Objectives: To assess the effect of atorvastatin on mean platelet volume in new patients with hypercholesterolemia
Design: a before-after clinical trial.
Setting and conduct: The eligible patients with hypercholesterolemia who will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 65 years; new patients with hypercholesterolemia without history of treatment.
Exclusion criteria: Thyroid disorders; hematologic disorders; sepsis; preeclampsia; diabetes; cardiovascular diseases; a history of major surgery or trauma in the past 2 weeks.
Intervention group: Atorvastatin capsule 40 mg daily for 2 months.
Control group: In comparison with before intervention.
Primary outcome: Assessing serum cholesterol before intervention and 2 months later through laboratory test.
Randomization: This is a before after trial without randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706089014N168
Registration date:2017-07-05, 1396/04/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-05, 1396/04/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-12-30, 1395/10/10
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of atorvastatin on mean platelet volume in new patients with hypercholesterolemia: a before-after clinical trial
Public title
Effect of atorvastatin on mean platelet volume in new patients with hypercholesterolemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; new patients with hypercholesterolemia without history of treatment.
Exclusion criteria: Thyroid disorders; hematologic disorders; sepsis; preeclampsia; diabetes; cardiovascular diseases; a history of major surgery or trauma in the past 2 weeks.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: This is a before after trial without randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-12-24, 1395/10/04
Ethics committee reference number
IR.UMSHA.REC.1395.425
Health conditions studied
1
Description of health condition studied
Hypercholesterolemia
ICD-10 code
E78.0
ICD-10 code description
Pure hypercholesterolaemia
Primary outcomes
1
Description
Assessing serum cholesterol
Timepoint
before intervention and 2 months later
Method of measurement
through laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Atorvastatin capsule 40 mg daily for 2 months.
Category
Treatment - Drugs
2
Description
Control group: In comparison with before intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Roya Khazaie
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Roya Khazaie
Position
Medical Student
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
roya.khazaie@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Alireza Rastgoye Haghi
Position
Pathologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
alireza_rh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)