Comparison the effect of atrovastatin and rosuvastatin on 25-hydroxy vitamin D level in patients with acute myocardial infarction
Design
Clinical trial, block Randomization, parallel groups, blinded outcome, 40 patients in each group, phase 4
Settings and conduct
Patients with acute myocardial infarction are referred to Neyshabur 22 Bahman Hospital, the heart center of the city. After being diagnosed by a cardiologist, they are randomly assigned to one of two study groups and their recommended anti-lipid treatment begins. Blood samples are taken immediately after admission, 12 hours after and 2 weeks after the patient.
Participants/Inclusion and exclusion criteria
Acute Myocardial Infarction Patients Based on ECG Findings, Laboratory Results, and Chest Pain
Intervention groups
One group atrovastatin tablets and the other group rosuvastatin.
Main outcome variables
25-hydroxy vitamin D level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190902044673N1
Registration date:2019-11-07, 1398/08/16
Registration timing:retrospective
Last update:2019-11-07, 1398/08/16
Update count:0
Registration date
2019-11-07, 1398/08/16
Registrant information
Name
Hasan Ghodsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4263 2470
Email address
ghodsih1979@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2017-02-19, 1395/12/01
Actual recruitment end date
2019-01-05, 1397/10/15
Trial completion date
2019-01-05, 1397/10/15
Scientific title
Comparison of the effect of Atorvastatin and rosuvastatin Treatment on the Levels of 25 Hydroxyvitamin D in patient with acute coronary syndrome
Public title
The effect of Atorvastatin and rosuvastatin on the Levels of 25 Hydroxyvitamin D
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute Coronary Syndrome with: chest pain, ECG ST elevation and Troponin Enzyme rising
Exclusion criteria:
Diabetes Mellitus
Take anti-lipid drugs during three past months
Age
From 18 years old to 75 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will prepare 4 leaves that are typed on the two leaves of the letter A (atrostatin) and on the other two leaves of the letter R (rosuvastatin) and draw one card for each patient, without the card being drawn. Insert. At the end of each block we have an equal number of people who received treatment A or treatment R. This process continues until the patient has been included in the study as a sample size. To make our randomization process unpredictable, we use a person (the secretary) to make this assignment and provide conditions for both the patient and the physician to determine the size of the block and the type of treatment received. Be aware and blindness will occur. If each drug contains 60 similar packages, only the letters A for atrostatin and R for rosuvastatin are written on the packaging, and only by the researcher himself. It will know the contents of the packaging and the type of medication.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the patient and the physician are not aware of medications and their sequences and so blindness is occurred.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Neyshabur University of Medical Sciences
Street address
Janbazan Blvd- Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9315833333
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
Ir.nums.rec.1394.19
Health conditions studied
1
Description of health condition studied
Patient with Acute Coronary Syndrome
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
25-hydroxy vitamin D level
Timepoint
At the beginning ,the first 24 hours of hospitalization, two months after admission
Method of measurement
25-hydroxy vitamin D level in blood
Secondary outcomes
empty
Intervention groups
1
Description
The first group of intervention: These patients were randomly subjected to either a single dose of 80 mg Atorvastatin as a secondary prevention treatment plus a routine treatment regimen for 8 weeks at nights. In total, 10 ml blood samples were taken at the time of admission to the emergency department; moreover, 10 ml fasting blood samples were collected within the first 24 h and 2 months after the patients were admitted to the hospital. In addition, blood samples were analyzed for biochemical parameters.
Category
Treatment - Drugs
2
Description
The second group of intervention: These patients were randomly subjected to either a single dose of 40 mg Rosuvastatin as a secondary prevention treatment plus a routine treatment regimen for 8 weeks at nights. In total, 10 ml blood samples were taken at the time of admission to the emergency department; moreover, 10 ml fasting blood samples were collected within the first 24 h and 2 months after the patients were admitted to the hospital. In addition, blood samples were analyzed for biochemical parameters.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman -Neyshabur Hospital
Full name of responsible person
Samaneh Tabaei
Street address
22 Bahman Hospital- Emam Khomeini Ave
City
Neyshabur
Province
Razavi Khorasan
Postal code
9315833333
Phone
+98 51 4333 5620
Email
ghodsih1979@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Seyyed Morteza Shamshirgaran
Street address
Janbazan Blvd- Health faculty
City
Neyshabur
Province
Razavi Khorasan
Postal code
9315833333
Phone
+98 51 4263 2470
Email
sci@nums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour 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
Neyshabour University of Medical Sciences
Full name of responsible person
Samaneh Tabaei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Janbazan Blvd
City
Neyshabur
Province
Razavi Khorasan
Postal code
9315833333
Phone
+98 51 4263 2470
Email
tabaees79@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Samaneh Tabaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Janbazan Blvd
City
Neyshabur
Province
Razavi Khorasan
Postal code
9315833333
Phone
+98 51 4263 2470
Email
tabaees79@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Hasan Ghodsi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Janbazabn Blvd
City
Neyshabur
Province
Razavi Khorasan
Postal code
9315833333
Phone
+98 51 4263 2470
Email
ghodsih1979@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD