Comparison the effects of Atorvastatin and Rosuvastatin in preventing contrast induced nephropathy in myocarial infarction patients underwent primary per-cutaneous coronary intervention
preventing of adverse events helps long-term prognosis of patients with STEMI. In some studies, it is shown that statins can prevent adverse events. however, its has not established significant difference between atorvastatin and rosuvastatin. So, in this study we evaluated the effects of atorvastatin and rosuvastatin in prevention of contrast induced nephropathy. In this clinical trial, of patients referred to Imam Reza and Qaem Hospitals, 200 STEMI patients underwent PPCI and have inclusion criteria were randomly assigned in two groups. In one group, oral atorvastatin with primary dose of 80mg then 40mg twice a day, in another group, rosuvastatin with primary dose of 40mg then 20mg twice a day will administer. After data collection, it will be categorized and will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101236737N1
Registration date:2017-11-19, 1396/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Faeze Keihanian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 292 0581
Email address
keihanianf941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of Atorvastatin and Rosuvastatin in preventing contrast induced nephropathy in myocarial infarction patients underwent primary per-cutaneous coronary intervention
Public title
Comparing the effects of Atorvastatin and Rosuvastatin in preventing acute kidney injury due to contrast media
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: occurrence of first episode of ST elevation Myocardial Infarction (STEMI); performing primary per-cutaneous coronary intervention for patients.
Exclusion criteria: patients under-dialysis; acute kidney injury before angiography; cardiogenic shock; consumption of drugs like N-acetyl cysteine, vitamin C, consumption of venous contrast for other cause, manitol, diuretics, Theophylline and Dopamin in recent two weeks before PCI; having intra-aortic balloon pump; patients with previous cardiac surgery; patients who were candidate for CABG after angioplasty; patients who received G2b3a drugs during PPCI
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Mashhad University of Medical Sciences
Street address
Medical Faculty, University Complex, Azadi Square, Mashhad, Khorasan Razavi
City
Mashhad
Postal code
Approval date
2017-01-25, 1395/11/06
Ethics committee reference number
IR.MUMS.fm.REC.1395.90
Health conditions studied
1
Description of health condition studied
Contrast Induced Nephropathy
ICD-10 code
Y57.5
ICD-10 code description
Other and unspecified drugs and medicament
Primary outcomes
1
Description
Level of serum creatinine
Timepoint
24 hours after intervention and 72 hours after intervention
Method of measurement
mg/ deciliter
Secondary outcomes
1
Description
glumerolar filtration rate
Timepoint
24hours after intervention and 72hours after intervention
Method of measurement
ml/min/1.73 m2
Intervention groups
1
Description
oral atorvastatin 80mg before PPCI then 40mg bid after PPCI
Category
Treatment - Drugs
2
Description
Rosuvastatin 40mg before PPCI then 20mg bid after PPCI