Effect of Atorvastatin versus Rosuvastatin on level of inflammatory markers and low density lipoprotein-cholesterol (LDL) in Patients with acute coronary syndrome: double blind randomize control trial
Comparison of the effect of atrovstatin and rosuvastatin on the level of inflammatory markers
Design
double blind randomize control trial, parallel group trial with blinded outcome assessment.
Settings and conduct
Eighty-four patients with acute coronary syndrome will be selected for study at CCU 22 Bahman Neyshabur Hospital. Before starting the study, sampling will be done, then patients will be randomly assigned to receive a single dose of 40 mg rosuvastatin or atrostatin 80 mg daily after dinner plus a routine treatment regimen. The drugs are encoded and encoded by the secretary inside the same envelopes, and all researchers, doctors, staff and nurses and the Committee on Safety and Security are unaware of the contents of the envelopes. Blood samples are taken two months after the patients and evaluated for inflammatory markers.
Participants/Inclusion and exclusion criteria
Diagnosis of acute coronary syndrome based on clinical signs and ECG and serum markers
Factors Affecting Inflammation and Lipid Profile
Intervention groups
In one group of patients atrovstatin (80mg) and in the other group rosovastatin (40mg) Prescribed
Effect of Atorvastatin versus Rosuvastatin on level of inflammatory markers and low density lipoprotein-cholesterol (LDL) in Patients with acute coronary syndrome: double blind randomize control trial
Public title
statin and inflamation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute coronary syndrome based on clinical signs and ECG and serum markers
Exclusion criteria:
renal failure
Liver failure
Immunosuppressants, corticosteroids or potent inhibitors of cytochrome P450 3A4, pentoxifylline, silostazole, glucosamine, berberine barberry extract
Having underlying inflammatory or infectious diseases
Left Schiff's Leukostosis
TG>400
CHF with NYHA III or IV
Having a history of diseases that cause malabsorption syndromes
Uncontrolled blood pressure
Evidence of endocrine or metabolic disease affecting lipid profile
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects with inclusion criteria were randomly divided into two groups: atrostatin and rosuvastatin. For this purpose, we randomly divide the participants into atrostatin and simvastatin groups using 4-way randomized blockade. In this study, we will prepare four 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.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, atrovstatin and rosuvastatin are poured into similar envelopes by a secretary and then coded, envelopes are coded, patients are assigned an envelope in order of study, and the envelope code is recorded for each patient. Participants, all researchers, other cardiologists, CCU nurses and cardiologists, laboratory staff, data collectors, patients with phone calls for follow-up, and the Committee on Safety and Data Monitoring, and The person drafting the article is not aware of the contents of the envelopesatment received and face blindness
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Neyshabour University of Medical Sciences
Street address
University Pardis, Shen Shui Street,
City
Neyshabur
Province
Razavi Khorasan
Postal code
9319116911
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
Ir.nums.rec.1394.22
Health conditions studied
1
Description of health condition studied
Levels of inflammatory markers
ICD-10 code
ICD-10 code description
موضوع مطالعه یک بیماری نیست
Primary outcomes
1
Description
blood levels of inflammatory markers
Timepoint
Before starting the study and 60 days later beginning
Method of measurement
Laboratory measurement by ELISA
Secondary outcomes
1
Description
Lipid profile
Timepoint
Before the intervention and at the end of the intervention
Method of measurement
Laboratory measurement with Pars test kit with Autoanalyzer bt 3000
2
Description
Blood levels of inflammatory markers
Timepoint
Before the intervention and at the end of the intervention
Method of measurement
Laboratory tests
Intervention groups
1
Description
Intervention group: atrovastetin is a drug manufactured by Abidi Pharmaceutical Company at a dose of 80 mg once daily after dinner for 60 days.
Category
Treatment - Drugs
2
Description
Intervention group: Rosvastatin is a drug manufactured by Abidi Pharmaceutical Company at a dose of 40 mg once daily after dinner for 60 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Seyedeh Samaneh Tabaee
Street address
Emam khomeini
City
Neyshabur
Province
Razavi Khorasan
Postal code
9313798999
Phone
+98 51 4333 8153
Email
tabaees@nums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Dr Morteza Shamshirgaran
Street address
Emam Khomeini
City
Neyshabour
Province
Razavi Khorasan
Postal code
9313798999
Phone
+98 51 4330 6210
Email
shamshirgaranm1@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
Seyedeh Samaneh Tabaee
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
No. 7, Between Farhang 2&4, , Farahbakhsh gharbi, Neyshabour
City
Neyshabour
Province
Razavi Khorasan
Postal code
93191169111
Phone
0985142255524
Email
tabaees@nums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Seyedeh Samaneh Tabaee
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
No. 7, Between Farhang 2&4, , Farahbakhsh gharbi, Neyshabour
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319116911
Phone
+98 51 4225 5524
Email
tabaees@nums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Seyedeh Samaneh Tabaee
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
No. 7, Between Farhang 2&4, , Farahbakhsh gharbi, Neyshabour
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319116911
Phone
+98 51 4225 5524
Email
tabaees@nums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available