Trial document




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  DRKS00000603

Trial Description

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Title

prospective, doubleblind, randomized, placebocontrolled Trial with Abciximab to reduce coronary microembolism during PCI in patient with stable angina pectoris

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Trial Acronym

REOPRO HITS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to investigate if ReoPro (gerneric name Abciximab)compared to placebo (an medication with the sam view but without effect) is able to reduce little vessel occlusions (microembolism) in coronary arteries occuring during a planned heart intervention (PCI) in 60 Patients with stable angina pectoris (heart pain).

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Brief Summary in Scientific Language

After percutaneous coronary interventions (PCI), a reduced coronary flow velocity reserve (CFVR) is frequently observed, often associated with an elevation of cardiac marker enzymes. Coronary microembolism may account for these observations. As demonstrated in the cerebral circulation, high-intensity transient signals (HITS) in the Doppler velocity spectrum correspond to microemboli. We have shown that the detection of HITS during PCI with an intracoronary Doppler ultrasound device is feasible also in the coronary circulation. Coronary microembolism is frequently induced during PCI, especially after stent implantation. Patients with pNSTEMI had a significantly higher frequency of coronary microembolization during PCI, and their systemic inflammatory response and microvascular impairment after PCI were more pronounced. Intracoronary Doppler ultrasound provides evidence that pNSTEMI in patients undergoing elective PCI is caused by microembolization during the procedure. The goal of the study is to investigate if Abciximab compared to placebo is able to reduce coronary microembolism occuring during elektive PCI in 60 Patients with stable angina pectoris.

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Organizational Data

  •   DRKS00000603
  •   2010/11/23
  •   [---]*
  •   yes
  •   Approved
  •   2906-08/10, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  •   2010-019688-12 
  •   1176/01 
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Health Condition or Problem studied

  •   I25.9 -  Chronic ischaemic heart disease, unspecified
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Interventions/Observational Groups

  •   agent: Abciximab
    tradename: Reopro
    application: i.v. of bolus and maintenance dose
    dose: initial 0,25 mg/kg body weight 10 min before planned intervention, and then 0,125 µg/kg body weight/min up to 12 h after intervention (but not more than 10 µg/min)
  •   Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   [---]*
  •   Placebo
  •   Prognosis
  •   Parallel
  •   IV
  •   [---]*
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Primary Outcome

Count of measured Microembolism (HITS) which will be detected using an ultrasound guidewire during intervention

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Secondary Outcome

changes in CK, CK-MB, hs-CRP, cTNI, Thrombocytes decrease and bleedings as biomarker of myocardial damage or as side effect of abciximab

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2010/12/12
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

-age 18 until 80 years
-indication of a coronary angiography
-stable angina pectoris or detection of a ischemic event
-written patient information and consent (PIC)

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Exclusion Criteria

increase of cardiac markers before PCI, thus excluding STEMI/NSTEMI
left bundle branch block
terminal renal insufficiency
hypothyroidism
skeletal muscle injury
occluded target artery, bifurcation lesion, or instent restenosis, multivessel intervention, sidebranch occlusion, or prolonged vasospasm, contraindication for antiplatelet medications

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Addresses

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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    • Universitätsklinikum Jena, Klinik für Innere Medizin 1, Kardilogie
    • Mr.  PD Dr. disc. pol. Dr. med.  Markus  Ferrari 
    • Erlanger-Allee 101
    • 07747  Jena
    • Germany
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    • Universitätsklinikum Jena, Klinik für Innere Medizin 1, Kardiologie
    • Mr.  Dr. med.  Daniel  Kretzschmar 
    • Erlanger-Allee 101
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.