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

NCT ID: NCT01456364

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Heart Disease

Keywords

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clopidogrel low response ticagrelor prasugrel platelet aggregation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ticagrelor

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

Group Type ACTIVE_COMPARATOR

Ticagrelor

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Prasugrel

Intervention Type 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

Interventions

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Ticagrelor

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katharina Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum München

Martin Orban, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Ludwig-Maximilian-Universität München, Campus Großhadern

Daniel Aradi, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Balatonfüred, Dept. of Cardiology

Locations

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Deutsches Herzzentrum

München, Bavaria, Germany

Site Status RECRUITING

Klinikum der Ludwig-Maximilians-Universität München

München, Bavaria, Germany

Site Status RECRUITING

Heart Center Balatonfüred, Dept. of Cardiology

Balatonfüred, , Hungary

Site Status NOT_YET_RECRUITING

Countries

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Germany Hungary

Central Contacts

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Katharina Mayer, MD

Role: CONTACT

Phone: +49-89-1218-2020

Email: [email protected]

Isabell Bernlochner, MD

Role: CONTACT

Phone: +49-89-1218-0

Email: [email protected]

Facility Contacts

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Katharina Mayer, MD

Role: primary

Isabell Bernlochner, MD

Role: backup

Martin Orban, MD

Role: primary

Dirk Sibbing, MD

Role: backup

Daniel Aradi, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19264241 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17982182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19717846 (View on PubMed)

Other Identifiers

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GE-DHM A01811

Identifier Type: -

Identifier Source: org_study_id