drugset / Trial / NCT01968200

Prevention of Anthracycline-induced Cardiotoxicity

NCT01968200

Phase 3 Unknown 268 enrolled European Institute of Oncology
RandomizedParallel-groupOpen-labelTreatment

Summary

Anthracycline based anti-tumoral therapies are know to develop cardiac damage that could also lead to heart failure. Monocentric studies proved that a treatment with ACE inhibitors (ACEi) and betablockers (BB) during the first elevation of cardiac troponin is able to reduce the incidence of heart failure (HF). ICOS-ONE trial is a multicenter randomized trial comparing two therapeutic strategies. The main objective is to assess whether enalapril started concomitantly to AC-containing treatments, can prevent cardiac toxicity more effectively than when enalapril is prescribed to selected patients showing laboratory evidences of injury after chemotherapy, during follow-up visits in 268 patients.

Timeline

Start
2012-12
Primary completion
2019-12
Completion
2023-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Enalapril Other / unclassified 2.5 mg
Subject Enalapril Other / unclassified 10 mg

Indications