Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing

Coronary Heart Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01456364
• Other study ID #: GE-DHM A01811
• Status: Recruiting
• Phase: Phase 4
• First received: October 18, 2011
• Last updated: October 31, 2013
• Start date: September 2011
• Est. completion date: May 2014

Study information

• Verified date: October 2013
• Source: Deutsches Herzzentrum Muenchen
• Contact: Katharina Mayer, MD
• Phone: +49-89-1218-2020
• Email: mayer.katharina[@]dhm.mhn.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Ticagrelor
A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily
• 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

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum	München	Bavaria
Germany	Klinikum der Ludwig-Maximilians-Universität München	München	Bavaria
Hungary	Heart Center Balatonfüred, Dept. of Cardiology	Balatonfüred

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Countries where clinical trial is conducted

Germany,  Hungary, 

References & Publications (3)

Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schömig 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. — View 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, Thorsén 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. — View 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. Epub 2007 Nov 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel		Day 2 post randomization	No
Secondary	Proportion of low responders in ticagrelor or prasugrel group	Low platelet response is defined as platelet aggregation values >=468 AU*min	Day 2 post randomization	No
Secondary	Proportion of enhanced responders in ticagrelor or prasugrel group	Enhanced platelet response is defined as platelet aggregation values <= 188 AU*min	Day 2 post randomization	No