Safety and Efficacy Study of Endothelial Progenitor Cell Capture Stent With 1 Months Dual Antiplatelet Therapy (INNOVATION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01394848
Recruitment Status : Terminated (Previous other study including EPC capture stent raised the issue of safety (significant high incidence of instent restenosis))
First Posted : July 14, 2011
Last Update Posted : December 4, 2013
Yuhan Corporation
Information provided by (Responsible Party):
Seung-Hwan Lee, Yonsei University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Stable Angina Device: Endothelial cell capture stent with 1 month clopidogrel Device: Everolimus eluting stent with 12 month clopidogrel Drug: Atorvastatin 20mg loading Drug: Atorvastatin 80mg loading Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Genous stent group
Genous stent (Endothelial progenitor cell capture stent) insertion in elderly patients with stable coronary artery disease
Device: Endothelial cell capture stent with 1 month clopidogrel
75mg PO clopidogrel per day for 1 months
Other Name: Genous stent

Active Comparator: Xience stent group
Xience Prime V stent (everolimus eluting stent) insertion in elderly patients with stable coronary artery disease
Device: Everolimus eluting stent with 12 month clopidogrel
75mg PO clopidogrel per day for over 12 months
Other Name: Xience stent

Active Comparator: Atorvastatin 20mg group Drug: Atorvastatin 20mg loading
Atorvastatin 20mg loading before index percutaneous coronary intervention
Other Name: Atorvastatin

Active Comparator: Atorvastatin 80mg group Drug: Atorvastatin 80mg loading
Atorvastatin 80mg loading before index percutaneous coronary intervention
Other Name: Atorvastatin

Primary Outcome Measures :
  1. Major adverse cardiovascular events [ Time Frame: 12 months ]
    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

Secondary Outcome Measures :
  1. Each component of the primary composite endpoint at 12 months [ Time Frame: 12 months ]
  2. In-stent late loss and angiographic pattern of restenosis at 13 months [ Time Frame: 13 months ]
  3. In-sent and in-segment % diameter stenosis (%DS) at 13 months [ Time Frame: 13 months ]
  4. 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 [ Time Frame: 12 months ]
  5. Cost-reducing effect according the duration of duration of anti-platelet therapy [ Time Frame: 12 months ]
  6. Periprocedural myocardial infarction [ Time Frame: 12 months ]
  7. Bleeding defined by Bleeding Academic Research Consortium (BARC) [ Time Frame: 12 months ]
    Bleeding Academic Research Consortium Definition for Bleeding Type 0 to Type 5

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01394848

Korea, Republic of
Yonsei university Wonju College of Medicine
Wonju, Gangwon-do, Korea, Republic of, 220-701
Sponsors and Collaborators
Yonsei University
Yuhan Corporation
Principal Investigator: Seung-Hwan Lee, MD, PhD Yonsi university Wonju college of medicine, Wonju christian hospital

Responsible Party: Seung-Hwan Lee, Professor, Yonsei University Identifier: NCT01394848     History of Changes
Other Study ID Numbers: INNOVATION_v5.0
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Angina, Stable
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Atorvastatin Calcium
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors