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SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries (SYNTAX)

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ClinicalTrials.gov Identifier: NCT00114972
Recruitment Status : Unknown
Verified May 2010 by Boston Scientific Corporation.
Recruitment status was:  Active, not recruiting
First Posted : June 21, 2005
Results First Posted : June 23, 2010
Last Update Posted : June 23, 2010
Sponsor:
Collaborator:
Cardialysis BV
Information provided by:
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE June 20, 2005
First Posted Date  ICMJE June 21, 2005
Results First Submitted Date March 27, 2009
Results First Posted Date June 23, 2010
Last Update Posted Date June 23, 2010
Study Start Date  ICMJE March 2005
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2010)
  • Primary Clinical Endpoint of 12-Month Binary MACCE. [ Time Frame: 12 months post enrollment ]
    Number of participants at primary clinical endpoint of 12-Month binary MACCE. MACCE is defined as: all cause death, cerebrovascular event (stroke), cocumented myocardial infarction, repeat revascularization (PCI and/or CABG).
  • 12-month Composite Safety Endpoint. [ Time Frame: 12 months after enrollment ]
    Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.
  • Repeat Revascularization (PCI and/or CABG). [ Time Frame: 12 Months post enrollment ]
    Number of participants with repeat revascularization (PCI and/or CABG).
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • 12-month MACCE rate. MACCE is defined as:
  • *all cause death
  • *cerebrovascular event (such as stroke)
  • *documented myocardial infarction
  • *repeat revascularization (PCI and/or CABG)
Change History Complete list of historical versions of study NCT00114972 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2010)
  • Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation. [ Time Frame: 1 month after procedure and 6 months, 3 years, and 5 years post allocation ]
    Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.
  • Individual Components of MACCE at 1 Month Post-procedure. [ Time Frame: 1 month after procedure ]
    Number of participants with individual components of MACCE at 1 month post-procedure. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.
  • Individual Components of MACCE at 6 Months Post-allocation. [ Time Frame: 6 months post allocation ]
    Number of participants with individual components of MACCE at 6 months post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.
  • Individual Components of MACCE at 1 Year Post-allocation. [ Time Frame: 1 year post allocation ]
    Number of participants with individual components of MACCE at 1 year post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.
  • Freedom From MACCE and Its Components at 1 Year Post-allocation. [ Time Frame: 1 year post allocation ]
    Number of participants with freedom from MACCE and its components at 1 year post-allocation. Freedom from MACCE is defined as no MACCE nor any of the individual components of MACCE (all cause death, stroke, documented myocardial infarction, repeat revascularization).
  • Freedom From MACCE and Its Components at 3 Years Post-allocation [ Time Frame: 3 years post allocation ]
  • Freedom From MACCE and Its Components at 5 Years Post-allocation [ Time Frame: 5 years post allocation ]
  • Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation [ Time Frame: 1 month after procedure and 6 months, 1, 3 and 5 years post allocation ]
  • Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation [ Time Frame: 1 year, 3 and 5 years post allocation ]
  • The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible) [ Time Frame: 5 Years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Overall MACCE rate at 1 month post-procedure and at 6 months, 3 and 5 years post-allocation
  • Rates of the individual components of MACCE at 1 month post-procedure and at 6 months, 1, 3 and 5 years post-allocation
  • Freedom from MACCE and its components at 1, 3 and 5 years post-allocation
  • Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation
  • Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation
  • The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible)
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
Official Title  ICMJE SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery
Brief Summary The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either percutaneous coronary intervention (PCI) with polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).
Detailed Description

Due to the introduction of drug-eluting stents (DESs) and to improvements in therapy for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) patients, PCI is challenging CABG as the gold standard for treatment of three vessel (3VD) and left main (LM) coronary disease.

SYNTAX is a novel, randomized trial with nested registries comparing PCI with paclitaxel-eluting TAXUS stents to CABG for 3VD and LM patients to evaluate the best treatment for these patients with complex coronary disease.

Patients at participating centers will be evaluated by both a cardiothoracic surgeon and by an interventional cardiologist.

Those patients who are determined to be eligible for treatment by both PCI and CABG will be randomized to receive either PCI with a polymer-based paclitaxel-eluting TAXUS stent or CABG.

Patients who are determined to be unsuitable for treatment by PCI will be treated by CABG and will be entered into a CABG registry to help define the patient population in which stenting continues to be an unacceptable treatment option.

Similarly, patients who are determined to be unsuitable for treatment by CABG will be treated by PCI, using any interventional techniques or devices with or without the use of DES, and entered into a PCI registry to help define the patients for whom CABG is considered inappropriate.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
    Drug Eluting Stent
    Other Names:
    • Percutaneous coronary intervention
    • Paclitaxel eluting stent
    • 3 vessel disease
    • Left main stem
  • Procedure: Coronary Artery Bypass Surgery
    Coronary Artery Bypass Surgery
    Other Names:
    • Coronary artery disease
    • Coronary artery bypass graft
    • Left Main coronary artery
Study Arms
  • Experimental: PCI with DES
    Intervention: Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
  • Active Comparator: CABG (coronary artery bypass graft)
    Coronary Artery Bypass Graft
    Intervention: Procedure: Coronary Artery Bypass Surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: February 22, 2006)
1800
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
1500
Estimated Study Completion Date May 2012
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Three-vessel disease, left main disease or LM equivalent with or without 1, 2 or 3VD (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory)
  • De novo lesions with at least 50% stenosis
  • Myocardial ischemia (stable, unstable, silent)

Exclusion Criteria:

  • Prior PCI or CABG
  • Acute myocardial infarction (with creatinine kinase >2x upper limit of normal)
  • Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement)
  • Participation or planned participation in another cardiovascular clinical study before 1 year follow-up is completed
  • Inability to give informed consent due to mental condition, mental retardation, or language barrier
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Italy,   Latvia,   Netherlands,   Norway,   Poland,   Portugal,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00114972
Other Study ID Numbers  ICMJE S2024
90169394
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nic Van Dyck, Boston Scientific
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Cardialysis BV
Investigators  ICMJE
Principal Investigator: Patrick W. Serruys, MD, PhD Erasmus University Medical Center Rotterdam
Principal Investigator: Friedrich W Mohr, MD Heart Center Leipzig - University Hospital
Study Director: Monika Hanisch, PhD Boston Scientific Corporation
PRS Account Boston Scientific Corporation
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP