Clinical trial NCT01456364: Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Keywords: clopidogrel low response
ticagrelor
prasugrel
platelet aggregation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2011-10-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel
timeFrame: Day 2 post randomization
Secondary outcomes:
measure: Proportion of low responders in ticagrelor or prasugrel group
timeFrame: Day 2 post randomization
measure: Proportion of enhanced responders in ticagrelor or prasugrel group
timeFrame: Day 2 post randomization
Other outcomes:
Locations:
city: München
country: Germany
facility: Deutsches Herzzentrum
state: Bavaria
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universität München
state: Bavaria
city: Balatonfüred
country: Hungary
facility: Heart Center Balatonfüred, Dept. of Cardiology
Study officials:
affiliation: Deutsches Herzzentrum München
name: Katharina Mayer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum der Ludwig-Maximilian-Universität München, Campus Großhadern
name: Martin Orban, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center Balatonfüred, Dept. of Cardiology
name: Daniel Aradi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.