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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)

Primary Purpose

Myocardial Infarction, Acute, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin)
Standard DAPT
Sponsored by
MicroPort CRM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UniversitätsklinikumRecruiting
  • CHU AnnecyRecruiting
  • Clinique RoseraieRecruiting
  • CH BastiaRecruiting
  • CHU CaenRecruiting
  • CH ChartresRecruiting
  • CH CherbourgRecruiting
  • CHU Clermont-FerrandRecruiting
  • CHU DijonRecruiting
  • CH HaguenauRecruiting
  • CHU LilleRecruiting
  • CH St Joseph/St LucRecruiting
  • CHU La TimoneRecruiting
  • Hôpital Jacques CartierRecruiting
  • CHU MontpellierRecruiting
  • Clinique MillénaireRecruiting
  • CHU NîmesRecruiting
  • CHU ReimsRecruiting
  • Clinique St HilaireRecruiting
  • CHU ToulouseRecruiting
  • Clinique PasteurRecruiting
  • Humanitas - GavazzeniRecruiting
  • Clinica Montevergine
  • NiguardaRecruiting
  • AOU Federico IIRecruiting
  • Policlinico UniversitarioRecruiting
  • Giovanni Paolo IIRecruiting
  • Tergooi MCRecruiting
  • Jeroen Bosch ZiekenhuisRecruiting
  • Albert Schweitzer ZiekenhuisRecruiting
  • Maastad University HospitalRecruiting
  • Haga ZiekenhuisRecruiting
  • Hospital Santa MariaRecruiting
  • Hospital General UniversitarioRecruiting
  • Clinic Hospital BarcelonaRecruiting
  • Hospital del MarRecruiting
  • Puerta del mar
  • Hospital Universitario de BellvitgeRecruiting
  • Hosp. Doctor Lucus AugustiRecruiting
  • Hospital Universitario La PrincesaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shortened DAPT followed by P2Y12 inhibitor monotherapy

Dual Antiplatelet Therapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 8, 2021
Last Updated
September 6, 2023
Sponsor
MicroPort CRM
Collaborators
European Cardiovascular Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04753749
Brief Title
Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy
Acronym
TARGET-FIRST
Official Title
Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroPort CRM
Collaborators
European Cardiovascular Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Acute, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2246 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shortened DAPT followed by P2Y12 inhibitor monotherapy
Arm Type
Experimental
Arm Title
Dual Antiplatelet Therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin)
Intervention Description
Subjects will receive DAPT during 1 month post procedure, followed by P2Y12 inhibitor monotherapy (cessation of aspirin) for the next 11 months
Intervention Type
Drug
Intervention Name(s)
Standard DAPT
Intervention Description
Subjects will receive standard treatment: P2Y12 inhibitor and aspirin (DAPT) during 12 months after procedure
Primary Outcome Measure Information:
Title
Net Adverse Clinical and Cerebral Events (NACCE)
Description
(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)
Time Frame
11 months post randomization
Title
Bleeding events
Description
(Number of participants with first occurrence of) bleeding events (BARC 2,3 or 5)
Time Frame
11 months post randomization

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Bouchez
Phone
0033146013409
Email
ext-david.bouchez@crm.microport.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yann Poezevara
Phone
0033146013409
Email
yann.poezevara@crm.microport.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Tarantini, Pr
Organizational Affiliation
Padova University Hospital, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cayla Guillaume, Pr
Organizational Affiliation
Nîmes University Hospital, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Smits Peter, Pr
Organizational Affiliation
Maastad University Hospital, Netherlands
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinikum
City
St Pölten
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MASCHERBAUER J
Facility Name
CHU Annecy
City
Annecy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MANGIN L
Facility Name
Clinique Roseraie
City
Aubervilliers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BENAMER H
Facility Name
CH Bastia
City
Bastia
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BOUERI Z
Facility Name
CHU Caen
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BEYGUI F
Facility Name
CH Chartres
City
Chartres
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RANGE G
Facility Name
CH Cherbourg
City
Cherbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BEYGUI F
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MOTREFF P
Facility Name
CHU Dijon
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
COTTIN Y
Facility Name
CH Haguenau
City
Haguenau
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DE POLI F
Facility Name
CHU Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LEMESLE G
Facility Name
CH St Joseph/St Luc
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RANC S
Facility Name
CHU La Timone
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CUISSET T
Facility Name
Hôpital Jacques Cartier
City
Massy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P Garot
Facility Name
CHU Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MACIA JC
Facility Name
Clinique Millénaire
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PIOT C
Facility Name
CHU Nîmes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CAYLA G
Facility Name
CHU Reims
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FARROUX L
Facility Name
Clinique St Hilaire
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GODIN M
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LHERMUSIER T
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honton B
Facility Name
Humanitas - Gavazzeni
City
Bergamo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D Cao
Facility Name
Clinica Montevergine
City
Mercogliano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SALEMME L
Facility Name
Niguarda
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
OREGLIA J
Facility Name
AOU Federico II
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ESPOSITO G
Facility Name
Policlinico Universitario
City
Padova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TARANTINI G
Facility Name
Giovanni Paolo II
City
Ragusa
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NICOSIA A
Facility Name
Tergooi MC
City
Blaricum
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CAMBERO M
Facility Name
Jeroen Bosch Ziekenhuis
City
Den Bosch
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
POLAD J
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
OEMRAWSINGH R
Facility Name
Maastad University Hospital
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SMITS P
Facility Name
Haga Ziekenhuis
City
The Hague
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Somi
Facility Name
Hospital Santa Maria
City
Lisbon
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P Cardoso
Facility Name
Hospital General Universitario
City
Alicante
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RUIZ-NODAR JM
Facility Name
Clinic Hospital Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BRUGALETTA S
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VAQUERIZO B
Facility Name
Puerta del mar
City
Cadiz
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A Guttierez
Facility Name
Hospital Universitario de Bellvitge
City
L'Hospitalet De Llobregat
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GOMEZ-HOSPITAL J-A
Facility Name
Hosp. Doctor Lucus Augusti
City
Lugo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R Ocaranza
First Name & Middle Initial & Last Name & Degree
R Ocaranza
Facility Name
Hospital Universitario La Princesa
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
F Alfonso

12. IPD Sharing Statement

Citations:
PubMed Identifier
36999409
Citation
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.
Results Reference
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Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy

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