Chronic Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Conditions
Keywords
prasugrel monotherapy
Brief summary
The ASET Japan Pilot study is a multicenter, single arm, open-label trial of single antiplatelet therapy with prasugrel for patients undergoing successful and optimal Percutaneous Coronary Intervention (PCI) for Chronic Coronary Syndrome (CCS) and Non-ST elevation Acute coronary syndrome (NSTE-ACS). The enrollment consists of two phases: i) 200 patients presenting with CCS; ii) 200 patients presenting with NSTE-ACS. The patients will be loaded with standard dual antiplatelet therapy according to local practice (usually aspirin 81 to 330 mg and clopidogrel 300 mg or prasugrel 20 mg or ticagrelor 180 mg, unless patient is on long-term therapy) prior to the PCI procedure. After PCI, if the results are considered to be satisfactory by the operator based on clinical (e.g. clinical status, ECG, etc.), angiographic and/or findings from intracoronary imaging, only then patients will be enrolled in the study and loaded with prasugrel 20 mg if the patients have not loaded prasugrel prior to PCI or have not taken a maintenance dose of prasugrel before the index PCI. Patients continued with prasugrel only (3.75 mg once a day) for three months in CCS patients and for 12 months in NSTE-ACS patients. Aspirin, clopidogrel, and ticagrelor will be discontinued just after the index procedure. i. CCS patients (phase 1): At the 3-months follow-up visit, prasugrel monotherapy will be replaced by aspirin monotherapy or dual-antiplatelet therapy according to local standard of care. Clinical follow-up with office visit will be performed at 3 months and telephone contacts at 1, and 4 months (final follow-up). ii. NSTE-ACS patients (phase 2): At the 12-months follow-up visit, prasugrel monotherapy will be replaced by aspirin monotherapy for an observational period of 1 month, followed by antiplatelet treatment according to local practice. Clinical follow-up with office visit will be performed at 1 and 12 months and telephone contacts at 3, 6, 9 and 13 months (final follow-up). All events will be adjudicated by an independent clinical events committee (CEC). An independent Data Safety and Monitoring Board (DSMB) will monitor the individual and collective safety of the patients in the study during enrolment of CCS patients and up to 3 months follow-up of CCS patients, and during enrollment of NSTE-ACS patients and up to 12 months follow-up of NSTE-ACS patients (timepoint for primary endpoint).
Interventions
Prasugrel Monotherapy according to the local dosage (Loading : 20mg, maintenance: 3.75mg/day)
Sponsors
Fujita Health University
Boston Scientific Japan K.K.
National University of Ireland, Galway, Ireland
Meditrix Corp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria for CCS patients (phase 1) : 1. Successful PCI with optimal acute stent implantation of one or more SYNERGY stent(s). 2. SYNERGY stent implantation was performed to treat: 1. at least one de novo lesion with ≥50% diameter stenosis determined by visual assessment in at least one native coronary artery with a vessel size between 2.25 mm and 5.0 mm in diameter. 2. Non-acute coronary disease, with normal cardiac biomarker values prior to the PCI procedure, and evidences of myocardial ischemia by symptoms or non-invasive/invasive testing. 3. patients with anatomical SYNTAX Score \< 23 prior to PCI 3. Patient has provided written informed consent as approved by the Ethical Committee of the respective clinical site. Inclusion Criteria for NSTE-ACS patients (phase 2) : 1. Patients with diagnosed Non ST-elevation acute coronary syndrome 2. Patients with anatomical SYNTAX Score \< 23 prior to PCI 3. Patient provided written informed consent as approved by the Ethical Committee of the respective clinical site Post PCI criteria for NSTE-ACS patients 1. Patient is free of angina symptoms at the end of PCI procedure. 2. Successful PCI with optimal acute stent implantation of one or more SYNERGY stent(s). 3. SYNERGY stent implantation was performed to treat at least one de novo lesion with ≥50% diameter stenosis determined by visual assessment in at least one native coronary artery with a vessel size between 2.25 mm and 5.0 mm in diameter.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Primary Ischemic Endpoint events (CCS) | 3 months | Composite of cardiac death, target-vessel myocardial infarction (spontaneous \>48 hours) or definite stent thrombosis. |
| Rate of Primary Ischemic Endpoint events (NSTE-ACS) | 12 months | Composite of cardiac death, target-vessel myocardial infarction (spontaneous \>48 hours) or definite stent thrombosis. |
| Rate of Primary Bleeding Endpoint event (CCS) | 3 months | BARC 3 or 5 bleeding |
| Rate of Primary Bleeding Endpoint event (NSTE-ACS) | 12 months | BARC 3 or 5 bleeding |
Countries
Ireland, Japan
Outcome results
None listed