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Clinical trial

Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

ID
Name
FMASUMD45/2021
Description
This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity
Trial arms
Trial start
2021-06-01
Estimated PCD
2023-06-01
Trial end
2023-06-01
Status
Recruiting
Phase
Early phase I
Treatment
Atorvastatin 40 Mg Oral Tablet
40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects
Arms:
Study Group
Placebo
Placebo
Arms:
Control Group
Size
100
Primary endpoint
Incidence of cancer therapy related cardiac dysfunction among the two groups
Six months
Eligibility criteria
Inclusion Criteria: * Female patients diagnosed with histology proven breast cancer with an indication to primary systemic therapy or adjuvant regimens based on anthracyclines Exclusion Criteria: * Patients with impaired LV systolic function (EF below 50%) * Patients with severe valvular heart disease * Patients previously diagnosed with coronary artery disease * Patients with baseline elevated liver enzymes * Patients with prior chemotherapy or radiation therapy * Pregnant females
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Single blind', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-04-06

1 organization

1 product

1 indication

Organization
Ain Shams University
Product
Atorvastatin
Indication
Doxorubicin-induced cardiomyopathy