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
  Purpose

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.


Condition Intervention Phase
Coronary Heart Disease
Drug: Ticagrelor
Drug: Prasugrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized Study of the Platelet Inhibitory Efficacy of Ticagrelor Versus Prasugrel in Clopidogrel Low Responders After Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel [ Time Frame: Day 2 post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 70
Study Start Date: September 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ticagrelor
A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily
Drug: Ticagrelor
A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456364

Contacts
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

Locations
Germany
Deutsches Herzzentrum Recruiting
München, Bavaria, Germany, 80636
Contact: Katharina Mayer, MD    +49-89-1218-2020    mayer.katharina@dhm.mhn.de   
Contact: Isabell Bernlochner, MD    +49-89-4140-0    isabell.bernlochner@gmx.de   
Principal Investigator: Katharina Mayer, MD         
Sub-Investigator: Isabell Bernlochner, MD         
Klinikum der Ludwig-Maximilians-Universität München Recruiting
München, Bavaria, Germany, 81377
Contact: Martin Orban, MD    +49 89 7095 2371    martin.Orban@med.uni-muenchen.de   
Contact: Dirk Sibbing, MD    +49 89 5160 2215    Dirk.Sibbing@med.uni-muenchen.de   
Principal Investigator: Martin Orban, MD         
Sub-Investigator: Dirk Sibbing, MD         
Hungary
Heart Center Balatonfüred, Dept. of Cardiology Not yet recruiting
Balatonfüred, Hungary, 8230
Contact: Daniel Aradi, MD    +36302355639    daniel_aradi@yahoo.com   
Principal Investigator: Daniel Aradi, MD         
Sub-Investigator: Jozsef Faluközy, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
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
  More Information

Publications:
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01456364     History of Changes
Other Study ID Numbers: GE-DHM A01811
Study First Received: October 18, 2011
Last Updated: October 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:
clopidogrel low response
ticagrelor
prasugrel
platelet aggregation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Prasugrel
Ticagrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014