NCT00422565

Brief Summary

The trial has the following primary objective: To compare the safety and effectiveness of primary acute MI intervention with ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs. sirolimus-eluting balloon expandable stent (Cordis Johnson \& Johnson, Warren, New Jersey) vs. paclitaxel-eluting stent (Taxus Liberte, Boston Scientific).

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

1.9 years

First QC Date

January 16, 2007

Last Update Submit

December 5, 2022

Conditions

Myocardial Infarction

Keywords

Coronary Artery DiseaseStentMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • The composite of death (all cause-mortality), MI (Q wave and non Q wave) and ischemia-driven target vessel revascularization.

    At 12 months after the index procedure

Secondary Outcomes (9)

  • All-cause Death

    1 month, 6 month, 1 year and thereafter annaully up to 5 years

  • Cardiac death

    1 month, 6 month, 1 year and thereafter annaully up to 5 years

  • Recurrent Myocardial infarction

    1 month, 6 month, 1 year and thereafter annaully up to 5 years

  • Target vessel revascularization (all and ischemia-driven)

    1 month, 6 month, 1 year and thereafter annaully up to 5 years

  • Target lesion revascularization (all and ischemia-driven)

    1 month, 6 month, 1 year and thereafter annaully up to 5 years

  • +4 more secondary outcomes

Study Arms (3)

Endeavor

EXPERIMENTAL

Zotarolimus-eluting stent

Device: Endeavor, Medtronic

Cypher

ACTIVE COMPARATOR

Sirolimus-eluting stent

Device: Cypher, Cordis

Taxus

ACTIVE COMPARATOR

Paclitaxel-eluting stent

Device: Taxus Liberte, Boston Scientific

Interventions

Endeavor, MedtronicDEVICE

Zotarolimus-eluting stent

Also known as: Zotarolimus-eluting stent
Endeavor
Cypher, CordisDEVICE

Sirolimus-eluting stent

Also known as: Sirolimus-eluting stent
Cypher
Taxus Liberte, Boston ScientificDEVICE

Paclitaxel-eluting stent

Also known as: Paclitaxel-eluting stent
Taxus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be at least 18 years of age.
  • Culprit de novo lesion in a native coronary artery with significant stenosis (\>50% by visual estimate) eligible for stent implantation (no limitation on stent length)
  • Prolonged, continuous (≥ 20 min) chest pain despite nitrate and: (1) at least 1mm ST-segment elevation in at least 2 leads or reciprocal ST-segment depression ≥ 2 contiguous precordial leads, or (2) newly developed left bundle branch block
  • Symptoms \< 12 hours
  • The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

You may not qualify if:

  • The patient has a known hypersensitivity or contraindication to any of the following medications:
  • Heparin
  • Aspirin
  • Both Clopidogrel and TIclopidine
  • Sirolimus, paclitaxel, ABT 578
  • Stainless steel and/or
  • Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
  • Systemic (intravenous) Sirolimus, paclitaxel or ABT-578 use within 12 months.
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
  • Fibrinolytic therapy for current MI treatment
  • Previous coronary intervention on target vessel
  • 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.
  • Previously documented LVEF \<30%.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Asan Medical Center

Gangneung, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

NHIC Ilsan Hospital

Ilsan, South Korea

Location

Pusan Natioanal University Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, 138-732, South Korea

Location

Korea University Hospital

Seoul, South Korea

Location

St. Mary's Catholic Medical Center

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Yonsei University Wonju Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Myocardial InfarctionCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Seung-Jung Park, MD, PhD

    Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center

Study Record Dates

First Submitted

January 16, 2007

First Posted

January 17, 2007

Study Start

October 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations

KR(12)