Trial document




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  DRKS00004274

Trial Description

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Title

Non-interventional study to determine platelet reactivity in patients with STEMI / NSTE-ACS and percutaneous coronary revascularization on treatment with P2Y12 receptor antagonists

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Trial Acronym

Kein Akronym

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients with acute coronary complaints undergoing dilatation of coronary artery vessels and implantation of stents at the narrowed lesions are treated with drugs inhibiting the clotting of platelets and thereby the occlusion of the blood vessels with subsequent myocardial infarction. The drugs prasugrel or ticagrelor are prescribed in addition to aspirin. Because it is unknown so far, we aim to evaluate the antiplatelet activity of these drugs at the time of coronary catheterization and at day after intervention.

Efficacy will be compared with the ones observed in healthy subjects respective in patients without acute myocardial infarction.

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Brief Summary in Scientific Language

This registry will evaluate the time course and the extent of platelet inhibition in patients with STEMI or NSTE-ACS treated with prasugrel or ticagrelor. The study hypothesis is that the onset of antiplatelet effect of prasugrel or ticagrelor is delayed in patients with STEMI or NSTE-ACS if compared with the time course of effect in healthy volunteers or patients with stable coronary artery disease.

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Organizational Data

  •   DRKS00004274
  •   2012/07/25
  •   [---]*
  •   yes
  •   Approved
  •   273/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I20.0 -  Unstable angina
  •   I21.0 -  Acute transmural myocardial infarction of anterior wall
  •   I21.1 -  Acute transmural myocardial infarction of inferior wall
  •   I21.2 -  Acute transmural myocardial infarction of other sites
  •   I21.3 -  Acute transmural myocardial infarction of unspecified site
  •   I21.4 -  Acute subendocardial myocardial infarction
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Interventions/Observational Groups

  •   Non-interventional study in patients treated with a loading dose of prasugrel 60 mg as regular care
  •   Non-interventional study in patients treated with a loading dose of ticagrelor 180 mg as regular care
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Other
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Platelet reactivity (PRU) at PCI determined by VerifyNow P2Y12 assay

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Secondary Outcome

Platelet reactivity at PCI and at day 1 after PCI determined by light transmission aggregometry Platelet reactivity at PCI and at day 1 after PCI determined by impedance aggregometry (MEIA test) Platelet reactivity at day 1 after PCI determined by VerifyNow P2Y12 assay

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2012/08/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Are at least 18 years of age - Subjects with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS) admitted at Universitäts-Herzzentrum Freiburg-Bad Krozingen at Bad Krozingen - Indication for urgent percutaneous coronary revascularization

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Exclusion Criteria

- Medical or mental condition preventing to provide written informed consent - Acute clinical relevant bleeding - Treatment with a GP IIb/IIIa inhibitor wihin one week prior or during PCI

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Addresses

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    • Universitäts-Herzzentrum Freiburg - Bad Krozingen, Klinik für Kardiologie und Angiologie II
    • Mr.  Prof. Dr. med.  Franz-Josef   Neumann 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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    • Universitäts-Herzzentrum Freiburg - Bad Krozingen, Klinik für Kardiologie und Angiologie II
    • Mr.  Prof. Dr. med.  Franz-Josef  Neumann 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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    • Universitäts-Herzzentrum Freiburg - Bad Krozingen, Klinik für Kardiologie und Angiologie II, Abt. Klinische Pharmakologie
    • Mr.  Prof. Dr.rer. nat.  Dietmar  Trenk 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitäts-Herzzentrum Freiburg - Bad Krozingen, Klinik für Kardiologie und Angiologie II
    • Mr.  Prof. Dr. med.  Franz-Josef  Neumann 
    • Südring 15
    • 79189  Bad Krozingen
    • 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.