Non-ST-Elevation Myocardial InfarctionPhase 4TAPAS IINCT01013038
Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study
A Phase 4 study testing Thrombus aspiration followed by stent implantation and conventional PCI in people with Non-ST-Elevation Myocardial Infarction, run by University Medical Center Groningen at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ST-Elevation Myocardial Infarction
- What is being tested?
- Thrombus aspiration followed by stent implantation and conventional PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2007to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen
Marthe A Kampinga, MD, +31503610444, m.a.kampinga@thorax.umcg.nl
About this study
Official title: Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)
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).
Read the 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.
- Conditions
- Non-ST-Elevation Myocardial Infarction
- Being tested
- Thrombus aspiration followed by stent implantation, conventional PCI
- Keywords
- myocardial infarction, percutaneous coronary intervention, thrombus aspiration
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombus aspiration followed by stent implantationProcedure or surgery
Export aspiration catheter 6F (Medtronics)
conventional PCIProcedure or surgery
balloon angioplasty and/or stent implantation
| Study group | Role | What they receive |
|---|---|---|
| Conventional percutaneous coronary intervention | Active comparator | Not described Receives: Procedure: conventional PCI |
| Thrombus aspiration | Experimental | Not described Receives: Procedure: Thrombus aspiration followed by stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of myocardial blush grade 3 after PCI
Measured: During PCI procedure
Secondary outcomes (5)
Coronary angiographic outcomes
Measured: During PCI procedure
Histopathological outcomes of atherothrombotic material
Measured: After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius)
Enzymatic infarct size
Measured: During hospital stay
Electrocardiographic outcomes
Measured: 30 to 60 minutes after PCI
Clinical outcomes at 30 days and 1 year
Measured: 30 days till 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startDec 2007
- Primary completionJun 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST-Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Heart Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013038
- Sponsor's protocol ID
- 2008B101
- Acronym
- TAPAS II
- Status last verified
- Nov 2009
- First submitted
- 6 Nov 2009
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)
- ClinicalTrials.gov ID
- NCT01013038
- Acronym / sponsor ID
- TAPAS II / 2008B101
- Conditions
- Non-ST-Elevation Myocardial Infarction
- Keywords
- myocardial infarction, percutaneous coronary intervention, thrombus aspiration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Study start
- Dec 2007
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional percutaneous coronary intervention | Active comparator | Procedure: conventional PCI |
| Thrombus aspiration | Experimental | Procedure: Thrombus aspiration followed by stent implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of acute NSTEMI defined by
- Clinical indication for urgent PCI of the ischemia-related target lesion as identified at coronary angiography
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombus aspiration followed by stent implantationExport aspiration catheter 6F (Medtronics) | Procedure or surgery | Thrombus aspiration |
| conventional PCIballoon angioplasty and/or stent implantation | Procedure or surgery | Conventional percutaneous coronary intervention |
Primary outcome
Incidence of myocardial blush grade 3 after PCI
Time frame: During PCI procedure
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thrombus aspiration followed by stent implantation and conventional PCI in people with Non-ST-Elevation Myocardial Infarction, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marthe A Kampinga, MD (+31503610444, m.a.kampinga@thorax.umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of myocardial blush grade 3 after PCI (time frame: During PCI procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2009.