Does Omega-3 Polyunsaturated Fatty Acids (PUFAs) Pretreatment Improve

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01723345
Study type	Interventional
Source	Shiraz University of Medical Sciences
Contact	farzaneh foroughinia, phD
Phone	00989177136095
Email	farzanehforoughinia@yahoo.com
Status	Recruiting
Phase	Phase 3
Start date	February 2012
Completion date	April 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00069654` - Dietary Nitrate and Nitrite to Increase Nitric Oxide in Patients With Coronary Artery Disease	Phase 2
Completed	`NCT02919124` - Epicardial Echocardiography of Coronary Anastomoses Using the Echoclip Device	N/A
Recruiting	`NCT02639962` - Characteristics of Culprit Lesion and Changes in Plaque Composition. A Dual Energy Cardiac CT Study	N/A
Completed	`NCT02494557` - Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients	N/A
Recruiting	`NCT01466452` - Antiplatelet Effect of Low Doses of Aspirin Taken Every 12 Hours in Patients Undergoing Coronary Artery Bypass Graft and/or Aortic Valve Surgery	Phase 2
Completed	`NCT01182428` - XIENCE V: SPIRIT WOMEN Sub-study	Phase 4
Completed	`NCT00368953` - YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus	Phase 4
Completed	`NCT00371891` - Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)	Phase 4
Completed	`NCT00319449` - Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)	Phase 4
Completed	`NCT00091754` - Atherosclerosis, Plaque and CVD in Communities
Completed	`NCT00069797` - Epidemiology of Coronary Heart Disease in Men Aged 40 and Over	N/A
Completed	`NCT00037245` - Androgens and Subclinical Atherosclerosis in Young Women - Ancillary to CARDIA	N/A
Completed	`NCT00024596` - Family Heart Study - Subclinical Atherosclerosis Network (FHS-SCAN)	N/A
Completed	`NCT00006502` - Myocardial Perfusion, Risk Factors, and Coronary Calcium	N/A
Withdrawn	`NCT00006497` - Long-Term Effects of Subclinical CAD on Cardiac Function
Completed	`NCT00006407` - Sex Steroid Hormones and Risk of CHD in Women	N/A
Completed	`NCT00006309` - Pooling of Cohort Studies on Diet & Coronary Disease	N/A
Completed	`NCT00005269` - Family Blood Pressure Program - GENOA
Completed	`NCT00000508` - Stanford Coronary Risk Intervention Project (SCRIP)	Phase 3
Completed	`NCT00005147` - Epidemiology of Atherosclerosis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms