Acute coronary syndrome ACS
Conditions
Interventions
Prasugrel monotherapy after coronary stent placement
Sponsors
Muramatsu Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Successful PCI with optimal acute stent implantation results (based on local standard of care by angiography and/or findings from intracoronary imaging and on investigators discretion) of one or more everolimus-eluting SYNERGY stent(s). Typically, optimal acute coronary stenting result is a combination of successful stent implantation at the target lesion with absence of significant residual diameter stenosis (=50 percent DS) in at least one major epicardial territory (LAD and/or side branch, CX and/or side branch, RCA and/or side branch) with a vessel size between 2.25 mm and 5.0 mm in diameter supplying viable myocardium; b) Non-acute coronary disease, with normal cardiac troponin values prior to the PCI procedure, and evidences of myocardial ischemia by symptoms or non-invasive testing (e.g. treadmill exercise test, radionuclide scintigraphy, stress echocardiography); c) patients anatomical SYNTAX Score 1.Patients with diagnosed Non ST-elevation acute coronary syndrome 2.Patients anatomical SYNTAX Score =50 percent DS) in at least one major epicardial territory (LAD and/or side branch, CX and/or side branch, RCA and/or side branch) with a vessel size between 2.25 mm and 5.0 mm in diameter supplying viable myocardium; 6.Patient is free of angina symptoms at the end of PCI procedure.
Exclusion criteria
Exclusion criteria: 1.Under the age of 20 years; 2.Unable to give Informed Consent; 3.Females of child-bearing potential unless negative pregnancy test at screening and willing to use effective contraception (i.e. established use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or barrier methods of contraception with spermicide or sole male partner with prior vasectomy and confirmed absence of sperm in ejaculate) for the duration of treatment with study medication. 4.Female who is breastfeeding at time of enrolment; 5.If a stent other than the Synergy stent is implanted at the time of Index PCI. 6. Patients scheduled for staged PCI or surgical intervention after enrollment. 7.Previous PCI with any non-SYNERGY stents in the last 6 months; 8. Patients presenting with acute coronary syndromes 9.Patients with a history of acute coronary syndromes within 12 months 10.Patient with following lesion characteristics prior to everolimus-eluting SYNERGY stent implantation: - Saphenous or arterial graft - in-stent (re)stenosis; 11. Patients with a history of stent thrombosis 12.Concomitant cardiac valve disease requiring invasive therapy (reconstruction or replacement); 13.Atrial fibrillation or other indication for oral anticoagulant therapy; 14.Known allergy to aspirin, prasugrel or diagnosed lactose intolerance; 15.Patients presenting with acute heart failure 16.Patients presenting with active pericardial myocarditis 17.Patients with known cardiomyopathy 18.Patinets treated with hemodialysis; 19.Treatment in the last 10 days or requirement for ongoing treatment with a strong CYP3A4 inhibitor or inducer; 20.Previous stroke or transient ischemic cerebrovascular accident (TIA); 21.Previous history of intracranial haemorrhage or other intracranial pathology associated with increased bleeding risk; 22.Haemoglobin 1.Under the age of 20 years; 2.Unable to give Informed Consent; 3.Females of child-bearing potential unless negative pregnancy test at screening and willing to use effective contraception (i.e. established use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or barrier methods of contraception with spermicide or sole male partner with prior vasectomy and confirmed absence of sperm in ejaculate) for the duration of treatment with study medication; 4.Female who is breastfeeding at time of enrolment; 5.Patients treated with everolimus-eluting SYNERGY stent(s) but who also concomitantly received any other non-study stent at the same procedure (all lesions must be treated with everolimus-eluting SYNERGY stent); 6.Patients scheduled for staged PCI or surgical intervention after enrollment 7.Previous PCI with any no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -The primary endpoint is a composite of cardiac death, target-vessel myocardial infarction* (>48 hours) or definite stent thrombosis at 3 months for CCS patients and at 12 months for NSTE-ACS patients. (see Appendix I for definitions) -BARC 3 or 5 bleeding at 3 months for CCS patients and at 12 months for NSTE-ACS patients. (see Appendix I for definitions) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. each individual component of the primary endpoint 2. all-cause death 3. stroke 4. all MIs 5. repeat revascularization 6. definite/probable/possible stent thrombosis 7. BARC 1-5 bleedings 8. PoCE: a composite of all-cause death, any stroke, any MI, and any revascularization 9. DoCE: a composite of cardiovascular death, MI, and clinically-driven target lesion revascularization 10. NACE equals PoCE + BARC 3 or 5 bleeding | — |
Contacts
Public ContactTakashi Muramatsu
Fujita Health University Hospital
Outcome results
None listed