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)

March 13, 2024 updated by: MicroPort CRM
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

Study Type

Interventional

Enrollment (Actual)

2248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • St Pölten, Austria
        • Universitätsklinikum
      • 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
        • Hôpital Jacques Cartier
      • Montpellier, France
        • CHU Montpellier
      • Montpellier, France
        • Clinique Millénaire
      • Nîmes, France
        • CHU Nimes
      • Reims, France
        • CHU Reims
      • Rouen, France
        • Clinique St Hilaire
      • Toulouse, France
        • Clinique Pasteur
      • Toulouse, France
        • CHU Toulouse
      • 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
      • 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
      • Lisbon, Portugal
        • Hospital Santa Maria
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shortened DAPT followed by P2Y12 inhibitor monotherapy
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
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)
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)
11 months post randomization
Bleeding events
Time Frame: 11 months post randomization
(Number of participants with first occurrence of) bleeding events (BARC 2,3 or 5)
11 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 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 (Estimated)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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