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Myocardial InfarctionPhase 4NCT00377650

Polish-Italian-Hungarian RAndomized ThrombEctomy Trial

A Phase 4 study testing Percutaneous thrombectomy in people with Myocardial Infarction, run by Jagiellonian University at 9 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Aim Primary percutaneous coronary intervention efficacy improvement by DIVER CE thrombectomy system leading to thrombus reduction. Study design: Multicenter, prospective, opened, randomized. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
Percutaneous thrombectomy
Type of treatment
Medical device
How many people
200 participants
Where
9 sitesin 3 countries
Study dates
Sep 2005to Dec 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 35Show fewer
  • 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

Trial locations and contacts

9 sites in 3 countries.

Dariusz Dudek, MD contact

124247181 ext. +48

mcdudek@cyf-kr.edu.pl

9 sites in 3 countries

Poland6 sites, 6 recruiting

  • Górnośląskie Centrum Medyczne

    Katowice

    Andrzej Ochala, Md, aochala@poczta.onet.pl

    Andrzej Ochała, MD

    Recruiting

  • Zaklad Hemodynamiki i Angiokardiohrafii IK CMUJ

    Krakow, 31-501

    Waldemar A Mielecki, MD, 124247181 ext. +48, wmielecki@su.krakow.pl

    Dariusz Dudek, MD

    Recruiting

  • Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ

    Nowy Sącz

    Renata Korpak-Wysocka, MD, 184407487 ext. +48

    Renata Korpak-Wysocka, MD

    Recruiting

  • Szpital Wojewódzki w Przemyślu

    Przemyśl

    Andrzej Wiśniewski, MD, 166775000 ext. +48

    Andrzej Wiśniewski, MD

    Recruiting

  • Instytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala Wyszynskiego

    Warsaw, 04-628

    Adam Witkowski, MD, witkowski@hbz.pl

    Adam Witkowski, MD

    Recruiting

  • Slaskie Centrum Chorob Serca

    Zabrze

    Mariusz Gasior, MD, m.gasior@sccs.pl

    Mariusz Gasior, MD

    Recruiting

Other trials in Poland

Italy2 sites, 2 recruiting

  • Cardiology Department Hospital Villascassi

    Genova

    Paolo Rubartelli, MD, paolo.rubartelli@villascassi.it

    Paolo Rubartelli, MD

    Recruiting

  • Institute of Cardiology, Catholic University

    Rome

    Francesco Burzotta, MD, f.burzotta@rm.unicatt.it

    Francesco Burzotta, MD

    Recruiting

Other trials in Italy

Hungary1 site, 1 recruiting

  • Institute, Medical School of University Pecs

    Pécs

    Ivan Horvath, MD, ivan.g.horvath@aok.pte.hu

    Ivan Horvath, MD

    Recruiting

Other trials in Hungary

About this study

Official title: Polish-Italian-Hungarian RAndomized ThrombEctomy Trial. PIHRATE Trial.

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

Study design:

Read more

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

Being tested
Percutaneous thrombectomy
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous thrombectomyDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ST resolution >70% 60 minutes after PCI

Secondary outcomes (7)

  1. Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1

  2. TIMI 3 flow after PCI

  3. MBG 3

  4. CMR - infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF)

  5. ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI)

  6. Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up

  7. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2006 (estimated)
  2. Study startSep 2005
  3. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00377650
Sponsor's protocol ID
JagiellonianU
Status last verified
Jan 2007
First submitted
14 Sep 2006
Last updated
17 Jan 2007
Results posted
No

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.

    PubMed 21095287

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Percutaneous thrombectomy in people with Myocardial Infarction, run by Jagiellonian University at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Poland, Italy, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dariusz Dudek, MD (124247181 ext. +48, mcdudek@cyf-kr.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ST resolution >70% 60 minutes after PCI. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00377650, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2007.

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