CH Cherbourg
  • Clermont-Ferrand, France
    • Chu Clermont-Ferrand
  • Dijon, France
    • CHU Dijon
  • Haguenau, France
    • CH Haguenau
  • Lille, France
    • Chu Lille
  • Lyon, France
    • CH St Joseph/St Luc
  • Marseille, France
    • CHU La Timone
  • Massy, France
    • Hopital Jacques Cartier
  • Montpellier, France
    • CHU Montpellier
  • Montpellier, France
    • Clinique Millenaire
  • Nîmes, France
    • CHU Nimes
  • Reims, France
    • Chu Reims
  • Rouen, France
    • Clinique St Hilaire
  • Toulouse, France
    • Clinique Pasteur
  • Toulouse, France
    • CHU Toulouse
• Italy
  • Bergamo, Italy
    • Humanitas - Gavazzeni
  • Mercogliano, Italy
    • Clinica Montevergine
  • Milan, Italy
    • Niguarda
  • Napoli, Italy
    • AOU Federico II
  • Padova, Italy
    • Policlinico Universitario
  • Ragusa, Italy
    • Giovanni Paolo II
• Netherlands
  • Blaricum, Netherlands
    • Tergooi Mc
  • Den Bosch, Netherlands
    • Jeroen Bosch Ziekenhuis
  • Dordrecht, Netherlands
    • Albert Schweitzer Ziekenhuis
  • Rotterdam, Netherlands
    • Maastad University Hospital
  • The Hague, Netherlands
    • Haga ziekenhuis
• Portugal
  • Lisbon, Portugal
    • Hospital Santa Maria
• Spain
  • Alicante, Spain
    • Hospital General Universitario
  • Barcelona, Spain
    • Hospital Del Mar
  • Barcelona, Spain
    • Clinic Hospital Barcelona
  • Cadiz, Spain
    • Puerta del mar
  • L'Hospitalet De Llobregat, Spain
    • Hospital Universitario de Bellvitge
  • Lugo, Spain
    • Hosp. Doctor Lucus Augusti
  • Madrid, Spain
    • Hospital Universitario La Princesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shortened DAPT followed by P2Y12 inhibitor monotherapy	Drug: Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin); Subjects will receive DAPT during 1 month post procedure, followed by P2Y12 inhibitor monotherapy (cessation of aspirin) for the next 11 months
Active Comparator: Dual Antiplatelet Therapy	Drug: Standard DAPT; Subjects will receive standard treatment: P2Y12 inhibitor and aspirin (DAPT) during 12 months after procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	11 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding events	(Number of participants with first occurrence of) bleeding events (BARC 2,3 or 5)	11 months post randomization
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	At 1 month, 6 months and 12 months
Primary endpoint component 5 - BARC 3 and 5 bleeding events	(Number of participants with first occurrence of) BARC 3 and 5 bleeding events	At 1 month, 6 months and 12 months
All-cause death or non-fatal myocardial infarction	(Number of patients with first occurrence of) all-cause death or non-fatal myocardial infarction	At 1 month, 6 months and 12 months
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)	At 1 month, 6 months and 12 months
Target Lesion Failure - Device	Device oriented composite endpoint of Target Lesion Failure (cardiac death, target vessel related myocardial infarction, target lesion Ischemia Driven-revascularization)	At 1 month, 6 months and 12 months
Major Adverse Cardiac and Cerebral events (MACE) - Events	Number of Major Adverse Cardiac and Cerebral events (MACE)	At 1 Month, 6 months and 12 months
Primary endpoint component 3 - Stent thrombosis	Definite or probable stent thrombosis	At 1 months, 6 months and 12 months
Main secondary endpoint component 2 - BARC 3 events	(Number of patients with occurrence of) BARC 3 events	At 1 month, 6 months and 12 months
Main secondary endpoint component 3 - BARC 5 events	(Number of patients with occurrence of) BARC 5 events	At 1 month, 6 months and 12 months
Main secondary endpoint component 1 - BARC 2 events	(Number of patients with occurrence of) BARC 2 events	At 1 month, 6 months and 12 months
Cardiovascular death	Number of patients with cardiovascular death	At 1 months, 6 months and 12 months
Cardiac death	Number of patients with cardiac death	At 1 month, 6 months and 12 months
Non cardiac death	Number of patients with non cardiac death	At 1 month, 6 months and 12 months
Primary endpoint component 2 - Myocardial infarction	Number of patients with myocardial infarction	At 1 month, 6 months and 12 months
Cardiac death or non-fatal myocardial infarction	(Number of patients with first occurrence of) cardiac death or non-fatal myocardial infarction	At 1 month, 6 months and 12 months
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	At 1 month, 6 months and 12 months
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	1 month, 6 months and 12 months
Primary endpoint component 4 - Ischemic stroke	(Number of patients with occurrence of) ischemic stroke	At 1 month, 6 months and 12 months
Haemorrhagic stroke	(Number of patients with occurrence of) haemorrhagic stroke	At 1 month, 6 months and 12 months
Ischemia-driven target lesion revascularization	(Number of patients with) Ischemia-driven target lesion revascularization	At 1 month, 6 months and 12 months
Ischemia-driven target vessel revascularization	(Number of patients with) Ischemia-driven target vessel revascularization	At 1 month, 6 months and 12 months
Cardiovascular death, myocardial infarction, or ischemic stroke	(Number of patients with first occurrence of) cardiovascular death, myocardial infarction, or ischemic stroke	At 1 month, 6 months and 12 months
Primary endpoint component 1 - All cause death	(Number of patients with) all cause death	At 1 month, 6 months and 12 months
Primary endpoint component 2 - Myocardial infarction	(Number of patients with occurrence of) myocardial infarction	At 1 month, 6 months and 12 months

Collaborators and Investigators

• Sponsor: MicroPort CRM
• Collaborators: European Cardiovascular Research Center
• Investigators: Principal Investigator: Giuseppe Tarantini, Pr, Padova University Hospital, Italy; Study Director: Cayla Guillaume, Pr, Nîmes University Hospital, France; Study Director: Smits Peter, Pr, Maastad University Hospital, Netherlands

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Actual): May 5, 2025
• Study Completion (Actual): May 5, 2025

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Ischemia; Coronary Artery Disease; Myocardial Infarction; Infarction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Aspirin
• Other Study ID Numbers: SFHI01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No