Status:

UNKNOWN

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

Lead Sponsor:

Deutsches Herzzentrum Muenchen

Conditions:

Coronary Heart Disease

Eligibility:

All Genders

18-80 years

Phase:

PHASE4

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 inhibitor...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2014

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT01456364

Start Date

September 1 2011

End Date

May 1 2014

Last Update

November 1 2013

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Deutsches Herzzentrum

München, Bavaria, Germany, 80636

2

Klinikum der Ludwig-Maximilians-Universität München

München, Bavaria, Germany, 81377

3

Heart Center Balatonfüred, Dept. of Cardiology

Balatonfüred, Hungary, 8230