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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01456364

Acronym

ISAR ADAPT PF

Enrollment

Registered

2011-10-20

Start date

2011-09-30

Completion date

2014-05-31

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

clopidogrel low response, ticagrelor, prasugrel, platelet aggregation

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.

Interventions

DRUGTicagrelor

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

DRUGPrasugrel

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel	Day 2 post randomization

Secondary

Measure	Time frame	Description
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

Countries

Germany, Hungary

Contacts

Primary ContactKatharina Mayer, MD

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

Backup ContactIsabell Bernlochner, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026