Does Omega-3 Polyunsaturated Fatty Acids (PUFAs) Pretreatment Improve Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI)?
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- short-term MACE
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •candidate of elective PCI
- •Treatment with aspirin at least 5 days before PCI
排除标准
- •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
研究组 & 干预措施
omega 3
receive omega 3 in addition to standard treatment
干预措施: omega 3 (Drug)
结局指标
主要结局
short-term MACE
时间窗: 30 days
difference between study and control group in 30-days major adverse cardiac events in patients undergoing PCI.
long-term MACE
时间窗: one year
difference between study and control group in one-year major adverse cardiac events in patients undergoing PCI.
次要结局
未报告次要终点
研究者
farzaneh foroughinia
phD of clinical pharmacy
Shiraz University of Medical Sciences
