Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity
NCT ID: NCT05792293
Last Updated: 2023-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2021-06-01
2023-06-30
Brief Summary
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Detailed Description
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They will be divided into 2 groups , the first group will receive 40 mg oral atorvastatin through out the study , while the other group will receive a placebo.
Full echocardiographic study including 3D echocardiography will be done to all patients before starting their chemotherapy and after 6 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Study Group
Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy
Atorvastatin 40 Mg Oral Tablet
40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects
Control Group
Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy
Placebo
Placebo
Interventions
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Atorvastatin 40 Mg Oral Tablet
40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Ahmed Lotfy Mohamed
Principal Investigator
Principal Investigators
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Ahmed L Mohamed, Master
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University
Locations
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Ain Shams University hospitals
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FMASUMD45/2021
Identifier Type: -
Identifier Source: org_study_id
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