Myocardial Infarction, Acute, Coronary Artery Disease
Conditions
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.
Interventions
DRUGShortened 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
DRUGStandard DAPT
Subjects will receive standard treatment: P2Y12 inhibitor and aspirin (DAPT) during 12 months after procedure
Sponsors
European Cardiovascular Research Center
MicroPort CRM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Adverse Clinical and Cerebral Events (NACCE) | 11 months post randomization | (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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, or stroke | At 1 month, 6 months and 12 months | (Number of participants with first occurrence of) all-cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, or stroke |
| Primary endpoint component 5 - BARC 3 and 5 bleeding events | At 1 month, 6 months and 12 months | (Number of participants with first occurrence of) BARC 3 and 5 bleeding events |
| All-cause death or non-fatal myocardial infarction | At 1 month, 6 months and 12 months | (Number of patients with first occurrence of) all-cause death or non-fatal myocardial infarction |
| Major Adverse Cardiac and Cerebral Events (MACCE) - Patient | At 1 month, 6 months and 12 months | 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) |
| Target Lesion Failure - Device | At 1 month, 6 months and 12 months | Device oriented composite endpoint of Target Lesion Failure (cardiac death, target vessel related myocardial infarction, target lesion Ischemia Driven-revascularization) |
| Major Adverse Cardiac and Cerebral events (MACE) - Events | At 1 Month, 6 months and 12 months | Number of Major Adverse Cardiac and Cerebral events (MACE) |
| Primary endpoint component 3 - Stent thrombosis | At 1 months, 6 months and 12 months | Definite or probable stent thrombosis |
| Main secondary endpoint component 2 - BARC 3 events | At 1 month, 6 months and 12 months | (Number of patients with occurrence of) BARC 3 events |
| Main secondary endpoint component 3 - BARC 5 events | At 1 month, 6 months and 12 months | (Number of patients with occurrence of) BARC 5 events |
| Main secondary endpoint component 1 - BARC 2 events | At 1 month, 6 months and 12 months | (Number of patients with occurrence of) BARC 2 events |
| Cardiovascular death | At 1 months, 6 months and 12 months | Number of patients with cardiovascular death |
| Bleeding events | 11 months post randomization | (Number of participants with first occurrence of) bleeding events (BARC 2,3 or 5) |
| Non cardiac death | At 1 month, 6 months and 12 months | Number of patients with non cardiac death |
| Primary endpoint component 2 - Myocardial infarction | At 1 month, 6 months and 12 months | Number of patients with myocardial infarction |
| Cardiac death or non-fatal myocardial infarction | At 1 month, 6 months and 12 months | (Number of patients with first occurrence of) cardiac death or non-fatal myocardial infarction |
| Cardiac death, myocardial infarction, or definite/probable stent thrombosis | At 1 month, 6 months and 12 months | (Number of patients with first occurrence of) cardiac death, myocardial infarction, or definite/probable stent thrombosis |
| Cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke | 1 month, 6 months and 12 months | (Number of patients with first occurrence of) cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke |
| Primary endpoint component 4 - Ischemic stroke | At 1 month, 6 months and 12 months | (Number of patients with occurrence of) ischemic stroke |
| Haemorrhagic stroke | At 1 month, 6 months and 12 months | (Number of patients with occurrence of) haemorrhagic stroke |
| Ischemia-driven target lesion revascularization | At 1 month, 6 months and 12 months | (Number of patients with) Ischemia-driven target lesion revascularization |
| Ischemia-driven target vessel revascularization | At 1 month, 6 months and 12 months | (Number of patients with) Ischemia-driven target vessel revascularization |
| Cardiovascular death, myocardial infarction, or ischemic stroke | At 1 month, 6 months and 12 months | (Number of patients with first occurrence of) cardiovascular death, myocardial infarction, or ischemic stroke |
| Primary endpoint component 1 - All cause death | At 1 month, 6 months and 12 months | (Number of patients with) all cause death |
| Cardiac death | At 1 month, 6 months and 12 months | Number of patients with cardiac death |
Countries
Austria, France, Italy, Netherlands, Portugal, Spain
Outcome results
None listed