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

Condition(s) targeted: Coronary Heart Disease

Intervention: Ticagrelor (Drug); Prasugrel (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Deutsches Herzzentrum Muenchen

Official(s) and/or principal investigator(s):
Dirk Sibbing, MD, Principal Investigator, Affiliation: Deutsches Herzzentrum München

Overall contact:
Dirk Sibbing, MD, Phone: +49-89-1218-4578, Email: dirk@sibbing.net

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.

Official title: Prospective, Randomized Study of the Platelet Inhibitory Efficacy of Ticagrelor Versus Prasugrel in Clopidogrel Low Responders After Percutaneous Coronary Intervention

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

Primary outcome: ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel

Secondary outcome:

Proportion of low responders in ticagrelor or prasugrel group

Proportion of enhanced responders in ticagrelor or prasugrel group

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- successful PCI

- 600 mg clopidogrel pretreatment

- clopidogrel low response assessed with multiple 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

Dirk Sibbing, MD, Phone: +49-89-1218-4578, Email: dirk@sibbing.net

Klinikum Rechts der Isar, Munich, Bavaria 81675, Germany; Recruiting
Isabell Bernlochner, MD
Isabell Bernlochner, MD, Sub-Investigator

Deutsches Herzzentrum, München, Bavaria 80636, Germany; Recruiting
Dirk Sibbing, MD, Phone: +49-89-1218-4578, Email: dirk@sibbing.net
Isabell Bernlochner, MD, Sub-Investigator
Katharina Mayer, MD, Sub-Investigator

Related publications:

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.

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.

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. Epub 2009 Aug 30.

Starting date: September 2011
Last updated: October 18, 2011