Clinical trial NCT01723345: Does Omega-3 Polyunsaturated Fatty Acids (PUFAs) Pretreatment Improve Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI)?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Arteriosclerosis
Keywords: elective percutaneous coronary intervention
omega 3 polyunsaturated fatty acids (PUFAs)
short-term MACE
long-term MACE
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2012-11-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: short-term MACE
timeFrame: 30 days
measure: long-term MACE
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Moddaress Hospital
Study officials:
affiliation: Shiraz University of Medical Sciences
name: farzaneh foroughinia, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: jamshid salamzadeh, phD
role: PRINCIPAL_INVESTIGATOR
References: