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

NCT01394848 | Terminated Phase 4 DMC

• 1 other identifier: INNOVATION_v5.0
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Each component of the primary composite endpoint at 12 months

  12 months

• In-stent late loss and angiographic pattern of restenosis at 13 months

  13 months

• In-sent and in-segment % diameter stenosis (%DS) at 13 months

  13 months

• 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

• Cost-reducing effect according the duration of duration of anti-platelet therapy

  12 months

Study Arms (4)

Genous stent group

ACTIVE COMPARATOR

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

Xience stent group

ACTIVE COMPARATOR

Xience Prime V stent (everolimus eluting stent) insertion in elderly patients with stable coronary artery disease

Device: Everolimus eluting stent with 12 month clopidogrel

Atorvastatin 20mg group

ACTIVE COMPARATOR

Drug: Atorvastatin 20mg loading

Atorvastatin 80mg group

ACTIVE COMPARATOR

Drug: Atorvastatin 80mg loading

Interventions

Endothelial cell capture stent with 1 month clopidogrel DEVICE

75mg PO clopidogrel per day for 1 months

Also known as: Genous stent

Genous stent group

Everolimus eluting stent with 12 month clopidogrel DEVICE

75mg PO clopidogrel per day for over 12 months

Also known as: Xience stent

Xience stent group

Atorvastatin 20mg loading DRUG

Atorvastatin 20mg loading before index percutaneous coronary intervention

Also known as: Atorvastatin

Atorvastatin 20mg group

Atorvastatin 80mg loading DRUG

Atorvastatin 80mg loading before index percutaneous coronary intervention

Also known as: Atorvastatin

Atorvastatin 80mg group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead
• OrbusNeich: collaborator
• Yuhan Corporation: collaborator

Study Sites (1)

Yonsei university Wonju College of Medicine

Wŏnju, Gangwon-do, 220-701, South Korea

Location

MeSH Terms

Conditions

Angina, Stable

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Seung-Hwan Lee, MD, PhD

  Yonsi university Wonju college of medicine, Wonju christian hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 14, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

KR (1)