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Polish-Italian-Hungarian RAndomized ThrombEctomy Trial

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ClinicalTrials.gov Identifier: NCT00377650
Recruitment Status : Unknown
Verified January 2007 by Jagiellonian University.
Recruitment status was:  Recruiting
First Posted : September 18, 2006
Last Update Posted : January 17, 2007
Sponsor:
Information provided by:
Jagiellonian University

Tracking Information
First Submitted Date  ICMJE September 14, 2006
First Posted Date  ICMJE September 18, 2006
Last Update Posted Date January 17, 2007
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2006)
ST resolution >70% 60 minutes after PCI
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Polish-Italian-Hungarian RAndomized ThrombEctomy Trial
Official Title  ICMJE Polish-Italian-Hungarian RAndomized ThrombEctomy Trial. PIHRATE Trial.
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE Device: Percutaneous thrombectomy
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 14, 2006)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Italy,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00377650
Other Study ID Numbers  ICMJE JagiellonianU
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Jagiellonian University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dariusz Dudek, MD Jagiellonian University
PRS Account Jagiellonian University
Verification Date January 2007

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