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Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study
ISRCTN ISRCTN16716833
DOI 10.1186/ISRCTN16716833
ClinicalTrials.gov identifier
EudraCT number
Public title Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study
Scientific title Effectiveness of thrombus aspiration compared to balloon angioplasty on myocardial reperfusion during percutaneous coronary intervention in acute myocardial infarction
Acronym TAPAS
Serial number at source NTR914
Study hypothesis Thrombus aspiration compared to balloon angioplasty will improve myocardial reperfusion during primary percutaneous coronary intervention.
Lay summary
Ethics approval Ethics approval received from the local ethics committee.
Study design Randomised, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Myocardial infarction
Participants - inclusion criteria 1. A diagnosis of acute myocardial infarction (MI) defined by chest pain suggestive for myocardial ischaemia for at least 30 minutes, with a time from onset of symptoms of less than 12 hours, before hospital admission
2. An electrocardiogram (ECG) with ST-segment elevation of more than 0.1 mV in two or more leads
Participants - exclusion criteria 1. Rescue percutaneous coronary intervention (PCI) after thrombolytic therapy
2. Inability to obtain informed consent
3. Known existence of a life-threatening disease with a life expectancy of less than six months
Anticipated start date 01/01/2005
Anticipated end date 01/01/2007
Status of trial Completed
Patient information material
Target number of participants 1080
Interventions Thrombus aspiration compared to conventional balloon angioplasty during primary percutaneous coronary intervention. Patients are assigned to treatment with thrombus aspiration with the 6F Export Aspiration Catheter (Medtronic Corporation, Santa Rosa, California, USA) or to balloon angioplasty before stent implantation in the infarct related artery.
Primary outcome measure(s) Angiographic myocardial blush grade of less than two
Secondary outcome measure(s) 1. Enzymatic infarct size
2. ST-segment elevation resolution
3. Persistent ST-segment elevation
4. Post-procedural distal embolisation
5. Major adverse cardiac events at 30 days and one year
Sources of funding University Medical Centre Groningen (UMCG) (The Netherlands)
Trial website
Publications Protocol in:
1. 2006 study design: http://www.ncbi.nlm.nih.gov/pubmed/16504620

Results in:
2. 2008 thrombus aspiration results: http://www.ncbi.nlm.nih.gov/pubmed/18256391
3. 2008 1-year follow-up study results: http://www.ncbi.nlm.nih.gov/pubmed/18539223
4. 2009 substudy results in http://www.ncbi.nlm.nih.gov/pubmed/19168868
Contact name Dr  Tone  Svilaas
  Address University Medical Centre Groningen
Thorax Centre
Department of Cardiology
P.O. Box 30001
  City/town Groningen
  Zip/Postcode 9700 RB
  Country Netherlands
  Tel +31 (0)50 361 0444
  Fax +31 (0)50 361 4391
  Email t.svilaas@thorax.umcg.nl
Sponsor University Medical Centre Groningen (UMCG) (The Netherlands)
  Address Thorax Centre
Department of Cardiology
  City/town Groningen
  Zip/Postcode 9700 RB
  Country Netherlands
  Sponsor website: http://www.umcg.nl/azg/nl/english/azg/#http://www.umcg.nl/azg/nl/english/azg/
Date applied 07/03/2007
Last edited 27/01/2009
Date ISRCTN assigned 07/03/2007
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