Does Omega-3 Polyunsaturated Fatty Acids (PUFAs) Pretreatment Improve Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI)?

Coronary Arteriosclerosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01723345
• Other study ID #: 90-1-94-8048
• Status: Recruiting
• Phase: Phase 3
• First received: November 5, 2012
• Last updated: January 26, 2013
• Start date: February 2012
• Est. completion date: April 2013

Study information

• Verified date: January 2013
• Source: Shiraz University of Medical Sciences
• Contact: farzaneh foroughinia, phD
• Phone: 00989177136095
• Email: farzanehforoughinia[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Drug:
• omega 3
3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI

Locations

Country	Name	City	State
Iran, Islamic Republic of	Moddaress Hospital	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences	hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	short-term MACE	difference between study and control group in 30-days major adverse cardiac events in patients undergoing PCI.	30 days	No
Primary	long-term MACE	difference between study and control group in one-year major adverse cardiac events in patients undergoing PCI.	one year	No