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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Holger Thiele, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01612312
First received: May 30, 2012
Last updated: May 1, 2017
Last verified: May 2017
May 30, 2012
May 1, 2017
March 2011
June 2013   (Final data collection date for primary outcome measure)
Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ]
Same as current
Complete list of historical versions of study NCT01612312 on ClinicalTrials.gov Archive Site
  • Infarct size assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ]
  • Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ]
  • Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ]
  • Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI [ Time Frame: Immediately after percutaneous coronary intervention ]
  • Myocardial blush grade [ Time Frame: Immediately after percutaneous coronary intervention ]
  • Troponin T [ Time Frame: 24 and 48 hours after randomization ]
  • 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.
  • Assessment of quality of life [ Time Frame: 6, 12 and approximately 60 months after randomization ]
  • Stroke and bleeding [ Time Frame: Participants will be followed for the duration of hospital stay (an expected average of 5 days) ]
  • Infarct size assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ]
  • Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ]
  • Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ]
  • Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI [ Time Frame: Immediately after percutaneous coronary intervention ]
  • Myocardial blush grade [ Time Frame: Immediately after percutaneous coronary intervention ]
  • Troponin T [ Time Frame: 24 and 48 hours after randomization ]
  • Combined clinical endpoint [ Time Frame: Follow-up performed at 6 and 12 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 [ Time Frame: 6 and 12 months after randomization ]
  • Stroke and bleeding [ Time Frame: Participants will be followed for the duration of hospital stay (an expected average of 5 days) ]
Not Provided
Not Provided
 
Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Non-ST-elevation Myocardial Infarction
  • Procedure: 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.
  • 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.
  • Active Comparator: Thrombectomy
    Intervention: Procedure: 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.
    Intervention: Procedure: Standard percutaneous coronary intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
October 2016
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01612312
070-11-07032011
Yes
Not Provided
Not Provided
Not Provided
Holger Thiele, University of Leipzig
University of Leipzig
Not Provided
Principal Investigator: Holger Thiele, MD Heart Center Leipzig, University of Leipzig, Germany
University of Leipzig
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP