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ISAR-REACT 5


Prospective, randomized trial of ticagrelor versus prasugrel in patients with acute coronary syndrome (ISAR-REACT 5)

Cardiovascular diseases caused by a blockage or severe narrowing of the coronary artery fall into the category of acute coronary syndrome (ACS). ACS and the life-threatening disturbances of heart perfusion associated with it range from instable angina pectoris to myocardial infarction. Despite the fact that huge progress has been made in the treatment of ACS with the use of drugs that prevent blood clotting and targeted therapy, ACS-related morbidity and mortality remain high. In Germany, an estimated 350,000 new cases of ACS are diagnosed each year.

This study compares two agents used to inhibit blood clotting - ticagrelor and prasugrel. It is designed to make a significant contribution to antithrombotic therapy in ACS patients so that clinical outcomes can be improved.

The hypothesis that ticagrelor is superior to prasugrel for the treatment of patients with acute coronary syndrome will be examined in relation to clinical outcomes. This is based on:

  • the possibility of pre-treatment independent of clinical presentation and coronary anatomy
  • consistently positive results in the sub-group of patients with conservative treatment strategy
  • potentially positive effects of ticagrelor as a result of its interaction with adenosine metabolism, which affects several genes

To test this hypothesis 4,000 ACS patients are to receive either ticagrelor or prasugrel over a 12-month period and a comparative analysis of the two active agents will be performed.

Principal Investigators
Principal investigator: Adnan Kastrati (München), Co-PI: Stefanie Schüpke (München)

Medical institution
Deutsches Herzzentrum München

Keywords
ticagrelor, prasugrel, acute coronary syndrome, percutaneous coronary intervention

Recruitment start
09/2013

Patients (planned)
4000

Patients (recruited)
4018 (completed)

ClinicalTrials.gov

Category
Guideline relevant study

Status
DZHK-teilfinanzierte Studie

Operative contact: Marion Janisch, MD
janischm@dhm.mhn.de