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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01456364
First Posted: October 20, 2011
Last Update Posted: November 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
October 18, 2011
October 20, 2011
November 1, 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 ]
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 ]
    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 ]
    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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Hungary
 
 
NCT01456364
GE-DHM A01811
Yes
Not Provided
Not Provided
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