- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01723345
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 Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: farzaneh foroughinia, phD
- Phone Number: 00989177136095
- Email: farzanehforoughinia@yahoo.com
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
- Moddaress Hospital
-
Principal Investigator:
- jamshid salamzadeh, phD
-
Contact:
- farzaneh foroughinia, phD
- Phone Number: oo989177136095
- Email: farzanehforoughinia@yahoo.com
-
Principal Investigator:
- farzaneh foroughinia, phD
-
Sub-Investigator:
- mohammad hasan namazi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: omega 3
receive omega 3 in addition to standard treatment
|
3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
Other Names:
|
No Intervention: control
just receive standard treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
short-term MACE
Time Frame: 30 days
|
difference between study and control group in 30-days major adverse cardiac events in patients undergoing PCI.
|
30 days
|
long-term MACE
Time Frame: one year
|
difference between study and control group in one-year major adverse cardiac events in patients undergoing PCI.
|
one year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: farzaneh foroughinia, phD, shiraz University of medical sciences
- Principal Investigator: jamshid salamzadeh, phD, Shahid Beheshti University of Medical Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90-1-94-8048
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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