Back to resultsIntracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing (ISAR ADAPT PF)
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ticagrelor
Prasugrel
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring clopidogrel low response, ticagrelor, prasugrel, platelet aggregation
Eligibility 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
Sites / Locations
- Deutsches HerzzentrumRecruiting
- Klinikum der Ludwig-Maximilians-Universität MünchenRecruiting
- Heart Center Balatonfüred, Dept. of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ticagrelor
Prasugrel
Arm Description
A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily
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
Outcomes
Primary Outcome Measures
ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel
Secondary Outcome Measures
Proportion of low responders in ticagrelor or prasugrel group
Low platelet response is defined as platelet aggregation values >=468 AU*min
Proportion of enhanced responders in ticagrelor or prasugrel group
Enhanced platelet response is defined as platelet aggregation values <= 188 AU*min
Full Information
NCT ID
NCT01456364
First Posted
October 18, 2011
Last Updated
October 31, 2013
Sponsor
Deutsches Herzzentrum Muenchen
1. Study Identification
Unique Protocol Identification Number
NCT01456364
Brief Title
Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing
Acronym
ISAR ADAPT PF
Official Title
Prospective, Randomized Study of the Platelet Inhibitory Efficacy of Ticagrelor Versus Prasugrel in Clopidogrel Low Responders After Percutaneous Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
clopidogrel low response, ticagrelor, prasugrel, platelet aggregation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor
Arm Type
Active Comparator
Arm Description
A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily
Arm Title
Prasugrel
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
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
Primary Outcome Measure Information:
Title
ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel
Time Frame
Day 2 post randomization
Secondary Outcome Measure Information:
Title
Proportion of low responders in ticagrelor or prasugrel group
Description
Low platelet response is defined as platelet aggregation values >=468 AU*min
Time Frame
Day 2 post randomization
Title
Proportion of enhanced responders in ticagrelor or prasugrel group
Description
Enhanced platelet response is defined as platelet aggregation values <= 188 AU*min
Time Frame
Day 2 post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina Mayer, MD
Phone
+49-89-1218-2020
Email
mayer.katharina@dhm.mhn.de
First Name & Middle Initial & Last Name or Official Title & Degree
Isabell Bernlochner, MD
Phone
+49-89-1218-0
Email
isabell.bernlochner@gmx.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharina Mayer, MD
Organizational Affiliation
Deutsches Herzzentrum München
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Orban, MD
Organizational Affiliation
Klinikum der Ludwig-Maximilian-Universität München, Campus Großhadern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Aradi, MD
Organizational Affiliation
Heart Center Balatonfüred, Dept. of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum
City
München
State/Province
Bavaria
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharina Mayer, MD
Phone
+49-89-1218-2020
Email
mayer.katharina@dhm.mhn.de
First Name & Middle Initial & Last Name & Degree
Isabell Bernlochner, MD
Phone
+49-89-4140-0
Email
isabell.bernlochner@gmx.de
First Name & Middle Initial & Last Name & Degree
Katharina Mayer, MD
First Name & Middle Initial & Last Name & Degree
Isabell Bernlochner, MD
Facility Name
Klinikum der Ludwig-Maximilians-Universität München
City
München
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Orban, MD
Phone
+49 89 7095 2371
Email
martin.Orban@med.uni-muenchen.de
First Name & Middle Initial & Last Name & Degree
Dirk Sibbing, MD
Phone
+49 89 5160 2215
Email
Dirk.Sibbing@med.uni-muenchen.de
First Name & Middle Initial & Last Name & Degree
Martin Orban, MD
First Name & Middle Initial & Last Name & Degree
Dirk Sibbing, MD
Facility Name
Heart Center Balatonfüred, Dept. of Cardiology
City
Balatonfüred
ZIP/Postal Code
8230
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Aradi, MD
Phone
+36302355639
Email
daniel_aradi@yahoo.com
First Name & Middle Initial & Last Name & Degree
Daniel Aradi, MD
First Name & Middle Initial & Last Name & Degree
Jozsef Faluközy, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19264241
Citation
Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schomig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030.
Results Reference
background
PubMed Identifier
17982182
Citation
Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.
Results Reference
background
PubMed Identifier
19717846
Citation
Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
Results Reference
background
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Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing
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