Patients with clinically stable, low to moderate complexity acute Myocardial Infarction (MI
Conditions
Interventions
Pharmaceutical Form: Tablet
Pharmaceutical Form: Tablet
Pharmaceutical Form: Tablet
Pharmaceutical Form: Tablet
Sponsors
Sorin CRM SAS (Microport CRM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for enrolment: Clinical • Subject is = 18 years old •Subject has been hospitalised for troponin-positive Non-ST-Elevation MI, requiring early invasive treatment (PCI), or ST-Elevation MI requiring primary PCI, and this PCI occurred within the last 7 days •Subject is eligible for per-protocol antiplatelet treatments •Subject understands and agrees with the trial requirements and procedures, and provides written informed consent before any trial-specific tests or procedures are performed •Subject is willing to comply with all protocol requirements including antiplatelet treatment strategies and follow-up visits Procedural/angiographic (related to the treatment of the (N)STEMI •Successful revascularization: -Successful delivery and deployment of the Firehawk stent(s), with final residual stenosis of =65 years) yes F.1.3.1 Number of subjects for this age range 1446
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria are not eligible: •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 after the enrolment •Need for Oral Anti-Coagulation medications (or NOAC) •Ischemic stroke or intracerebral hemorrhage (spontaneous or traumatic) within 12 months prior to index procedure •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 prior to index procedure (or currently receiving chemotherapy or planned to receive chemotherapy) •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 (<100,000/µL) •Expected non-adherence to study protocol (such as current problems with substance abuse, severe impairment of cognitive skills, …) •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 (e.g., cobalt chromium alloy, rapamycin, or structurally related compounds, polymer or individual components, P2Y12 inhibitors, or aspirin). •Subject participates in another interventional (device or drug) clinical trial within 12 months after the index procedure •Subject is a woman who is pregnant, nursing or with known intention to procreate within 12 months after the index procedure (woman of child-bearing potential who is sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)). Investigator may require a pregnancy test to be performed within 7 days prior to the enrolment in women of child-bearing potential) Angiographic: •Any of : -In-stent restenosis or thrombosis -Chronic total occlusion -Severe calcification -True bifurcation disease (Medina class x,x,1) and side branch diameter = 2mm (visual reference visual diameter) or bifurcation treated with 2 stents -Left main coronary artery lesion -Residual untreated dissection = C -Implantation of a non-study stent •Extent and severity of disease is such that patient is deemed to receive preferentially CABG within 1 year (based on current ESC guidelines)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate a modified Anti-Platelet Therapy, associated with low-dose rapamycin DES Firehawk in Acute Myocardial Infarction Patients treated with complete revascularization strategy, in reaching non inferior NACE (among clinically stable, low to moderate complexity acute MI patients). ;Secondary Objective: The secondary objective is to evaluate a modified Anti-Platelet Therapy, associated with low-dose rapamycin DES Firehawk in Acute Myocardial Infarction patients treated with complete revascularization strategy, in reducing bleeding events (among clinically stable, low to moderate complexity acute MI patients). ;Primary end point(s): Net Adverse Clinical and Cerebral Events (NACCE) defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 11 months post randomization (12 months post index procedure).;Timepoint(s) of evaluation of this end point: 11 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The main secondary endpoint (powered) is BARC type 2, 3 or 5 bleeding events at 11 months post-randomization. Other secondary endpoints (exploratory) are clinical endpoints at 1 month, 6 months and 12 months: •All-cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, or stroke •BARC 3 and 5 bleeding events •All-cause death or non-fatal myocardial infarction •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) •Device oriented composite endpoint of Target Lesion Failure (cardiac death, target vessel related myocardial infarction, target lesion Ischemia Driven-revascularization) •MACE (cardiovascular death, myocardial infarction, Ischemia Driven-revascularization) •Definite or probable stent thrombosis •BARC 3 events •BARC 5 events •BARC 2 events •Cardiovascular death •Cardiac death •Non-cardiac death •Myocardial infarction •Cardiac death or non-fatal myocardial infarction •Cardiac death, myocardial infarction, or definite/probable stent thrombosis •Cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke •Ischemic stroke •Haemorrhagic stroke •Ischemia-driven target lesion revascularization •Ischemia-driven target vessel revascularization •Cardiovascular death, myocardial infarction, or ischemic stroke and each of the components of the primary and main secondary endpoints;Timepoint(s) of evaluation of this end point: Main secondary Endpoint 11 months post randomization. Other secondary endpoints at 1 month, 6 months and 12 months. | — |
Countries
Austria, Belgium, France, Italy, Netherlands, Portugal, Spain, Switzerland
Contacts
Public ContactClinical Affairs
Sorin CRM SAS (Microport CRM)
Outcome results
None listed