EUCTR2020-005933-34-AT
Active, not recruiting
Phase 1
Evaluation of a modified Anti-Platelet Therapy associated with low-dose rapamycin DES Firehawk in Acute Myocardial Infarction Patients treated with complete revascularization strategy - TARGET FIRST
Sorin CRM SAS (Microport CRM)0 sites2,246 target enrollmentMarch 1, 2021
ConditionsPatients 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with clinically stable, low to moderate complexity acute Myocardial Infarction (MI
- Sponsor
- Sorin CRM SAS (Microport CRM)
- Enrollment
- 2246
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following criteria to be eligible for enrolment:
- •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).
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
Outcomes
Primary Outcomes
Not specified
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