Comparing two different doses of Atorvastatin for decrease the level of LDL in ACS patient and its relationship with the polymorphism of MDR1 gene, and determinate the effective dose of drug.
Determine the effective dose of Atorvastatin in the ACS (acute coronary syndrome) patients in Heshmatieh hospital in 1397
Design
Controlled clinical trial, randomized, with out blinding, parallel group, in 86 patients. Randomization was simple.
Settings and conduct
In this study, a population of 86 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 and a sample of blood from patients will be send to examine the MDR1(Multi-Drug Resistance ) gene polymorphism. The intervention group received three months of treatment with 40 mg of atorvastatin daily and the control 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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
Case group: In this group patients will take 40 milligram Atorvastatin daily.
Control group: In this group patients will take 80 milligram Atorvastatin daily.
Main outcome variables
Determine the effective dose of Atorvastatin in ACS (acute coronary syndrome) patients
Determine the amount of reduction of LDL (Low Density Lipoprotein ) in patients with polymorphism in MDR1(Multi-Drug Resistance ) gene.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140921019240N4
Registration date:2018-06-08, 1397/03/18
Registration timing:prospective
Last update:2018-06-08, 1397/03/18
Update count:1
Registration date
2018-06-08, 1397/03/18
Registrant information
Name
Omid Gholami
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4444 6070
Email address
gholamio@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing two different doses of Atorvastatin for decrease the level of LDL in ACS patient and its relationship with the polymorphism of MDR1 gene, and determinate the effective dose of drug.
Public title
Comparing two different doses of Atorvastatin for decrease the level of LDL in ACS patient and its relationship with the polymorphism of MDR1 gene.
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
To 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Ethics committee of Sabzevar University of Medical Sciences, Shohadaie Hastehi Blvd, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.Medsab.Rec.1396.153
Health conditions studied
1
Description of health condition studied
acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified
Primary outcomes
1
Description
Low density lipoprotein
Timepoint
At the start of study & 3 months later
Method of measurement
Blood test
2
Description
MDR1 (Multi-Drug Resistance ) gene polymorphism
Timepoint
At the start of study
Method of measurement
Polymerase Chain Reaction
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: The control group will be treated with atorvastatin 80 mg daily for three months. Atorvastatin product by Abidi Pharmaceutical Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatie hospital
Full name of responsible person
Nafiseh Khalilzadeh
Street address
Sabzevar university of medical science
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8319
Email
nafisekh31@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Omid Gholami
Street address
Sabzevar University of Medical Science, Deputy of Research and Technology of Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1320
Email
omid693@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Nafiseh Khalilzadeh
Position
Student (Intern)
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Sabzevar University Of Medical Science
City
Sabzevar
Province
South Khorasan
Postal code
9617913112
Phone
+98 51 4466 4986
Email
nafisekh31@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Omid Gholami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Sabzevar University of Medical Science
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1320
Email
omid693@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Omid Gholami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Medicine, Deputy of Research and Technology, Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4444 6070
Fax
+98 51 4444 5622
Email
gholamio@medsab.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
After unidentifiable people, you can shared the all of personal data.
When the data will become available and for how long
The start of access period is 6 months after publish results.
To whom data/document is available
Researchers working in academic and scientific institutions and industry workers.
Under which criteria data/document could be used
Using the results of this study with the source is allowed.
From where data/document is obtainable
Dr.Omid Gholami
Sabzevar University of Medical Science
omid693@yahoo.com
What processes are involved for a request to access data/document
We can submit data if a person withe specific organizational affiliation, submit a written request.