Stable Angina Clinical Trial
— INNOVATIONOfficial title:
EndothelIal progeNitor Cell Capture steNt With 1-mOnth Dual Antiplatelet Therapy Versus eVerolimus-eluting Stent With stAndard 12-month Dual anTIplatelet Therapy in Elderly (≥ 70 Year) With Stable corONary Artery Disease - INNOVATION Trial
Verified date | December 2013 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
Thanks to rapid reendothelialization derived from the pro-healing property of the EPC
capture stent, 1-month dual antiplatelet therapy (DAPT) is recommended after EPC capture
stent implantation. Shorter maintenance of dual antiplatelet therapy might minimize the risk
for stent thrombosis in cases of discontinuation of antiplatelet regimen and prevent
wasteful medications and bleeding complications related with dual antiplatelet therapy.
Thus, the EPC capture stent might be valuable for the elderly because they are vulnerable to
premature discontinuation of DAPT.
On the other hand, statin upstream therapy has gained popularity because it seems to reduce
periprocedural myocardial injury especially in ACS through its pleiotrophic effect like
plaque stabilization. However, the benefit of pretreatment of statin in patients with stable
angina remains controversial. It is reported that statin administration could increase EPC
level by accelerated differentiation towards the endothelial progenitor lineage.
We hypothesize that the EPC capture stent with 1-month dual antiplatelet therapy is
non-inferior to DES in the elderly subjects with stable coronary artery disease. To test
this hypothesis, we will perform a multi-center, randomized, prospective trial aimed at
demonstrating the efficacy and safety of the EPC capture stent with 1-month DATP versus EES
with standard 12-month DAPT in elderly patients with stable coronary occlusive disease in
real world practice.
Status | Terminated |
Enrollment | 1 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
Inclusion Criteria: - Age =70 years patients with coronary artery disease (=stable angina CCS III, Unstable angina IIb - patients with signed informed consent - significant coronary artery stenosis (>50%) considered for coronary stenting - Reference vessel diameter of 2.5 to 4.0 mm Exclusion Criteria: - The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Everolimus, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.) - Systemic (intravenous) Everolimus use within 12 months - The patients who are receiving anticoagulants or anti-platelet medications besides aspirin & clopidogrel - History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or refuses blood transfusions - Baseline hemogram with Hb<10g/dL or PLT count <100,000/µL - Severe Hepatic dysfunction (= 3 times normal reference values) - Significant renal dysfunction (Serum creatinine = 2.0 mg/dl) - Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months - Patients with LV systolic dysfunction (LVEF<40%) or in cardiogenic shock - Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment) - Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period - An elective surgical procedure is planned that would necessitate interruption of DAPT during the first 12 months post enrollment |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yonsei university Wonju College of Medicine | Wonju | Gangwon-do |
Lead Sponsor | Collaborator |
---|---|
Yonsei University | OrbusNeich, Yuhan Corporation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major adverse cardiovascular events | The incidence of the composite of cardiovascular death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), or stent thrombosis following randomly assigned coronary stent implantation | 12 months | Yes |
Secondary | Each component of the primary composite endpoint at 12 months | 12 months | Yes | |
Secondary | In-stent late loss and angiographic pattern of restenosis at 13 months | 13 months | Yes | |
Secondary | In-sent and in-segment % diameter stenosis (%DS) at 13 months | 13 months | Yes | |
Secondary | Overall incidence of deferring or declining the request to discontinue dual antiplatelet between 1-12 months due to major and minor operations or invasive procedures | 12 months | Yes | |
Secondary | Cost-reducing effect according the duration of duration of anti-platelet therapy | 12 months | No | |
Secondary | Periprocedural myocardial infarction | 12 months | Yes | |
Secondary | Bleeding defined by Bleeding Academic Research Consortium (BARC) | Bleeding Academic Research Consortium Definition for Bleeding Type 0 to Type 5 | 12 months | Yes |
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