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

NCT01394848 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2013-12-04

No results posted yet for this study

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

Interventions

DEVICE

Endothelial cell capture stent with 1 month clopidogrel

75mg PO clopidogrel per day for 1 months

DEVICE

Everolimus eluting stent with 12 month clopidogrel

75mg PO clopidogrel per day for over 12 months

DRUG

Atorvastatin 20mg loading

Atorvastatin 20mg loading before index percutaneous coronary intervention

DRUG

Atorvastatin 80mg loading

Atorvastatin 80mg loading before index percutaneous coronary intervention

Sponsors & Collaborators

  • OrbusNeich

    collaborator INDUSTRY

  • Yuhan Corporation

    collaborator INDUSTRY

  • Yonsei University

    lead OTHER

Principal Investigators

  • Seung-Hwan Lee, MD, PhD · Yonsi university Wonju college of medicine, Wonju christian hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01394848 on ClinicalTrials.gov