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

This study has been terminated.
(Previous other study including EPC capture stent raised the issue of safety (significant high incidence of instent restenosis))
Sponsor:
Collaborators:
OrbusNeich
Yuhan Corporation
Information provided by (Responsible Party):
Seung-Hwan Lee, Yonsei University
ClinicalTrials.gov Identifier:
NCT01394848
First received: July 11, 2011
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Major adverse cardiovascular events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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:
  • Each component of the primary composite endpoint at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • In-stent late loss and angiographic pattern of restenosis at 13 months [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
  • In-sent and in-segment % diameter stenosis (%DS) at 13 months [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Cost-reducing effect according the duration of duration of anti-platelet therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Periprocedural myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Bleeding defined by Bleeding Academic Research Consortium (BARC) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Bleeding Academic Research Consortium Definition for Bleeding Type 0 to Type 5


Enrollment: 1
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394848

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

No publications provided

Responsible Party: Seung-Hwan Lee, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01394848     History of Changes
Other Study ID Numbers: INNOVATION_v5.0
Study First Received: July 11, 2011
Last Updated: December 3, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Angina, Stable
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Everolimus
Sirolimus
Atorvastatin
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 31, 2014