Regarding the antiplatelet effect of omega-3 polyunsaturated fatty acids and the potential role of platelet inhibitor drugs in the prevention of cardiovascular events after vascular stenting interventions, in this study, we aimed to assess the effect of omega-3 in the prevention of 30-days major adverse cardiovascular events following Carotid Stenting. Sixty patients candidate of carotid stenting with the ages of 18 to 80 years will be randomly assigned into two groups. The patients with unsatisfactory carotid artery stenting; treatment with glycoprotein IIb/IIIa antagonists or bivalirudin; active bleeding; sensitivity or tolerance to aspirin or clopidogrel or omega-3; and history of percutaneous intervention or coronary artery bypass grafting surgery within 30 days of carotid stenting will be excluded from the study. The intervention group will receive 3g single dose of omega-3, 12 hrs before intervention plus standard treatment before carotid stenting (clopidogrel+ASA) whereas the control group will just receive the standard regimen. Occurrence of major adverse cardiovascular events (stroke, myocardial infarction, revascularization, death) will be assessed during 30-days after intervention as a primary outcome. Only analysts are blinded in this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011120441N6
Registration date:2017-01-24, 1395/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-24, 1395/11/05
Registrant information
Name
Farzaneh Foroughinia
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3635 9357
Email address
foroughinia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-01-14, 1394/10/24
Expected recruitment end date
2017-11-14, 1396/08/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of omega 3 in the prevention of major adverse cardiovascular events
Public title
Effect of omega 3 in the prevention of 30-days major adverse cardiovascular events following Carotid Stenting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing carotid stenting (more than 50% stenosis of the internal carotid artery in symptomatic patients, or 70% stenosis in asymptomatic patients); The ages of 18 to 80 years
Exclusion criteria: Unsatisfactory carotid artery stenting; Intraluminal thrombus over the stenosis; pretreatment with glycoprotein IIb/IIIa antagonists or bivalirudin; Active bleeding; Sensitivity or tolerance to aspirin or Clopidogrel or omega-3; Sever adverse effects to drugs; Percutaneous
intervention or surgery less than 30 days
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy for research, Central building of Shiraz University of Medical Sciences, Zand avenue, Shiraz,
Street address
Shiraz University of Medical Sciences, Deputy for research
City
Shiraz
Postal code
Approval date
2016-04-10, 1395/01/22
Ethics committee reference number
IR.SUMS.REC.1395.6
Health conditions studied
1
Description of health condition studied
Cerebrovascular diseases
ICD-10 code
I65.2
ICD-10 code description
Occlusion and stenosis of carotid artery
Primary outcomes
1
Description
Major adverse cardiovascular events (MACE)
Timepoint
30 days after carotid stenting
Method of measurement
Following patients by phone
Secondary outcomes
1
Description
stroke
Timepoint
24-hrs following carotid stenting
Method of measurement
MRI
Intervention groups
1
Description
Standard treatment before carotid stenting (clopidogrel+ASA) plus 3gr single dose of omega 3 soft gel at least 12 hours before carotid stenting
Category
Prevention
2
Description
Standard treatment (clopidogrel+ASA) before carotid stenting