Polish-Italian-Hungarian RAndomized ThrombEctomy Trial

NCT ID: NCT00377650

Last Updated: 2007-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-12-31

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

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Percutaneous thrombectomy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Principal Investigators

Dariusz Dudek, MD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Locations

Institute, Medical School of University Pecs

Pécs, , Hungary

Site Status: RECRUITING

Cardiology Department Hospital Villascassi

Genova, , Italy

Site Status: RECRUITING

Institute of Cardiology, Catholic University

Rome, , Italy

Site Status: RECRUITING

Górnośląskie Centrum Medyczne

Katowice, , Poland

Site Status: RECRUITING

Zaklad Hemodynamiki i Angiokardiohrafii IK CMUJ

Krakow, , Poland

Site Status: RECRUITING

Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ

Nowy Sącz, , Poland

Site Status: RECRUITING

Szpital Wojewódzki w Przemyślu

Przemyśl, , Poland

Site Status: RECRUITING

Instytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala Wyszynskiego

Warsaw, , Poland

Site Status: RECRUITING

Slaskie Centrum Chorob Serca

Zabrze, , Poland

Site Status: RECRUITING

Countries

Hungary; Italy; Poland

Central Contacts

Dariusz Dudek, MD

Role: CONTACT

mcdudek@cyf-kr.edu.pl

124247181 ext. +48

Facility Contacts

Ivan Horvath, MD

Role: primary

ivan.g.horvath@aok.pte.hu

Paolo Rubartelli, MD

Role: primary

paolo.rubartelli@villascassi.it

Francesco Burzotta, MD

Role: primary

f.burzotta@rm.unicatt.it

Andrzej Ochala, Md

Role: primary

aochala@poczta.onet.pl

Waldemar A Mielecki, MD

Role: primary

wmielecki@su.krakow.pl

124247181 ext. +48

Renata Korpak-Wysocka, MD

Role: primary

184407487 ext. +48

Andrzej Wiśniewski, MD

Role: primary

166775000 ext. +48

Adam Witkowski, MD

Role: primary

witkowski@hbz.pl

Mariusz Gasior, MD

Role: primary

m.gasior@sccs.pl

References

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.

Reference Type: DERIVED

PMID: 21095287 (View on PubMed)

Other Identifiers

JagiellonianU

Identifier Type: -

Identifier Source: org_study_id