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

NCT ID: NCT04753749

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-25
• Study Completion Date: 2025-05-05

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.

Conditions

Myocardial Infarction, Acute; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Shortened DAPT followed by P2Y12 inhibitor monotherapy

Group Type: EXPERIMENTAL

Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin)

Intervention Type: DRUG

Subjects will receive DAPT during 1 month post procedure, followed by P2Y12 inhibitor monotherapy (cessation of aspirin) for the next 11 months

Dual Antiplatelet Therapy

Group Type: ACTIVE_COMPARATOR

Standard DAPT

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Standard DAPT

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Cardiovascular Research Center

NETWORK

Sponsor Role: collaborator

MicroPort CRM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Tarantini, Pr

Role: PRINCIPAL_INVESTIGATOR

Padova University Hospital, Italy

Cayla Guillaume, Pr

Role: STUDY_DIRECTOR

Nîmes University Hospital, France

Smits Peter, Pr

Role: STUDY_DIRECTOR

Maastad University Hospital, Netherlands

Locations

Universitätsklinikum

Sankt Pölten, , Austria

CHU Annecy

Annecy, , France

Clinique Roseraie

Aubervilliers, , France

CH Bastia

Bastia, , France

CHU Caen

Caen, , France

CH Chartres

Chartres, , France

CH Cherbourg

Cherbourg, , France

CHU Clermont-Ferrand

Clermont-Ferrand, , France

CHU Dijon

Dijon, , France

CH Haguenau

Haguenau, , France

CHU Lille

Lille, , France

CH St Joseph/St Luc

Lyon, , France

CHU La Timone

Marseille, , France

Hôpital Jacques Cartier

Massy, , France

CHU Montpellier

Montpellier, , France

Clinique Millénaire

Montpellier, , France

CHU Nîmes

Nîmes, , France

CHU Reims

Reims, , France

Clinique St Hilaire

Rouen, , France

CHU Toulouse

Toulouse, , France

Clinique Pasteur

Toulouse, , France

Humanitas - Gavazzeni

Bergamo, , Italy

Clinica Montevergine

Mercogliano, , Italy

Niguarda

Milan, , Italy

AOU Federico II

Napoli, , Italy

Policlinico Universitario

Padua, , Italy

Giovanni Paolo II

Ragusa, , Italy

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Tergooi MC

Blaricum, , Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, , Netherlands

Maastad University Hospital

Rotterdam, , Netherlands

Haga Ziekenhuis

The Hague, , Netherlands

Hospital Santa Maria

Lisbon, , Portugal

Hospital General Universitario

Alicante, , Spain

Clinic Hospital Barcelona

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Puerta del mar

Cadiz, , Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, , Spain

Hosp. Doctor Lucus Augusti

Lugo, , Spain

Hospital Universitario La Princesa

Madrid, , Spain

Countries

Austria; France; Italy; Netherlands; Portugal; Spain

References

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.

Reference Type: BACKGROUND

PMID: 36999409 (View on PubMed)

Tarantini G, Honton B, Paradies V, Lemesle G, Range G, Godin M, Mangin L, Cuisset T, Ruiz-Nodar JM, Brugaletta S, Lhermusier T, Piot C, De Poli F, Macia JC, Motreff P, Madera-Cambero M, Beygui F, Riccini P, Ranc S, Oreglia JA, Vaquerizo B, Poezevara Y, Bouchez D, Smits PC, Cayla G; TARGET-FIRST Investigators. Early Discontinuation of Aspirin after PCI in Low-Risk Acute Myocardial Infarction. N Engl J Med. 2025 Aug 31. doi: 10.1056/NEJMoa2508808. Online ahead of print.

Reference Type: DERIVED

PMID: 40888726 (View on PubMed)

Other Identifiers

SFHI01

Identifier Type: -

Identifier Source: org_study_id