Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study

ISRCTN	ISRCTN16716833
DOI	https://doi.org/10.1186/ISRCTN16716833
Protocol serial number	NTR914
Sponsor	University Medical Centre Groningen (UMCG) (The Netherlands)
Funder	University Medical Centre Groningen (UMCG) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Tone Svilaas
Scientific

University Medical Centre Groningen
Thorax Centre
Department of Cardiology
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 361 0444
Email	t.svilaas@thorax.umcg.nl

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Effectiveness of thrombus aspiration compared to balloon angioplasty on myocardial reperfusion during percutaneous coronary intervention in acute myocardial infarction
Study acronym	TAPAS
Study objectives	Thrombus aspiration compared to balloon angioplasty will improve myocardial reperfusion during primary percutaneous coronary intervention.
Ethics approval(s)	Ethics approval received from the local ethics committee.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Angiographic myocardial blush grade of less than two
Key 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
Completion date	01/01/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1080
Key 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
Key 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
Date of first enrolment	01/01/2005
Date of final enrolment	01/01/2007

University Medical Centre Groningen

Groningen
9700 RB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	thrombus aspiration results:	07/02/2008	Yes	No
Results article	1-year follow-up study results:	07/06/2008	Yes	No
Results article	substudy results	01/03/2009	Yes	No
Other publications	study design:	01/03/2006	Yes	No