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

NCT04753749 | Completed DMC

• 1 other identifier: SFHI01
• Study Type: interventional
• Target: 2,248
• Locations: 6 countries
• Sites: 40

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• Bleeding events

  11 months post randomization

• 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

  At 1 month, 6 months and 12 months

• All-cause death or non-fatal myocardial infarction

  At 1 month, 6 months and 12 months

• Major Adverse Cardiac and Cerebral Events (MACCE) - Patient

  At 1 month, 6 months and 12 months

Study Arms (2)

Shortened DAPT followed by P2Y12 inhibitor monotherapy

EXPERIMENTAL

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

Dual Antiplatelet Therapy

ACTIVE COMPARATOR

Drug: Standard DAPT

Interventions

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

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

Shortened DAPT followed by P2Y12 inhibitor monotherapy

Standard DAPT DRUG

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

Dual Antiplatelet Therapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• MicroPort CRM: lead
• European Cardiovascular Research Center: collaborator

Study Sites (40)

Universitätsklinikum

Sankt Pölten, Austria

Location

CHU Annecy

Annecy, France

Location

Clinique Roseraie

Aubervilliers, France

Location

CH Bastia

Bastia, France

Location

CHU Caen

Caen, France

Location

CH Chartres

Chartres, France

Location

CH Cherbourg

Cherbourg, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU Dijon

Dijon, France

Location

CH Haguenau

Haguenau, France

Location

CHU Lille

Lille, France

Location

CH St Joseph/St Luc

Lyon, France

Location

CHU La Timone

Marseille, France

Location

Hôpital Jacques Cartier

Massy, France

Location

CHU Montpellier

Montpellier, France

Location

Clinique Millénaire

Montpellier, France

Location

CHU Nîmes

Nîmes, France

Location

CHU Reims

Reims, France

Location

Clinique St Hilaire

Rouen, France

Location

CHU Toulouse

Toulouse, France

Location

Clinique Pasteur

Toulouse, France

Location

Humanitas - Gavazzeni

Bergamo, Italy

Location

Clinica Montevergine

Mercogliano, Italy

Location

Niguarda

Milan, Italy

Location

AOU Federico II

Napoli, Italy

Location

Policlinico Universitario

Padua, Italy

Location

Giovanni Paolo II

Ragusa, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

Tergooi MC

Blaricum, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Location

Maastad University Hospital

Rotterdam, Netherlands

Location

Haga Ziekenhuis

The Hague, Netherlands

Location

Hospital Santa Maria

Lisbon, Portugal

Location

Hospital General Universitario

Alicante, Spain

Location

Clinic Hospital Barcelona

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Puerta del mar

Cadiz, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Spain

Location

Hosp. Doctor Lucus Augusti

Lugo, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

Related Publications (2)

• 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.

  PMID: 36999409 BACKGROUND

• 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 Nov 27;393(21):2083-2094. doi: 10.1056/NEJMoa2508808. Epub 2025 Aug 31.

  PMID: 40888726 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Giuseppe Tarantini, Pr

  Padova University Hospital, Italy

  PRINCIPAL INVESTIGATOR

• Cayla Guillaume, Pr

  Nîmes University Hospital, France

  STUDY DIRECTOR

• Smits Peter, Pr

  Maastad University Hospital, Netherlands

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 15, 2021
• Study Start: March 25, 2021
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7); AU (1); NL (5); FR (20); IT (6); PT (1)