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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04753749
Other study ID # SFHI01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 25, 2021
Est. completion date April 30, 2025

Study information

Verified date March 2024
Source MicroPort CRM
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2248
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Austria Universitätsklinikum St Pölten
France 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
Italy Humanitas - Gavazzeni Bergamo
Italy Clinica Montevergine Mercogliano
Italy Niguarda Milan
Italy AOU Federico II Napoli
Italy Policlinico Universitario Padova
Italy Giovanni Paolo II Ragusa
Netherlands Tergooi MC Blaricum
Netherlands Jeroen Bosch Ziekenhuis Den Bosch
Netherlands Albert Schweitzer Ziekenhuis Dordrecht
Netherlands Maastad University Hospital Rotterdam
Netherlands Haga Ziekenhuis The Hague
Portugal Hospital Santa Maria Lisbon
Spain 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

Sponsors (2)

Lead Sponsor Collaborator
MicroPort CRM European Cardiovascular Research Center

Countries where clinical trial is conducted

Austria,  France,  Italy,  Netherlands,  Portugal,  Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Bleeding events (Number of participants with first occurrence of) bleeding events (BARC 2,3 or 5) 11 months post randomization
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