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)

July 25, 2025 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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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
        • Hôpital 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
At 1 month, 6 months and 12 months
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
At 1 month, 6 months and 12 months
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
At 1 month, 6 months and 12 months
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)
At 1 month, 6 months and 12 months
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)
At 1 month, 6 months and 12 months
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)
At 1 Month, 6 months and 12 months
Primary endpoint component 3 - Stent thrombosis
Time Frame: At 1 months, 6 months and 12 months
Definite or probable stent thrombosis
At 1 months, 6 months and 12 months
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
At 1 month, 6 months and 12 months
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
At 1 month, 6 months and 12 months
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
At 1 month, 6 months and 12 months
Cardiovascular death
Time Frame: At 1 months, 6 months and 12 months
Number of patients with cardiovascular death
At 1 months, 6 months and 12 months
Cardiac death
Time Frame: At 1 month, 6 months and 12 months
Number of patients with cardiac death
At 1 month, 6 months and 12 months
Non cardiac death
Time Frame: At 1 month, 6 months and 12 months
Number of patients with non cardiac death
At 1 month, 6 months and 12 months
Primary endpoint component 2 - Myocardial infarction
Time Frame: At 1 month, 6 months and 12 months
Number of patients with myocardial infarction
At 1 month, 6 months and 12 months
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
At 1 month, 6 months and 12 months
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
At 1 month, 6 months and 12 months
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
1 month, 6 months and 12 months
Primary endpoint component 4 - Ischemic stroke
Time Frame: At 1 month, 6 months and 12 months
(Number of patients with occurrence of) ischemic stroke
At 1 month, 6 months and 12 months
Haemorrhagic stroke
Time Frame: At 1 month, 6 months and 12 months
(Number of patients with occurrence of) haemorrhagic stroke
At 1 month, 6 months and 12 months
Ischemia-driven target lesion revascularization
Time Frame: At 1 month, 6 months and 12 months
(Number of patients with) Ischemia-driven target lesion revascularization
At 1 month, 6 months and 12 months
Ischemia-driven target vessel revascularization
Time Frame: At 1 month, 6 months and 12 months
(Number of patients with) Ischemia-driven target vessel revascularization
At 1 month, 6 months and 12 months
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
At 1 month, 6 months and 12 months
Primary endpoint component 1 - All cause death
Time Frame: At 1 month, 6 months and 12 months
(Number of patients with) all cause death
At 1 month, 6 months and 12 months
Primary endpoint component 2 - Myocardial infarction
Time Frame: At 1 month, 6 months and 12 months
(Number of patients with occurrence of) myocardial infarction
At 1 month, 6 months and 12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MicroPort CRM

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Cardiovascular Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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