Does Omega-3 Polyunsaturated Fatty Acids (PUFAs) Pretreatment Improve Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI)?
Primary Purpose
Coronary Arteriosclerosis
Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
omega 3
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Arteriosclerosis focused on measuring elective percutaneous coronary intervention, omega 3 polyunsaturated fatty acids (PUFAs), short-term MACE, long-term MACE
Eligibility Criteria
Inclusion Criteria:
- candidate of elective PCI
- Treatment with aspirin at least 5 days before PCI
Exclusion Criteria:
- high CKMB and troponin I level
- cardiac bypass in recent 3 months
- platelet count < 70×10 9/L
- sever chronic renal failure
- active bleeding
- treatment with glycoprotein IIb/IIIa inhibitors during PCI
- treatment with bivalirudin during PCI
- sensitivity to aspirin and clopidogrel
Sites / Locations
- Moddaress HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
omega 3
control
Arm Description
receive omega 3 in addition to standard treatment
just receive standard treatment
Outcomes
Primary Outcome Measures
short-term MACE
difference between study and control group in 30-days major adverse cardiac events in patients undergoing PCI.
long-term MACE
difference between study and control group in one-year major adverse cardiac events in patients undergoing PCI.
Secondary Outcome Measures
Full Information
NCT ID
NCT01723345
First Posted
November 5, 2012
Last Updated
January 26, 2013
Sponsor
Shiraz University of Medical Sciences
Collaborators
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01723345
Brief Title
Does Omega-3 Polyunsaturated Fatty Acids (PUFAs) Pretreatment Improve Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI)?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences
Collaborators
Shahid Beheshti University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
Percutaneous coronary intervention (PCI) has become the most common form of coronary revascularization worldwide. Although PCI is a safe procedure, it may have multiple risks including bleeding, coronary dissection, abrupt vessel closure, and myocardial necrosis. It is estimated that approximately 25% of patients undergoing PCI have significant postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations and approximately 50% of patients have significant post-procedural troponin elevations. Initially, it was felt these elevations were simple enzyme leaks with no long-term implications.
Now, several studies have demonstrated that periprocedural infarction is associated with short-, intermediate-, and long-term adverse outcomes, most notably mortality. Pretreatment with antiplatelets such as aspirin and clopidogrel play an important role in reducing cardiovascular events (CV events) following PCI.
Omega -3 polyunsaturated fatty acids (PUFAs) have antiplatelet effect. It may also improve response to aspirin and clopidogrel in low-response patients.
This study is a randomized clinical trial (RCT) evaluating the effect of omega 3 supplement [with 400mg Eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA)] on short-term (within 30 days) and long-term (after one year) major adverse cardiac events (MACE) in patients undergoing elective PCI. Eighty patients planed to do elective PCI will be categorized into two groups. The first group will be received standard regimen for PCI (aspirin, clopidogrel, and heparin) and the second group will be treated with standard regimen in addition to 3 gram omega 3 (12 hours before PCI). The main end point of the trial was short-term (within 30-days) and long-term (after one year) incidence of MACE (death, myocardial infarction, or unplanned revascularization).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis
Keywords
elective percutaneous coronary intervention, omega 3 polyunsaturated fatty acids (PUFAs), short-term MACE, long-term MACE
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
omega 3
Arm Type
Active Comparator
Arm Description
receive omega 3 in addition to standard treatment
Arm Title
control
Arm Type
No Intervention
Arm Description
just receive standard treatment
Intervention Type
Drug
Intervention Name(s)
omega 3
Other Intervention Name(s)
fish oil
Intervention Description
3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
Primary Outcome Measure Information:
Title
short-term MACE
Description
difference between study and control group in 30-days major adverse cardiac events in patients undergoing PCI.
Time Frame
30 days
Title
long-term MACE
Description
difference between study and control group in one-year major adverse cardiac events in patients undergoing PCI.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
candidate of elective PCI
Treatment with aspirin at least 5 days before PCI
Exclusion Criteria:
high CKMB and troponin I level
cardiac bypass in recent 3 months
platelet count < 70×10 9/L
sever chronic renal failure
active bleeding
treatment with glycoprotein IIb/IIIa inhibitors during PCI
treatment with bivalirudin during PCI
sensitivity to aspirin and clopidogrel
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
farzaneh foroughinia, phD
Phone
00989177136095
Email
farzanehforoughinia@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
farzaneh foroughinia, phD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
jamshid salamzadeh, phD
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moddaress Hospital
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
farzaneh foroughinia, phD
Phone
oo989177136095
Email
farzanehforoughinia@yahoo.com
First Name & Middle Initial & Last Name & Degree
farzaneh foroughinia, phD
First Name & Middle Initial & Last Name & Degree
jamshid salamzadeh, phD
First Name & Middle Initial & Last Name & Degree
mohammad hasan namazi, MD
12. IPD Sharing Statement
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Does Omega-3 Polyunsaturated Fatty Acids (PUFAs) Pretreatment Improve Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI)?
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