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

Phase 4

Completed

• Conditions: Non-ST-elevation Myocardial Infarction

• Registration Number: NCT01612312
• Lead Sponsor: University of Leipzig

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-06-01
• Study First Posted: 2012-06-05
• Primary Completion: 2013-06
• Study Completion: 2016-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR)	CMR performed within day 1 to 4 after randomization

Secondary Outcome Measures

Name	Time	Method
Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR)	CMR performed within day 1 to 4 after randomization
Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR)	CMR performed within day 1 to 4 after randomization
Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI	Immediately after percutaneous coronary intervention
Combined clinical endpoint	Follow-up performed at 6, 12 and approximately 60 months after randomization	Occurence of a combined clinical endpoint including death, re-infarction, target vessel revascularization and congestive heart failure will be recorded. Clinical outcome will be assessed by a telephone interview at 6 and 12 months. Any clinical event will be verified by hospital or general practitioner records.
Assessment of quality of life	6, 12 and approximately 60 months after randomization
Myocardial blush grade	Immediately after percutaneous coronary intervention
Infarct size assessed by cardiac magnetic resonance imaging (CMR)	CMR performed within day 1 to 4 after randomization
Stroke and bleeding	Participants will be followed for the duration of hospital stay (an expected average of 5 days)
Troponin T	24 and 48 hours after randomization

Trial Locations

Locations (7)

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