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

Study Overview
=================
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.

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

Conditions
-----------------
Myocardial Infarction, Acute, Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin)
* Drug: Standard DAPT


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shortened DAPT followed by P2Y12 inhibitor monotherapy<br> | Drug: Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin)<br>* Subjects will receive DAPT during 1 month post procedure, followed by P2Y12 inhibitor monotherapy (cessation of aspirin) for the next 11 months<br>|
| Active Comparator: Dual Antiplatelet Therapy<br> | Drug: Standard DAPT<br>* Subjects will receive standard treatment: P2Y12 inhibitor and aspirin (DAPT) during 12 months after procedure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 
| Bleeding events | (Number of participants with first occurrence of) bleeding events (BARC 2,3 or 5) | 11 months post randomization |