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

NCT01723345 | Unknown Phase 3

• 1 other identifier: 90-1-94-8048
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Arteriosclerosis

Keywords

elective percutaneous coronary intervention; omega 3 polyunsaturated fatty acids (PUFAs); short-term MACE; long-term MACE

Outcome Measures

Primary Outcomes (2)

• short-term MACE

  difference between study and control group in 30-days major adverse cardiac events in patients undergoing PCI.

  30 days

• long-term MACE

  difference between study and control group in one-year major adverse cardiac events in patients undergoing PCI.

  one year

Study Arms (2)

omega 3

ACTIVE COMPARATOR

receive omega 3 in addition to standard treatment

Drug: omega 3

control

NO INTERVENTION

just receive standard treatment

Interventions

omega 3 DRUG

3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI

Also known as: fish oil

omega 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• candidate of elective PCI
• Treatment with aspirin at least 5 days before PCI

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead
• Shahid Beheshti University of Medical Sciences: collaborator

Study Sites (1)

Moddaress Hospital

Tehran, Tehran Province, Iran

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Docosahexaenoic Acids; Fish Oils

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Study Officials

• farzaneh foroughinia, phD

  Shiraz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• jamshid salamzadeh, phD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

farzaneh foroughinia, phD

CONTACT

00989177136095; farzanehforoughinia@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phD of clinical pharmacy

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 7, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

IR (1)