Objective: The effect of combination therapy with Atorvastatin and Aspirin on the severity of fibrosis and liver function in compensated cryptogenic cirrhosis
Study design: Randomized, Double blind, controlled with placebo, single center, Phase 4 trial,
Population study: patient with compensated cryptogenic cirrhosis
Inclusion criteria: patients with compensated cryptogenic cirrhosis; patients living in Qom; Age of 18 to 75 years; patient without another type of cirrhosis; patients that not medicated with statins; patients with serum LDL>70; Patients with PLT>50000
Exclusion criteria: Increased liver enzymes more than three times, three months after treatment; Lack of cooperation in the proper use of drugs; Statin-induced myopathy; use of Fibrates, Erythromycin, and other drugs that suppressed metabolism of p450 liver enzyme
Sample size: 40 patients
Intervention: combination therapy with Atorvastatin and Aspirin and Atorvastatin and placebo in control group
Outcome: severity of liver fibrosis and liver function
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120531252N1
Registration date:2017-02-28, 1395/12/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-28, 1395/12/10
Registrant information
Name
Ahmad Hormati
Name of organization / entity
Qom university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2053
Email address
hormatia@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Office of Research & Technology; Qom University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combination therapy with Atorvastatin and Aspirin on the severity of fibrosis and liver function in compensated cryptogenic cirrhosis
Public title
Effect of Aspirin and Atorvastatin on liver function in patients with hepatic failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with compensated cryptogenic cirrhosis; living in Qom; Age of 18 to 75 years; patient without another type of cirrhosis; who have not been treated with statins; patients with serum LDL>70; Patients with PLT>50000
Exclusion criteria: Increased liver enzymes more than three times, three months after treatment; Lack of cooperation in the proper use of drugs; Statin-induced myopathy; use of Fibrates, Erythromycin, and other drugs that suppressed metabolism of p450 liver enzyme
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Qom, Saaheli Street, Qom University of Medical Sciences
City
Qom
Postal code
3713649373
Approval date
2017-01-18, 1395/10/29
Ethics committee reference number
IR.MUQ.REC.1395.134
Health conditions studied
1
Description of health condition studied
Liver Cirhhosis
ICD-10 code
K72.1
ICD-10 code description
Chronic hepatic failure
Primary outcomes
1
Description
sevirity of fibrosis
Timepoint
six months after begining intervention
Method of measurement
kpa with fibroscan
2
Description
liver function
Timepoint
six months after begining intervention
Method of measurement
child score
Secondary outcomes
1
Description
liver enzymes levels
Timepoint
six month after begining of intervention
Method of measurement
IU/L
Intervention groups
1
Description
Atorvastatin, tab 20 mg oral, once daily, for 6 months along with َAsprin, tab 80 mg Oral, once daily, for six months
Category
Treatment - Drugs
2
Description
Atorvastatin, tab 20 mg, oral, once daily, for 6 months along with placebo (of Aspirin), Oral, once daily, for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology and Hepatology Research Center, Qom University of Medical Sciences
Full name of responsible person
Dr Mansoureh Molaei
Street address
Gastroenterology and Hepatology Disease Research Center, Endoscopy Unit, Shahid Beheshti Hospital Qom, Shahid Beheshti Blv
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Office of Research & Technology, Qom University of Medical Sciences
Full name of responsible person
Fahime Aliabadi
Street address
Namber 83, Alley 4, Alley 1.1, Safashahr Street
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Office of Research & Technology, Qom 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
Qom University of Medical Sciences
Full name of responsible person
Mansoureh Molaei
Position
M.D, Resident of Internal Medicine
Other areas of specialty/work
Street address
Gastroenterology and Hepatology Disease Research Center, Endoscopy Unit, Shahid Beheshti Hospital Qom, Shahid Beheshti Blv