A study designed to evaluate a modified Anti-Platelet Therapy (drugs that prevent blood platelets from clotting) after implantation of a Firehawk drug-eluting stent (metallic tube, which is covered with a drug and inserted into stenosed blood vessels of the heart in order to keep them open) in patients who have experienced a heart attack and were treated with complete revascularisation (the lesion related to the heart attack and all other significant lesions were treated)
- Conditions
- Patients with clinically stable, low to moderate complexity acute Myocardial Infarction (MItroponine-positive Non-ST-Elevation MI or ST-Elevation MI) requiring primary Percutaneous Coronary Intervention. Subjects will be enrolled after having undergone successful complete revascularization with the study stent (Firehawk). Shortened DAPT of 1 month followed by 11 months P2Y12-Inhibitor only is compared to the current guideline-recommended 12-months DAPT.MedDRA version: 20.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-005933-34-ES
- Lead Sponsor
- Sorin CRM SAS (Microport CRM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 2246
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 <30% (visually) for all target lesions
-No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding).
•All the 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. Physiologic assessment highly recommended for lesions with stenosis between 50% and 69%.
(*) in 1 to 3 vessels.
(**) Complete revascularization performed according to site routine practice and according to the European Society of Cardiology (ESC) guidelines.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1446
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method