Comparison of the effects of high-dose atorvastatin and high-dose rosuvastatin on lipid profiles in STEMI patients
Design
Patients were divided into two groups, one receiving high-dose atorvastatin and one high-dose rosuvastatin, both of which were standard MI treatments, and the effects of these two drugs on lipid profile were compared. Two parallel groups, non-blind, non-specific randomization
Settings and conduct
Patients undergoing PCI during the first 6 hours of STEMI (for the first time) patients admitted to the Emam Reza and Ghaem Hospital Emergency were measured on admission after receiving one month of high-dose autorvastatin or high-dose rosuvastatin. lipid profiles were measured and the effects of these two drugs on lipid profiles were compared.
Participants/Inclusion and exclusion criteria
STEMI patients (for the first time) undergoing PCI for the first 6 hours and
Aged between 18 and 65 years old with informed consent to enter the research.
Previous users of statin and those with a previous history of cardiac surgery and those who were candidates for CABG after PCI were excluded.
Intervention groups
Patients were divided into two groups , one group receiving high-dose atorvastatin and one high-dose rosuvastatin , both of which were standard MI treatments.
Main outcome variables
Effectiveness of high dose statin therapy on lipid profile in STEMI patients and comparison of the effect of high-dose atorvastatin and high-dose rosuvastatin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191217045767N1
Registration date:2020-10-11, 1399/07/20
Registration timing:retrospective
Last update:2020-10-11, 1399/07/20
Update count:0
Registration date
2020-10-11, 1399/07/20
Registrant information
Name
Alireza Sabour Hasanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3893 5179
Email address
alirezasabour8895@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-21, 1398/09/30
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
2019-12-21, 1398/09/30
Actual recruitment end date
2020-02-19, 1398/11/30
Trial completion date
2020-02-19, 1398/11/30
Scientific title
Comparison of the effects of high-dose atorvastatin and high-dose rosuvastatin on lipid profile in STEMI patients
Public title
Effects of statin on lipid profile in STEMI patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
STEMI patients (for the first time) who receive Primary PCI within the first 6 hours
Age range 18 to 65 years
Consent to enter the research project and complete the informed consent form
Exclusion criteria:
Previous history of statin use
Patients with a previous history of cardiac surgery
Patients who subsequently undergo PCI have been nominated for CABG
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
92
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Third Floor, No. 23, 4 Sayyad Shirazi Street, Vakil Abad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9188993547
Approval date
2019-08-04, 1398/05/13
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.301
Health conditions studied
1
Description of health condition studied
hyperlipidemia-acute myocardial infarction
ICD-10 code
121
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
lipid Profile (LDL, HDL, Total Cholesterol, Triglyceride)
Timepoint
At baseline and one month later
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Atorvastatin 80 mg daily
Category
Treatment - Drugs
2
Description
Intervention group: Rosuvastatin 40 mg daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of Mashhad
Full name of responsible person
Ali Eshraqi
Street address
Imam Reza Square
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
support@rpsi.ir
2
Recruitment center
Name of recruitment center
Ghaem Hospital of Mashhad
Full name of responsible person
Ramin Khamenei Bagheri
Street address
Ahmad Abad Street
City
mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 7451
Email
ghaemhospital@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Eshraqi
Street address
Third Floor-Plaque23- Sayyad Shirazi4-Vakil Abad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9188993547
Phone
+98 51 3893 5179
Email
alirezasabour8895@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Mashhad University of Medical Sciences
Full name of responsible person
Ali Eshraqi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Third Floor- Plaque23-Sayyad St. Shirazi4-Vakil Abad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9188993547
Phone
+98 51 3893 5179
Email
alirezasabour8895@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Eshraqi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Third Floor-Plaque23- Sayyad St. Shirazi4-Vakil Abad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9188993547
Phone
+98 51 3893 5179
Email
alirezasabour8895@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Eshraqi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Third Floor- Plaque23-Sayyad St. Shirazi4-Vakil Abad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9188993547
Phone
+98 51 3893 5179
Email
alirezasabour8895@yahoo.com
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
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable people
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For further research and studies
From where data/document is obtainable
Keep in touch with alirezasabour8895@yahoo.co
What processes are involved for a request to access data/document
After the request has been submitted by the applicant, it is first reviewed and responded to via email