Protocol summary
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Study aim
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Determine the effective dose of Atorvastatin in the ACS (acute coronary syndrome) patients in Heshmatieh hospital in 1397
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Design
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Controlled clinical trial, randomized, single blinded, parallel group, in 60 patients. Randomization was simple.
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Settings and conduct
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In this study, a population of 60 ACS (acute coronary syndrome) patients admitted to the CCU (coronary care unit) section of Hashamtayeh Sabzevar Hospital will be studied. So that all patients will be taken of fat profile tests and echocardiography when they are admitted. One group received three months of treatment with 40 mg of atorvastatin daily and the other group will be treated with atorvastatin 80 mg daily for three months. After three months, the patients will be checked twice for a fat profile by referring to the cardiologist and the LDL (Low Density Lipoprotein ) reduction in both groups will be recorded. Ultimately, reduction of LDL cholesterol will be compared in both case and control groups.
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Participants/Inclusion and exclusion criteria
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login: َACS (acute coronary syndrome) patients who are admit in CCU (coronary care unit) in Heshmatie hospital
Exit: The normal coronary patients
The patients who are more than 75 years old
The patients who are using Fibrate drugs in the same time
The patients who are living in the villages and disable for follow up
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Intervention groups
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Case group: In this group patients will take 40 milligram Atorvastatin daily.
Control group: In this group patients will take 80 milligram Atorvastatin daily.
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Main outcome variables
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Determine the effective dose of Atorvastatin in ACS (acute coronary syndrome) patients
Determine the amount of reduction of LDL (Low Density Lipoprotein ) in patients.
General information
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Reason for update
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We deleted the study of MDR1 polymorphism, Because of facing with some problems in the collecting the data. We did this after approving the change in the research council of Sabzevar university of medical sciences.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140921019240N4
Registration date:
2018-06-08, 1397/03/18
Registration timing:
prospective
Last update:
2021-12-07, 1400/09/16
Update count:
1
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Registration date
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2018-06-08, 1397/03/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-06-22, 1397/04/01
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Expected recruitment end date
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2018-12-21, 1397/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing two different doses of Atorvastatin for decrease the level of LDL in ACS patient and determinate the effective dose of drug.
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Public title
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Comparing two different doses of Atorvastatin for decrease the level of LDL in ACS patient.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
َACS (acute coronary syndrom) patients who are admit in CCU (coronary care unit) in Heshmatie hospital
Exclusion criteria:
The normal coronary patients
The patients who are more than 75 years old
The patients who are using Fibrate drugs in the same time
The patients who are living in the villages and disable for follow up
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Age
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To 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization
From the beginning of the study, the names of the patients will be document in the table. The patients with odd number will be in A group and the patients with even number will be in B group.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this one-blind clinical trial, only subjects were unaware of the study procedure.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-02-26, 1396/12/07
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Ethics committee reference number
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IR.Medsab.Rec.1396.153
Health conditions studied
1
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Description of health condition studied
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acute coronary syndrome
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ICD-10 code
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I24.9
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ICD-10 code description
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Acute ischemic heart disease, unspecified
Primary outcomes
1
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Description
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Low density lipoprotein
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Timepoint
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At the start of study & 3 months later
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Method of measurement
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Blood test
2
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Description
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MDR1 (Multi-Drug Resistance ) gene polymorphism
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Timepoint
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At the start of study
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Method of measurement
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Polymerase Chain Reaction
Intervention groups
1
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Description
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Intervention group: The intervention group received three months of treatment with 40 mg of atorvastatin daily from the start of study. Atorvastatin product by Abidi Pharmaceutical Company.
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Category
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Treatment - Drugs
2
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Description
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Control group: The control group will be treated with atorvastatin 80 mg daily for three months. Atorvastatin product by Abidi Pharmaceutical Company.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sabzevar University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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After unidentifiable people, you can shared the all of personal data.
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When the data will become available and for how long
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The start of access period is 6 months after publish results.
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To whom data/document is available
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Researchers working in academic and scientific institutions and industry workers.
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Under which criteria data/document could be used
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Using the results of this study with the source is allowed.
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From where data/document is obtainable
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Dr.Omid Gholami
Sabzevar University of Medical Science
omid693@yahoo.com
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What processes are involved for a request to access data/document
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We can submit data if a person withe specific organizational affiliation, submit a written request.
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Comments
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