Skip to main content
OpenTrials
Completed

NCT Number: NCT01612312

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zentralklinik Bad Berka, Bad Berka, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thrombectomy

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

Procedure

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

Primary outcomes

  1. Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR)

    Time frame: CMR performed within day 1 to 4 after randomization

Secondary outcomes

  1. Infarct size assessed by cardiac magnetic resonance imaging (CMR)

    Time frame: CMR performed within day 1 to 4 after randomization

  2. Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR)

    Time frame: CMR performed within day 1 to 4 after randomization

  3. Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR)

    Time frame: CMR performed within day 1 to 4 after randomization

  4. Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI

    Time frame: Immediately after percutaneous coronary intervention

  5. Myocardial blush grade

    Time frame: Immediately after percutaneous coronary intervention

  6. Troponin T

    Time frame: 24 and 48 hours after randomization

  7. Combined clinical endpoint

    Time frame: 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.

  8. Assessment of quality of life

    Time frame: 6, 12 and approximately 60 months after randomization

  9. Stroke and bleeding

    Time frame: Participants will be followed for the duration of hospital stay (an expected average of 5 days)

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2016
First posted
Jun 5, 2012
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.