Trial document




drksid header

  DRKS00009739

Trial Description

start of 1:1-Block title

Title

Pharmacodynamic comparison of different oral P2Y12-receptor inhibitor loading strategies for transitioning from cangrelor in patients undergoing coronary stenting

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ExcelsiorLOAD2

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Patients undergoing coronary stent implantation due to coronary stenosis require a sufficient inhibition of platelet function for prevention of coronary re-occlusions.
Cangrelor is the first inhibitor of platelet function via inhibition of the ADP-receptor that can be given intravenously. Its advantage is a faster onset and offset of platelet inhibition compared to orally given durgs.
As patients require a continuous platelet inhibition also after the coronary intervention, the intravenous therapy with cangrelor have to be transitioned to orally given platelet inhibitors. However, the ideal point of time for the first oral loading dose is not well defined. This study aims to compare loading with Ticagrelor 180mg or Prasugrel 60mg given at start of cangrelor-infusion and before coronary intervention versus loading with Clopidogrel 600mg given directly after discontinuation of cangrelor.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Cangrelor ist the first intravenous P2Y12-Inhibitor, which provides a significant faster onset of platelet inhibition during PCI as compared to loading with orally given P2Y12-inhibitors.
It has been shown that Clopidogrel can only be initiated only after discontinuation of cangrelor infusion due to an interactions between active metabolites of both agents. However, this results in a short period with reduced platelet inhibition after PCI with possible negative effects for the patient.
The aim of this study is to investigate different regimens with loading with Prasugrel 60mg or Ticagrelor 180mg already at the beginning of cangrelor infusion before PCI in order to achieve sufficient platelet inhibition also directly after PCI, as compared to loading with Clopidogrel 600mg after discontinuation of the cangrelor infusion.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009739
  •   2016/01/26
  •   [---]*
  •   yes
  •   Approved
  •   549/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2015-005071-25 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I25 -  Chronic ischaemic heart disease
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Kengrexal (Cangrelor), intravenous bolus of 30µg/kg followed by an infusion of 4µg/kg/min over at least 2 hours or till the end of PCI.

    Efient (Prasugrel), 60mg Loading dose p.o. (tablet), single dose at the beginning of PCI.
  •   Kengrexal (Cangrelor), intravenous bolus of 30µg/kg followed by an infusion of 4µg/kg/min over at least 2 hours or till the end of PCI.

    Brilique (Ticagrelor), 180mg Loading dose p.o. (tablet), single dose at the beginning of PCI.
  •   Kengrexal (Cangrelor), intravenous bolus of 30µg/kg followed by an infusion of 4µg/kg/min over at least 2 hours or till the end of PCI.

    Plavix (Clopidogrel), 600mg loading dose p.o. (tablet), single dose after discontinuation of Kengrexal-infusion.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IIIb
  •   Yes
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Proportion of patients with ADP-induced platelet aggregation < 468 AU x min (Multiplate-Test, Roche Diagnostics) tested 1 hour after discontinuation of cangrelor.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Proportion of patients with ADP-induced platelet aggregation beween 189 and 467 AU x min (Multiplate-Test, Roche Diagnostics)
- Analysis of platelet reactivity as continous variable at different time points
- Interaction of genetic polymorphisms (e.g. CYP2C19), clinical and laboratory variables with pharmacodynamic effects in the different treatment arms
- Ischemic endpoints, bleeding events

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/01/26
  •   110
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Hemodynamically stable patients with obstructive coronary heart disease and planned coronary stent implantation
- Pretreatment with aspirin
- Men and women over the age of 18 years
- Written informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Acute myocardial infarction
- Treatment with P2Y12-receptor inhibitor, fibrinolysis or GPIIb/IIIa inhibitor within 7 days before enrollment
- Contraindication for treatment with aspirin, cangrelor, clopidogrel, ticagrelor or prasugrel according to EMEA label (in particular: Allergy, Active bleeding or high bleeding risk, history of stroke or TIA, severe liver disease)
- Severe thrombocytopenia (<50.000/µl)
- Known severe disorder of the coagulation system
- Pregnancy or lactation

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
    • Mr.  Prof. Dr. med. Dr. h.c. mult.  Jörg Rüdiger  Siewert 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitäts-Herzzentrum Freiburg Bad KrozingenKlinik für Kardiologie und Angiologie II
    • Mr.  PD Dr. med.  Willibald  Hochholzer 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitäts-Herzzentrum Freiburg Bad KrozingenKlinik für Kardiologie und Angiologie II
    • Mr.  PD Dr. med.  Willibald  Hochholzer 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitäts-Herzzentrum Freiburg Bad KrozingenKlinik für Kardiologie und Angiologie II
    • Mr.  PD Dr.  Willibald   Hochholzer 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   +49-7633-402-4285
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/06/07
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.