Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)

NCT ID: NCT01612312

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-10-31

Brief Summary

Whereas thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI) is recommended by current guidelines, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI). The Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI) trial is a 400 patient, prospective, controlled, multicenter, randomized, open-label trial. The hypothesis is that under the background of early revascularization, adjunctive thrombectomy in comparison to conventional percutaneous coronary intervention (PCI) alone leads to less microvascular obstruction (MO) assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of MO assessed by CMR. Secondary endpoints include infarct size and myocardial salvage assessed by CMR, enzymatic infarct size as well as angiographic parameters, such as Thrombolysis in Myocardial Infarction-flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial reinfarction, target vessel revascularization and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by bleeding and stroke. In summary, the TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI.

Conditions

Non-ST-elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Thrombectomy

Group Type: ACTIVE_COMPARATOR

Thrombectomy

Intervention Type: PROCEDURE

Manual thrombectomy will be performed in the thrombus aspiration group using an aspiration catheter utilized in daily clinical routine (Eliminate, Terumo Europe, Leuven, Belgium). In the standard PCI group, patients will be treated by conventional PCI according to local practice without thrombectomy.

Standard percutaneous coronary intervention

In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.

Group Type: OTHER

Standard percutaneous coronary intervention

Intervention Type: PROCEDURE

In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.

Interventions

Thrombectomy

Manual thrombectomy will be performed in the thrombus aspiration group using an aspiration catheter utilized in daily clinical routine (Eliminate, Terumo Europe, Leuven, Belgium). In the standard PCI group, patients will be treated by conventional PCI according to local practice without thrombectomy.

Intervention Type: PROCEDURE

Standard percutaneous coronary intervention

In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ischemic symptoms such as angina pectoris >20 minutes
• occurrence of last symptoms <72 h before randomization
• cardiac troponin T or I levels above the 99th percentile
• culprit lesion containing thrombus (TIMI-thrombus grade 2-5 within the lesion) and intended early PCI

Exclusion Criteria

• cardiogenic shock
• STEMI
• no identifiable culprit lesion or a TIMI-thrombus grade <2
• coronary morphology ineligible for thrombectomy (e.g. very tortuous vessels, severe calcification)
• indication for acute bypass surgery
• age <18 and >90 years
• contraindications for treatment with heparin, aspirin or thienopyridines
• pregnancy
• current participation in another clinical study
• co-morbidity with limited life expectancy <6 months
• contraindications to CMR at study entry

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Holger Thiele

Co-Director, Department of Internal Medicine/Cardiology, Heart Center Leipzig, University of Leipzig, Germany

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holger Thiele, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig, University of Leipzig, Germany

Locations

Zentralklinik Bad Berka

Bad Berka, , Germany

Unfallkrankenhaus Berlin

Berlin, , Germany

Klinikum Frankfurt/Oder

Frankfurt (Oder), , Germany

University of Saarland, Campus Homburg/Saar

Homburg, , Germany

University of Leipzig

Leipzig, , Germany

Institut für Herzinfarktforschung

Ludwigshafen, , Germany

University of Tübingen

Tübingen, , Germany

Countries

Germany

References

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Other Identifiers

070-11-07032011

Identifier Type: -

Identifier Source: org_study_id