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临床试验/NCT01723345
NCT01723345Unknown3 期

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

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

farzaneh foroughinia

phD of clinical pharmacy

Shiraz University of Medical Sciences

研究点 (1)

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