A multicenter, single arm, open-label trial of prasugrel monotherapy after PCI with the new-generation thin-strut biodegradable polymer everolimus-eluting SYNERGY stent in consecutive patients with chronic coronary syndrome or non-ST-elevation acute coronary syndromes.

JRCT ID: jRCTs042200053

Registered date:22/10/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Acute coronary syndrome
• Date of first enrollment: 24/12/2020
• Target sample size: 400
• Study type: Interventional
• Intervention(s): Prasugrel monotherapy after coronary stent placement

Outcome(s)

Primary Outcome

-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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

<Phase1>
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 (<20 percent), no edge dissection, no thrombus, no major side branch occlusion, no-reflow, no major stent underexpansion or major stent incomplete apposition.
2.Everolimus-eluting SYNERGY stent implantation was performed to treat:
a) patients with at least one stenosis (angiographic, visually determined de novo
lesions with >=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 <23 prior to everolimus-eluting SYNERGY stent implantation;
3.Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Certified Clinical Research Review Board.

<Phase2>
1.Patients with diagnosed Non ST-elevation acute coronary syndrome
2.Patients anatomical SYNTAX Score <23 prior to everolimus-eluting SYNERGY stent implantation;
3.Patient has been informed of the nature of the study and agrees to its requirements and has provided written informed consent as approved by the Certified Clinical Research Review Board.
4.Successful primary 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 (<20 percent), edge dissection, thrombus, major side branch occlusion, no-reflow at the end of the procedure, major stent under expansion or major stent incomplete apposition and absence of persistent chest pain after the procedure.
5.Everolimus-eluting SYNERGY stent implantation was performed to treat:
a) patients with at least one stenosis (angiographic, visually determined de novo lesions with >=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.

Exclude criteria

<Phase1>
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 <10 g/dL or other evidence of active bleeding;
23.Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy;
24.Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with prasugrel;
25.Participation in another trial with an investigational drug or device;
26.Co-morbidity associated with life expectancy less than 1 year;
27.Assessment that the subject is not likely to comply with the study procedures or have complete follow-up;
28.Known drug or alcohol dependence within the past 12 months as judged by the investigator.
29.Patients deemed inappropriate by the physician

<Phase2>
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 non-SYNERGY stents in the last 6 months;
8.Patient with following (target) lesion characteristics:
- Saphenous or arterial graft
- in-stent (re)stenosis;
9.Patients with any previous history of stent thrombosis;
10.Concomitant cardiac valve disease requiring invasive therapy (reconstruction or replacement);
11.Known allergy to aspirin, prasugrel (or ticagrelor) or diagnosed lactose intolerance;
12.Previous stroke or transient ischemic cerebrovascular accident (TIA);
13.Previous history of intracranial haemorrhage or other intracranial pathology associated with increased bleeding risk;
14.Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy;
15.Hemodynamic instability or cardiogenic shock;
16.Recurrent or ongoing chest pain refractory to medical treatment;
17.Life-threatening arrhythmias or cardiac arrest;
18.Mechanical complications of MI;
19.Acute heart failure;
20.Patients with intermittent ST-segment elevation
21.Atrial fibrillation or other indication for oral anticoagulant therapy;
22.Myocarditis;
23.Cardiomyopathy;
24.Patients treated with hemodialysis;
25.Haemoglobin <10 g/dL or other evidence of active bleeding;
26.Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with prasugrel;
27.Participation in another trial with an investigational drug or device;
28.Co-morbidity associated with life expectancy less than 1 year.
29.Assessment that the subject is not likely to comply with the study procedures or have complete follow-up;
30.Known drug or alcohol dependence within the past 12 months as judged by the investigator;
31.Patients deemed inappropriate by the physician

Related Information

• Primary Sponsor: Muramatsu Takashi
• Source(s) of Monetary Support: Boston Scientific Japan Corporation