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

This study is currently recruiting participants.
Verified August 2013 by University of Leipzig
Sponsor:
Information provided by (Responsible Party):
Holger Thiele, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01612312
First received: May 30, 2012
Last updated: August 19, 2013
Last verified: August 2013

May 30, 2012
August 19, 2013
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ] [ Designated as safety issue: No ]
  • Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ] [ Designated as safety issue: No ]
  • Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI [ Time Frame: Immediately after percutaneous coronary intervention ] [ Designated as safety issue: No ]
  • Myocardial blush grade [ Time Frame: Immediately after percutaneous coronary intervention ] [ Designated as safety issue: No ]
  • Troponin T [ Time Frame: 24 and 48 hours after randomization ] [ Designated as safety issue: No ]
  • Combined clinical endpoint [ Time Frame: Follow-up performed at 6 and 12 months after randomization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Stroke and bleeding [ Time Frame: Participants will be followed for the duration of hospital stay (an expected average of 5 days) ] [ Designated as safety issue: Yes ]
Same as current
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
de Waha S, Eitel I, Desch S, Scheller B, Böhm M, Lauer B, Gawaz M, Geisler T, Gunkel O, Bruch L, Klein N, Pfeiffer D, Schuler G, Zeymer U, Thiele H. Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial. Trials. 2013 Apr 25;14:110. doi: 10.1186/1745-6215-14-110.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
October 2013
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
Both
18 Years to 90 Years
No
Contact: Holger Thiele, MD + 49 341 865 1427 thielh@medizin.uni-leipzig.de
Germany
 
NCT01612312
070-11-07032011
Yes
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
August 2013

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