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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Shiraz University of Medical Sciences
Sponsor:
Collaborator:
Shahid Beheshti Medical University
Information provided by (Responsible Party):
farzaneh foroughinia, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01723345
First received: November 5, 2012
Last updated: January 26, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention Phase
Coronary Arteriosclerosis
Drug: omega 3
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • short-term MACE [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    difference between study and control group in 30-days major adverse cardiac events in patients undergoing PCI.

  • long-term MACE [ Time Frame: one year ] [ Designated as safety issue: No ]
    difference between study and control group in one-year major adverse cardiac events in patients undergoing PCI.


Estimated Enrollment: 90
Study Start Date: February 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: omega 3
receive omega 3 in addition to standard treatment
Drug: omega 3
3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
Other Name: fish oil
No Intervention: control
just receive standard treatment

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723345

Contacts
Contact: farzaneh foroughinia, phD 00989177136095 farzanehforoughinia@yahoo.com

Locations
Iran, Islamic Republic of
Moddaress Hospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: farzaneh foroughinia, phD    oo989177136095    farzanehforoughinia@yahoo.com   
Principal Investigator: farzaneh foroughinia, phD         
Principal Investigator: jamshid salamzadeh, phD         
Sub-Investigator: mohammad hasan namazi, MD         
Sponsors and Collaborators
Shiraz University of Medical Sciences
Shahid Beheshti Medical University
Investigators
Principal Investigator: farzaneh foroughinia, phD Shiraz University of Medical Sciences
Principal Investigator: jamshid salamzadeh, phD Shahid Beheshti Medical University
  More Information

No publications provided

Responsible Party: farzaneh foroughinia, phD of clinical pharmacy, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01723345     History of Changes
Other Study ID Numbers: 90-1-94-8048
Study First Received: November 5, 2012
Last Updated: January 26, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by Shiraz University of Medical Sciences:
elective percutaneous coronary intervention
omega 3 polyunsaturated fatty acids (PUFAs)
short-term MACE
long-term MACE

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases

ClinicalTrials.gov processed this record on August 19, 2014