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

Sponsor

Deutsches Herzzentrum Muenchen (Other)

Overall Status

Unknown status

CT.gov ID

NCT01456364

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

23.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	Drug: Ticagrelor Drug: Prasugrel	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Apr 1, 2014

Anticipated Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ticagrelor A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily	Drug: Ticagrelor A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily
Active Comparator: 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	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

Arm

Intervention/Treatment

Active Comparator: Ticagrelor

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

Drug: Ticagrelor

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

Active Comparator: 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

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

Outcome Measures

Primary Outcome Measures

ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel [Day 2 post randomization]

Secondary Outcome Measures

Proportion of low responders in ticagrelor or prasugrel group [Day 2 post randomization]
Low platelet response is defined as platelet aggregation values >=468 AU*min
Proportion of enhanced responders in ticagrelor or prasugrel group [Day 2 post randomization]
Enhanced platelet response is defined as platelet aggregation values <= 188 AU*min

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

Principal Investigator: 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