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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Coronary Arteriosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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omega 3

receive omega 3 in addition to standard treatment

Group Type ACTIVE_COMPARATOR

omega 3

Intervention Type DRUG

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

control

just receive standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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omega 3

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

Intervention Type DRUG

Other Intervention Names

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fish oil

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No