Complete Lesion Versus Culprit Lesion Revascularization (COCUA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Korea University Guro Hospital
Sponsor:
Information provided by (Responsible Party):
Seung Woon Rha, Korea University Guro Hospital
ClinicalTrials.gov Identifier:
NCT01180218
First received: August 10, 2010
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

To investigate the clinical outcomes of acute myocardial infarction (AMI) patients with multivessel disease undergoing percutaneous coronary intervention (PCI) either in infarct-related artery only or in multivessel in Drug eluting stents (DES) era, using the everolimus-eluting stent (Promus™ Element™ Stent, Boston Scientific) in real-world clinical practice.


Condition Intervention Phase
Myocardial Infarction
Procedure: complete revascularization
Procedure: Culprit revasularization
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Complete Lesion Versus Culprit Lesion Revascularization in Acute ST Elevation Myocardial Infarction Patients With Multivessel Disease Undergoing Primary Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Korea University Guro Hospital:

Primary Outcome Measures:
  • target vessel related major adverse cardiac events [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Cardiac death, ST elevation myocardiac infarction (STEMI), Ischemic driven target lesion revascularization (TLR) .


Secondary Outcome Measures:
  • total major cardiac adverse events [ Time Frame: one years ] [ Designated as safety issue: Yes ]
    1. All death including cardiac and non cardiac death
    2. Recurrent MI or any MI (STEMI or NSTEMI)
    3. Any revascularizations (TLR or TVR)
    4. Dye nephropathy, Procedure time, Complication (puncture site hematoma, bleeding)
    5. In hospital complication
    6. Composite rate of cardiac death and any MI
    7. Composite rate of all death and any MI
    8. Composite rate of all death, any MI and any repeat revascularization


Estimated Enrollment: 646
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: complete revascularization
Complete revascularization (CR): This group comprises the patients who undergo a one-time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions
Procedure: complete revascularization
-Complete revascularization : one time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions in patient with ST elevateion myocardial infarction (STEMI) and multivessle disease
Active Comparator: Culprit revascularization
Culprit only revascularization (COR): This group comprises the patients who undergo PCI of only the culprit lesion and staged nonculprit PCI at a later date.
Procedure: Culprit revasularization
Culprit revascularization : PCI of only the culprit lesion and staged nonculprit PCI at a later date in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must be at least 18 years of age.
  • Subject is able to verbally confirm understandings of risks, benefits and treatment of culprit or complete revascularization using everolimus eluting coronary stent (Promus™ Element™ Stent) and he or she or his or her legally authorized representative provides written informed consent prior to any study related procedure.
  • Subject must have significant more than two target lesions and requiring primary PCI for acute ST elevation myocardial infarction (STEMI) within 48hrs
  • Target lesion(s) must be located in a native coronary artery with visually estimated diameter of less than 2.5 mm and more than 4.0 mm.
  • Target lesion(s) must be amenable for percutaneous coronary intervention

Exclusion Criteria:

  • The patient has a known hypersensitivity or contraindication to any of the following medications:

Heparin Aspirin Both Clopidogrel and Ticlopidine Everolimus Platinum chromium Contrast media

  • Patients with documented sensitivity to contrast media which can be effectively pre medicated 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. 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- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months,induced thrombocytopenia), or will refuse blood transfusions.
  • An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.
  • Non-cardiac comorbid conditions are present with life expectancy over 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.
  • Patients with more than 25 percentage of LVEF or those with cardiogenic shock
  • Creatinine level more than 3mg per dL or dependence on dialysis.
  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: NCT01180218

Contacts
Contact: Seung Woon Rha 82-2-2626-3020 swrha617@yahoo.co.kr
Contact: Ji Young Park 82-2-970-8620 cisamoe@gmail.com

Locations
Korea, Republic of
Seung Woon Rha Recruiting
Seoul, Korea, Republic of
Contact: Seung Woon Rha, MD,PhD    82-2626-3020    swrha@yahoo.co.kr   
Principal Investigator: Seung Woon Rha, MD,PhD         
Sponsors and Collaborators
Korea University Guro Hospital
Investigators
Principal Investigator: Seung Woon Rha professor
  More Information

Publications:
Responsible Party: Seung Woon Rha, Associate professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT01180218     History of Changes
Other Study ID Numbers: KoreaUGuroH_1
Study First Received: August 10, 2010
Last Updated: January 28, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Korea University Guro Hospital:
myocardial revascularization
myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014