Does Omega-3 Polyunsaturated Fatty Acids (PUFAs) Pretreatment Improve Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI)?
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
- short-term MACE [ Time Frame: 30 days ] [ Designated as safety issue: No ]difference between study and control group in 30-days major adverse cardiac events in patients undergoing PCI.
- long-term MACE [ Time Frame: one year ] [ Designated as safety issue: No ]difference between study and control group in one-year major adverse cardiac events in patients undergoing PCI.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Active Comparator: omega 3
receive omega 3 in addition to standard treatment
Drug: omega 3
3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
Other Name: fish oil
No Intervention: control
just receive standard treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723345
|Contact: farzaneh foroughinia, phDfirstname.lastname@example.org|
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Contact: farzaneh foroughinia, phD oo989177136095 email@example.com|
|Principal Investigator: farzaneh foroughinia, phD|
|Principal Investigator: jamshid salamzadeh, phD|
|Sub-Investigator: mohammad hasan namazi, MD|
|Principal Investigator:||farzaneh foroughinia, phD||Shiraz University of Medical Sciences|
|Principal Investigator:||jamshid salamzadeh, phD||Shahid Beheshti Medical University|