Polish-Italian-Hungarian RAndomized ThrombEctomy Trial

Myocardial Infarction Clinical Trial

Official title:

Polish-Italian-Hungarian RAndomized ThrombEctomy Trial. PIHRATE Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00377650
• Other study ID #: JagiellonianU
• Status: Recruiting
• Phase: Phase 4
• First received: September 14, 2006
• Last updated: January 16, 2007
• Start date: September 2005
• Est. completion date: December 2007

Study information

• Verified date: January 2007
• Source: Jagiellonian University
• Contact: Dariusz Dudek, MD
• Phone: 124247181
• Email: mcdudek[@]cyf-kr.edu.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Infarction

Intervention

Device:
• Percutaneous thrombectomy

Locations

Country	Name	City	State
Hungary	Institute, Medical School of University Pecs	Pecs
Italy	Cardiology Department Hospital Villascassi	Genova
Italy	Institute of Cardiology, Catholic University	Rome
Poland	Górnoslaskie Centrum Medyczne	Katowice
Poland	Zaklad Hemodynamiki i Angiokardiohrafii IK CMUJ	Krakow
Poland	Oddzial Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ	Nowy Sacz
Poland	Szpital Wojewódzki w Przemyslu	Przemysl
Poland	Instytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala Wyszynskiego	Warszawa
Poland	Slaskie Centrum Chorob Serca	Zabrze

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Countries where clinical trial is conducted

Hungary,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ST resolution >70% 60 minutes after PCI
Secondary	Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale = 1
Secondary	TIMI 3 flow after PCI
Secondary	MBG 3
Secondary	CMR – infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF)
Secondary	ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI)
Secondary	Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up
Secondary	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