In this study we investigated the effect of different doses of atorvastatin on plasma concentration of homocysteine in male patients with coronary heart disease. In a double-blind clinical trial conducted from April to September 2007, we enrolled 52 male patients who were hospitalized in Mazandaran heart center due to acute coronary syndrome. Patients with unstable angina, sensitivity to statins, diseases of hepatobiliary system, serum creatinine concentrations ≥175µmol/l (2.0 mg/dl), left anterior descending artery involvement, history of using QT interval prolongation and P450 suppressant drugs and the patients with unreasonable high creatine kinase were excluded. Patients who met including criteria were divided into three groups randomly and they received 20, 40, and 80 mg atorvastatin daily for six months. Laboratory assessments for measuring the level of Homocysteine were done before and 1, 3 and 6 months after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071614018N1
Registration date:2013-08-18, 1392/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-18, 1392/05/27
Registrant information
Name
Safoora Masoumi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1241 4858
Email address
safoora.masoumi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2007-04-01, 1386/01/12
Expected recruitment end date
2007-10-01, 1386/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of different doses of Atorvastatin on Plasma homocysteine levels in male Patients with Coronary Atherosclerosis
Public title
Comparison of the effects of different doses of Atorvastatin on blood homocysteine levels in male Patients with heart disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male; Stable;Acute Coronary Syndrome;Documented atherosclerotic lesions in Angiography ; Refused to do Coronary Artery Bypass Graft or Angioplasty
Exclusion criteris: Female; Unstable Angina; Sensitivity to Statins ; Diseases of hepatobiliary system ; Serum creatinine concentrations ≥175µmol/l (2.0 mg/dl) ; Left anterior descending artery involvement ; History of using QT interval prolongation and P450 suppressant drugs ;
unreasonable high creatine kinase
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Juybar interaction ,Imam square
City
Sari
Postal code
Approval date
2006-06-12, 1385/03/22
Ethics committee reference number
85/3/22
Health conditions studied
1
Description of health condition studied
Ischemic Heart Disease
ICD-10 code
121
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Homocysteine levels
Timepoint
1, 3 and 6 months
Method of measurement
Blood sampling
Secondary outcomes
1
Description
Side effects of drug
Timepoint
1,3,6 months and whenever the patients complaint
Method of measurement
Clinical examination
Intervention groups
1
Description
The second group recieved 80 mg /day Atorvastatin for six months
Category
Treatment - Drugs
2
Description
The first group recievd 20 mg/day Atorvastating for six months
Category
Treatment - Drugs
3
Description
The second group recieved 40 mg/day Atorvastatin for six months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran Heart Center
Full name of responsible person
Dr Keyvan Yousefnejad
Street address
Mazandaran Heart Center, Artesh BLVD
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr yousefnejad
Street address
Deputy of research, Moallem suare, Moallem street
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Safoora Masoumi
Position
MD
Other areas of specialty/work
Street address
Deputy of Research, Moallem square, Moallem street
City
Sari
Postal code
4817844718
Phone
+98 15 1214 4858
Fax
Email
safoora.masoumi@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
safoora Masoumi
Position
MD
Other areas of specialty/work
Street address
Deputy of research , Moallem square
City
Sari
Postal code
Phone
+98 15 1214 4858
Fax
Email
safoora.masoumi@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Safoora Masoumi
Position
MD
Other areas of specialty/work
Street address
Deputy of Research, Moallem Square, Moallem street
City
Sari
Postal code
4817844718
Phone
+98 15 1214 4858
Fax
Email
safoora.masoumi@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)