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Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01013038
Recruitment Status : Unknown
Verified November 2009 by University Medical Center Groningen.
Recruitment status was:  Recruiting
First Posted : November 13, 2009
Last Update Posted : November 13, 2009
Sponsor:
Collaborator:
Netherlands Heart Foundation
Information provided by:
University Medical Center Groningen

Tracking Information
First Submitted Date  ICMJE November 6, 2009
First Posted Date  ICMJE November 13, 2009
Last Update Posted Date November 13, 2009
Study Start Date  ICMJE December 2007
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2009)
Incidence of myocardial blush grade 3 after PCI [ Time Frame: During PCI procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2009)
  • Coronary angiographic outcomes [ Time Frame: During PCI procedure ]
  • Histopathological outcomes of atherothrombotic material [ Time Frame: After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius) ]
  • Enzymatic infarct size [ Time Frame: During hospital stay ]
  • Electrocardiographic outcomes [ Time Frame: 30 to 60 minutes after PCI ]
  • Clinical outcomes at 30 days and 1 year [ Time Frame: 30 days till 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study
Official Title  ICMJE Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)
Brief Summary In this trial, the investigators will evaluate the effect of thrombus aspiration followed by stent implantation in improving myocardial blush grade in patients with acute non-ST-elevation myocardial infarction compared to conventional percutaneous coronary intervention (PCI).
Detailed Description

The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) has shown that thrombus aspiration improves myocardial perfusion and clinical outcome compared to conventional primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction. Impaired myocardial perfusion due to spontaneous or angioplasty-induced embolization of atherothrombotic material also occurs in patients with Non-ST-elevation myocardial infarction (NSTEMI). The aim of this study is to determine whether thrombus aspiration before stent implantation will result in improved myocardial perfusion in patients with NSTEMI compared to conventional PCI.

The study is a single-centre, prospective, randomised trial with blinded evaluation of endpoints. The planned inclusion is 540 patients with acute NSTEMI who are candidates for urgent PCI.

If thrombus aspiration leads to significant improvement of myocardial perfusion in patients with acute NSTEMI it may become part of the standard interventional approach.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non-ST-Elevation Myocardial Infarction
Intervention  ICMJE
  • Procedure: Thrombus aspiration followed by stent implantation
    Export aspiration catheter 6F (Medtronics)
  • Procedure: conventional PCI
    balloon angioplasty and/or stent implantation
Study Arms  ICMJE
  • Active Comparator: Conventional percutaneous coronary intervention
    Intervention: Procedure: conventional PCI
  • Experimental: Thrombus aspiration
    Intervention: Procedure: Thrombus aspiration followed by stent implantation
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: November 12, 2009)
540
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2012
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of acute NSTEMI defined by

    • Chest pain suggestive for myocardial ischemia for at least 30 minutes,
    • Time from onset of symptoms of less than 72 hours
    • ECG with ST-segment shifts (depression of >0.1 mV in at least two contiguous leads or transient ST-segment elevation >0.1 mV in at least two contiguous leads for less than 30 minutes) and/or T-wave changes (inversion of >0.15 mV in at least two contiguous leads)
    • Positive cardiac troponin T >0,01 μg/L.
  • Clinical indication for urgent PCI of the ischemia-related target lesion as identified at coronary angiography

Exclusion Criteria:

  • Persistent ST-elevation of more than 0.1 mV in 2 or more leads
  • Presence of cardiogenic shock
  • Inability to obtain informed consent
  • Known existence of a life-threatening disease with a life expectancy of less than 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01013038
Other Study ID Numbers  ICMJE 2008B101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marthe Anna Kampinga, MD & Felix Zijlstra, MD PhD, University Medical Center Groningen, Thoraxcenter
Study Sponsor  ICMJE University Medical Center Groningen
Collaborators  ICMJE Netherlands Heart Foundation
Investigators  ICMJE Not Provided
PRS Account University Medical Center Groningen
Verification Date November 2009

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