Clinical trial NCT04753749: Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy
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
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction, Acute
Coronary Artery Disease
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2021-02-15
Enrollment: 2248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Net Adverse Clinical and Cerebral Events (NACCE)
timeFrame: 11 months post randomization
measure: Bleeding events
timeFrame: 11 months post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: St Pölten
country: Austria
facility: Universitätsklinikum
city: Annecy
country: France
facility: CHU Annecy
city: Aubervilliers
country: France
facility: Clinique Roseraie
city: Bastia
country: France
facility: CH Bastia
city: Caen
country: France
facility: CHU Caen
city: Chartres
country: France
facility: CH Chartres
city: Cherbourg
country: France
facility: CH Cherbourg
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Dijon
country: France
facility: CHU Dijon
city: Haguenau
country: France
facility: CH Haguenau
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: CH St Joseph/St Luc
city: Marseille
country: France
facility: CHU La Timone
city: Massy
country: France
facility: Hôpital Jacques Cartier
city: Montpellier
country: France
facility: CHU Montpellier
city: Montpellier
country: France
facility: Clinique Millénaire
city: Nîmes
country: France
facility: CHU Nîmes
city: Reims
country: France
facility: CHU Reims
city: Rouen
country: France
facility: Clinique St Hilaire
city: Toulouse
country: France
facility: CHU Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bergamo
country: Italy
facility: Humanitas - Gavazzeni
city: Mercogliano
country: Italy
facility: Clinica Montevergine
city: Milan
country: Italy
facility: Niguarda
city: Napoli
country: Italy
facility: AOU Federico II
city: Padova
country: Italy
facility: Policlinico Universitario
city: Ragusa
country: Italy
facility: Giovanni Paolo II
city: Blaricum
country: Netherlands
facility: Tergooi MC
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maastad University Hospital
city: The Hague
country: Netherlands
facility: Haga Ziekenhuis
city: Lisbon
country: Portugal
facility: Hospital Santa Maria
city: Alicante
country: Spain
facility: Hospital General Universitario
city: Barcelona
country: Spain
facility: Clinic Hospital Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Cadiz
country: Spain
facility: Puerta del mar
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
city: Lugo
country: Spain
facility: Hosp. Doctor Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
Study officials:
affiliation: Padova University Hospital, Italy
name: Giuseppe Tarantini, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Nîmes University Hospital, France
name: Cayla Guillaume, Pr
role: STUDY_DIRECTOR
affiliation: Maastad University Hospital, Netherlands
name: Smits Peter, Pr
role: STUDY_DIRECTOR
References:
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.