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

NCT01456364 | Unknown Phase 4 DMC

• 1 other identifier: GE-DHM A01811
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 3

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.

Conditions

Coronary Heart Disease

Keywords

clopidogrel low response; ticagrelor; prasugrel; platelet aggregation

Outcome Measures

Primary Outcomes (1)

• ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel

  Day 2 post randomization

Secondary Outcomes (2)

• Proportion of low responders in ticagrelor or prasugrel group

  Day 2 post randomization

• Proportion of enhanced responders in ticagrelor or prasugrel group

  Day 2 post randomization

Study Arms (2)

Ticagrelor

ACTIVE COMPARATOR

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

Drug: Ticagrelor

Prasugrel

ACTIVE COMPARATOR

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

Interventions

Ticagrelor DRUG

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

Ticagrelor

Prasugrel DRUG

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

Prasugrel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• successful PCI
• mg clopidogrel pretreatment
• clopidogrel low response assessed with electrode aggregometry (\>= 486 AU\*min)
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (3)

Deutsches Herzzentrum

München, Bavaria, 80636, Germany

RECRUITING

Klinikum der Ludwig-Maximilians-Universität München

München, Bavaria, 81377, Germany

RECRUITING

Heart Center Balatonfüred, Dept. of Cardiology

Balatonfüred, 8230, Hungary

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 19264241 BACKGROUND

• 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.

  PMID: 17982182 BACKGROUND

• 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.

  PMID: 19717846 BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Interventions

Ticagrelor; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharina Mayer, MD

CONTACT

+49-89-1218-2020; mayer.katharina@dhm.mhn.de

Isabell Bernlochner, MD

CONTACT

+49-89-1218-0; isabell.bernlochner@gmx.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: October 20, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

DE (2); HU (1)