Clinical trial NCT00377650: Polish-Italian-Hungarian RAndomized ThrombEctomy Trial
Official title: Polish-Italian-Hungarian RAndomized ThrombEctomy Trial. PIHRATE Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myocardial Infarction
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2006-09-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim Primary percutaneous coronary intervention efficacy improvement by DIVER CE thrombectomy system leading to thrombus reduction.

Study design:

Multicenter, prospective, opened, randomized.

Primary endpoints:

ST resolution \>70% 60 minutes after PCI

Secondary endpoints:

Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1 TIMI 3 flow after PCI MBG 3 CMR - infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF) ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI) Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up Rate of composite angiographic adverse events including: distal embolisation, transient no-reflow or slow flow, final TIMI \<3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside, final thrombus score \>1


Eligibility criteria: Inclusion Criteria:

* ST elevation acute myocardial infarction within 6 hours since pain onset, with 2 mm ST segment elevation in two lead
* Minimum 3 mm ST segment elevation in one leads
* Vessel reference diameter \> 2.5 mm
* When vessel reference diameter ≥ 4,0 mm than additional distal protection device (filter) is needed during stent implantation

Exclusion Criteria:

* Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors
* Active bleeding or coagutopathy
* Prior CABG or PCI
* Known ejection fraction EF \<35%
* Cardiogenic shock /SBP \< 90 mmHg, IABP and/or catheloamins usage/
* LBBB, pacemaker rhythm
* Severe calcifications
* Previous Myocardial infarction
* Stroke history
* Patient directly after reanimation
* Known thrombocytopenia- platelets \< 100 000
* Pregnancy
* Cancer disease
* No future patient cooperation expected
* Patient's taking part in the other clinical trials
* Fibrynolisis directly administered before PCI
* Renal insufficiency (creatynine \> 220 µmol/ml), hemodialysis
* Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors
* Active bleeding or coagutopathy
* Prior CABG or PCI
* Known ejection fraction EF \<35%
* Cardiogenic shock /SBP \< 90 mmHg, IABP and/or catheloamins usage/
* LBBB, pacemaker rhythm
* Severe calcifications
* Previous Myocardial infarction
* Stroke history
* Patient directly after reanimation
* Known thrombocytopenia- platelets \< 100 000
* Pregnancy
* Cancer disease
* No future patient cooperation expected
* Patient's taking part in the other clinical trials
* Fibrynolisis directly administered before PCI
* Renal insufficiency (creatynine \> 220 µmol/ml), hemodialysis
* Liver insufficiency

Primary outcomes:
measure: ST resolution >70% 60 minutes after PCI
Secondary outcomes:
measure: Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1
measure: TIMI 3 flow after PCI
measure: MBG 3
measure: CMR - infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF)
measure: ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI)
measure: Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up
measure: Rate of composite angiographic adverse events including: distal embolisation, transient no-reflow or slow flow, final TIMI <3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside, final thrombus score >1
Other outcomes:
Locations:
city: Pecs
country: Hungary
facility: Institute, Medical School of University Pecs
city: Genova
country: Italy
facility: Cardiology Department Hospital Villascassi
city: Rome
country: Italy
facility: Institute of Cardiology, Catholic University
city: Katowice
country: Poland
facility: Górnośląskie Centrum Medyczne
city: Krakow
country: Poland
facility: Zaklad Hemodynamiki i Angiokardiohrafii IK CMUJ
city: Nowy Sacz
country: Poland
facility: Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ
city: Przemyśl
country: Poland
facility: Szpital Wojewódzki w Przemyślu
city: Warszawa
country: Poland
facility: Instytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala Wyszynskiego
city: Zabrze
country: Poland
facility: Slaskie Centrum Chorob Serca
Study officials:
affiliation: Jagiellonian University
name: Dariusz Dudek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dudek D, Mielecki W, Burzotta F, Gasior M, Witkowski A, Horvath IG, Legutko J, Ochala A, Rubartelli P, Wojdyla RM, Siudak Z, Buchta P, Pregowski J, Aradi D, Machnik A, Hawranek M, Rakowski T, Dziewierz A, Zmudka K. Thrombus aspiration followed by direct stenting: a novel strategy of primary percutaneous coronary intervention in ST-segment elevation myocardial infarction. Results of the Polish-Italian-Hungarian RAndomized ThrombEctomy Trial (PIHRATE Trial). Am Heart J. 2010 Nov;160(5):966-72. doi: 10.1016/j.ahj.2010.07.024.