Does Omega-3 Polyunsaturated Fatty Acids (PUFAs) Pretreatment Improve Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI)?
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|ClinicalTrials.gov Identifier: NCT01723345|
Recruitment Status : Unknown
Verified January 2013 by farzaneh foroughinia, Shiraz University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : November 7, 2012
Last Update Posted : January 29, 2013
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).
|Condition or disease||Intervention/treatment||Phase|
|Coronary Arteriosclerosis||Drug: omega 3||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||April 2013|
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
- short-term MACE [ Time Frame: 30 days ]difference between study and control group in 30-days major adverse cardiac events in patients undergoing PCI.
- long-term MACE [ Time Frame: one year ]difference between study and control group in one-year major adverse cardiac events in patients undergoing PCI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University of Medical Sciences|