Overview

This trial is active, not recruiting.

Condition non-st-elevation myocardial infarction
Treatments thrombectomy, standard percutaneous coronary intervention
Phase phase 4
Sponsor University of Leipzig
Start date March 2011
End date June 2013
Trial size 400 participants
Trial identifier NCT01612312, 070-11-07032011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
(Other)
In the standard percutaneous coronary intervention (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.

Primary Outcomes

Measure
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

Measure
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
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)

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)
Principal investigator Holger Thiele, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Leipzig.