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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shortened DAPT followed by P2Y12 inhibitor monotherapy | Experimental |
| |
| Dual Antiplatelet Therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding events | (Number of participants with first occurrence of) bleeding events (BARC 2,3 or 5) | 11 months post randomization |
| All-cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, or stroke |
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Inclusion Criteria (General):
Inclusion Criteria (Procedural/angiographic):
Successful revascularization
All treated lesions:
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):
Exclusion Criteria (Procedural/Angiographic):
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum | Sankt Pölten | Austria | ||||
| CHU Annecy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36999409 | Background | 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. | |
| 40888726 |
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| Standard DAPT | Drug | Subjects will receive standard treatment: P2Y12 inhibitor and aspirin (DAPT) during 12 months after procedure |
|
(Number of participants with first occurrence of) 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 | (Number of participants with first occurrence of) BARC 3 and 5 bleeding events | At 1 month, 6 months and 12 months |
| All-cause death or non-fatal myocardial infarction | (Number of patients with first occurrence of) all-cause death or non-fatal myocardial infarction | At 1 month, 6 months and 12 months |
| Major Adverse Cardiac and Cerebral Events (MACCE) - Patient | Patient-oriented composite of major adverse cardiac and cerebral events (MACCE) including all-cause death, myocardial infarction, definite/probable stent thrombosis, any stroke, any Ischemia driven repeat revascularization, or BARC bleeding events (type 2, 3, or 5) | At 1 month, 6 months and 12 months |
| Target Lesion Failure - Device | Device oriented composite endpoint of Target Lesion Failure (cardiac death, target vessel related myocardial infarction, target lesion Ischemia Driven-revascularization) | At 1 month, 6 months and 12 months |
| Major Adverse Cardiac and Cerebral events (MACE) - Events | Number of Major Adverse Cardiac and Cerebral events (MACE) | At 1 Month, 6 months and 12 months |
| Primary endpoint component 3 - Stent thrombosis | Definite or probable stent thrombosis | At 1 months, 6 months and 12 months |
| Main secondary endpoint component 2 - BARC 3 events | (Number of patients with occurrence of) BARC 3 events | At 1 month, 6 months and 12 months |
| Main secondary endpoint component 3 - BARC 5 events | (Number of patients with occurrence of) BARC 5 events | At 1 month, 6 months and 12 months |
| Main secondary endpoint component 1 - BARC 2 events | (Number of patients with occurrence of) BARC 2 events | At 1 month, 6 months and 12 months |
| Cardiovascular death | Number of patients with cardiovascular death | At 1 months, 6 months and 12 months |
| Cardiac death | Number of patients with cardiac death | At 1 month, 6 months and 12 months |
| Non cardiac death | Number of patients with non cardiac death | At 1 month, 6 months and 12 months |
| Primary endpoint component 2 - Myocardial infarction | Number of patients with myocardial infarction | At 1 month, 6 months and 12 months |
| Cardiac death or non-fatal myocardial infarction | (Number of patients with first occurrence of) cardiac death or non-fatal myocardial infarction | At 1 month, 6 months and 12 months |
| Cardiac death, myocardial infarction, or definite/probable stent thrombosis | (Number of patients with first occurrence of) cardiac death, myocardial infarction, or definite/probable stent thrombosis | At 1 month, 6 months and 12 months |
| Cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke | (Number of patients with first occurrence of) cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke | 1 month, 6 months and 12 months |
| Primary endpoint component 4 - Ischemic stroke | (Number of patients with occurrence of) ischemic stroke | At 1 month, 6 months and 12 months |
| Haemorrhagic stroke | (Number of patients with occurrence of) haemorrhagic stroke | At 1 month, 6 months and 12 months |
| Ischemia-driven target lesion revascularization | (Number of patients with) Ischemia-driven target lesion revascularization | At 1 month, 6 months and 12 months |
| Ischemia-driven target vessel revascularization | (Number of patients with) Ischemia-driven target vessel revascularization | At 1 month, 6 months and 12 months |
| Cardiovascular death, myocardial infarction, or ischemic stroke | (Number of patients with first occurrence of) cardiovascular death, myocardial infarction, or ischemic stroke | At 1 month, 6 months and 12 months |
| Primary endpoint component 1 - All cause death | (Number of patients with) all cause death | At 1 month, 6 months and 12 months |
| Primary endpoint component 2 - Myocardial infarction | (Number of patients with occurrence of) myocardial infarction | At 1 month, 6 months and 12 months |
| 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 | Naples | Italy |
| Policlinico Universitario | Padova | 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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