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Atorvastatin for Prevention of Anthracycline-Induced Cardiotoxicity
NCT05792293Phase 3
Key facts
- Status
- Unknown
- Start
- Jun 2021
- Primary completion
- Jun 2023
- Countries
- 1
- Sponsor
- Ain Shams University
- Modality
- Small Molecules
- Drugs
- atorvastatin
- Conditions
- anthracycline-induced cardiotoxicity
01
Overview
Phase 3, randomised, single-blind trial of atorvastatin in anthracycline-induced cardiotoxicity (2 arms), sponsored by Ain Shams University. Primary endpoint: Incidence of cancer therapy related cardiac dysfunction at 6 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Study Group
Atorvastatin 40 mg + Anthracycline chemotherapy
Control Group
Placebo + Anthracycline chemotherapy
03
Who it enrols
Female patients with histology proven breast cancer indicated for anthracycline-based therapy, excluding those with impaired LV function, severe valvular disease, CAD, or prior chemo/radiation.
04
Endpoints
Primary
Incidence of cancer therapy related cardiac dysfunction
Secondary
Changes in left ventricular ejection fraction
Changes in left ventricular volumes
Changes in left ventricular diastolic function
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