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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04753749
• Other study ID #: SFHI01
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute

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