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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01723345

Enrollment

Registered

2012-11-07

Start date

2012-02-29

Completion date

2013-04-30

Last updated

2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Arteriosclerosis

Keywords

elective percutaneous coronary intervention, omega 3 polyunsaturated fatty acids (PUFAs), short-term MACE, long-term MACE

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).

Interventions

DRUGomega 3

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
short-term MACE	30 days	difference between study and control group in 30-days major adverse cardiac events in patients undergoing PCI.
long-term MACE	one year	difference between study and control group in one-year major adverse cardiac events in patients undergoing PCI.

Countries

Iran

Contacts

Primary Contactfarzaneh foroughinia, phD

farzanehforoughinia@yahoo.com00989177136095

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026