Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study

Non-ST-Elevation Myocardial Infarction Clinical Trial

— TAPAS II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01013038
• Other study ID #: 2008B101
• Status: Recruiting
• Phase: Phase 4
• First received: November 6, 2009
• Last updated: November 12, 2009
• Start date: December 2007
• Est. completion date: June 2012

Study information

• Verified date: November 2009
• Source: University Medical Center Groningen
• Contact: Marthe A Kampinga, MD
• Phone: +31503610444
• Email: m.a.kampinga[@]thorax.umcg.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non-ST-Elevation Myocardial Infarction

Intervention

Procedure:
• Thrombus aspiration followed by stent implantation
Export aspiration catheter 6F (Medtronics)
• conventional PCI
balloon angioplasty and/or stent implantation

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Netherlands Heart Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of myocardial blush grade 3 after PCI		During PCI procedure	No
Secondary	Coronary angiographic outcomes		During PCI procedure	No
Secondary	Histopathological outcomes of atherothrombotic material		After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius)	No
Secondary	Enzymatic infarct size		During hospital stay	No
Secondary	Electrocardiographic outcomes		30 to 60 minutes after PCI	No
Secondary	Clinical outcomes at 30 days and 1 year		30 days till 1 year	No