Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing (ISAR ADAPT PF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01456364
First received: October 18, 2011
Last updated: October 31, 2013
Last verified: October 2013

October 18, 2011
October 31, 2013
September 2011
April 2014   (final data collection date for primary outcome measure)
ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel [ Time Frame: Day 2 post randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01456364 on ClinicalTrials.gov Archive Site
  • Proportion of low responders in ticagrelor or prasugrel group [ Time Frame: Day 2 post randomization ] [ Designated as safety issue: No ]
    Low platelet response is defined as platelet aggregation values >=468 AU*min
  • Proportion of enhanced responders in ticagrelor or prasugrel group [ Time Frame: Day 2 post randomization ] [ Designated as safety issue: No ]
    Enhanced platelet response is defined as platelet aggregation values <= 188 AU*min
Same as current
Not Provided
Not Provided
 
Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing
Prospective, Randomized Study of the Platelet Inhibitory Efficacy of Ticagrelor Versus Prasugrel in Clopidogrel Low Responders After Percutaneous Coronary Intervention

Clopidogrel low response is associated with a significantly higher risk for ischemic complications after percutaneous coronary intervention. Ticagrelor and prasugrel are more potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic events as compared to clopidogrel. No direct comparison between ticagrelor and prasugrel in terms of their antiplatelet efficacy exists. The aim of this study is to assess the antiplatelet treatment efficacy of ticagrelor versus prasugrel over time in confirmed clopidogrel low responders undergoing percutaneous coronary intervention.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Heart Disease
  • Drug: Ticagrelor
    A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily
  • Drug: Prasugrel
    A prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients < 75 years or a 5 mg maintenance dose per day for patients >= 75 years
  • Active Comparator: Ticagrelor
    A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily
    Intervention: Drug: Ticagrelor
  • Active Comparator: Prasugrel
    A prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients < 75 years or a 5 mg maintenance dose per day for patients >= 75 years
    Intervention: Drug: Prasugrel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
May 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • successful PCI
  • 600 mg clopidogrel pretreatment
  • clopidogrel low response assessed with electrode aggregometry (>= 486 AU*min)
  • written informed consent

Exclusion Criteria:

  • Contraindications or allergies against study drugs
  • Anemia
  • Any surgery < 6 weeks
  • Increased bleeding risk
  • Oral anticoagulation
  • platelet count < 100.000/µl
  • Prior history of stroke or pathologic intracranial findings
  • GPIIb/IIIa antagonists < 10 days or periprocedural
  • Age > 80 years, < 18 years
  • Body weight < 60 kg
  • Cardiogenic shock
  • Increased risk of bradycardia
  • Moderate liver disease
  • Kidney dialysis
  • Intake of CYP 3A4 inhibitors
  • Pregnancy or lactation
  • Missing pregnancy test for women capable of bearing children
Both
18 Years to 80 Years
No
Contact: Katharina Mayer, MD +49-89-1218-2020 mayer.katharina@dhm.mhn.de
Contact: Isabell Bernlochner, MD +49-89-1218-0 isabell.bernlochner@gmx.de
Germany,   Hungary
 
NCT01456364
GE-DHM A01811
Yes
Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
Not Provided
Principal Investigator: Katharina Mayer, MD Deutsches Herzzentrum München
Principal Investigator: Martin Orban, MD Klinikum der Ludwig-Maximilian-Universität München, Campus Großhadern
Principal Investigator: Daniel Aradi, MD Heart Center Balatonfüred, Dept. of Cardiology
Deutsches Herzzentrum Muenchen
October 2013

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