Condition category
Circulatory System
Date applied
07/03/2007
Date assigned
07/03/2007
Last edited
27/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tone Svilaas

ORCID ID

Contact details

University Medical Centre Groningen
Thorax Centre
Department of Cardiology
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 361 0444
t.svilaas@thorax.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR914

Study information

Scientific title

Effectiveness of thrombus aspiration compared to balloon angioplasty on myocardial reperfusion during percutaneous coronary intervention in acute myocardial infarction

Acronym

TAPAS

Study hypothesis

Thrombus aspiration compared to balloon angioplasty will improve myocardial reperfusion during primary percutaneous coronary intervention.

Ethics approval

Ethics approval received from the local ethics committee.

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Myocardial infarction

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Angiographic myocardial blush grade of less than two

Secondary outcome measures

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

Overall trial start date

01/01/2005

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1080

Participant 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

Recruitment start date

01/01/2005

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen (UMCG) (The Netherlands)

Sponsor details

Thorax Centre
Department of Cardiology
Groningen
9700 RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl/azg/nl/english/azg/#http://www.umcg.nl/azg/nl/english/azg/

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Groningen (UMCG) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Study design

    Svilaas T, van der Horst IC, Zijlstra F, Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS)--study design., Am. Heart J., 2006, 151, 3, 597.e1-597.e7, doi: 10.1016/j.ahj.2005.11.010.

  2. Thrombus aspiration results

    Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F, Thrombus aspiration during primary percutaneous coronary intervention., N. Engl. J. Med., 2008, 358, 6, 557-567, doi: 10.1056/NEJMoa0706416.

  3. Substudy results

    Vogelzang M, Vlaar PJ, Svilaas T, Amo D, Nijsten MW, Zijlstra F, Computer-assisted myocardial blush quantification after percutaneous coronary angioplasty for acute myocardial infarction: a substudy from the TAPAS trial., Eur. Heart J., 2009, 30, 5, 594-599, doi: 10.1093/eurheartj/ehn542.

  4. Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F, Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study., Lancet, 2008, 371, 9628, 1915-1920, doi: 10.1016/S0140-6736(08)60833-8.

Additional files

Editorial Notes