Coronary ArteriosclerosisPhase 3NCT01521845
Study of the Effect of omega3 on Biomarkers of Cardiac Necrosis (CKMB and Troponin I) and Inflammation Marker (CRP) After Elective Percutaneous Coronary Intervention (PCI)
A Phase 3 study testing omega 3 in people with Coronary Arteriosclerosis, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to investigate the effect of omega 3 on biomarkers of cardiac necrosis(CKMB and troponin I) and inflammation marker CRP. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- omega 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteIran
- Study dates
- Jan 2012to May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- candidate of elective PCI
- treatment with aspirin at least 5 days before PCI
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of Poly Unsaturated Fatty Acids of Omega 3 as an Anti Platelet Agent on Biomarkers of Cardiac Necrosis Including CKMB and Troponin I and Inflammation Marker CRP
The purpose of this study is to investigate the effect of omega 3 on biomarkers of cardiac necrosis(CKMB and troponin I) and inflammation marker CRP.
Read the detailed description
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 biomarkers of cardiac necrosis (CKMB and troponin I) 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). Blood samples will be drawn in all patients before and 8 and 24 h after intervention for cardiac biomarkers assessment (CK-MB, troponin I)and inflammation marker C-reactive protein (CRP). Major adverse cardiac events (MACE) will be evaluated as a second endpoint.
- Conditions
- Coronary Arteriosclerosis
- Being tested
- omega 3
- Keywords
- elective percutaneous coronary intervention, hs-CRP, CKMB and troponin I
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega 3Drug
Also called fish oil
3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
| Study group | Role | What they receive |
|---|---|---|
| omega 3 | Active comparator | receive omega 3 in addition to standard treatment Receives: Drug: omega 3 |
| control | No intervention | This group is without omega 3 : just receives standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Necrosis Biomarkers (CKMB, Troponin I)
difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention
Measured: 8 and 24 hrs after percutaneous coronary intervention
Inflammation Marker (CRP)
difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention
Measured: 8 and 24 hrs after percutaneous coronary intervention
Secondary outcomes (1)
MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamshid Salamzadeh, PhD, Shahid Beheshti University of Medical Sciences
- Investigators
- Jamshid Salamzadeh, PhD, Principal investigator, SBMU School of Pharmacyfarzaneh foroughinia, phD, Study director, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521845
- Sponsor's protocol ID
- 90-1-94-8048
- Status last verified
- Dec 2012
- First submitted
- 19 Jan 2012
- Last updated
- 10 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Foroughinia F, Salamzadeh J, Namazi MH. Protection from procedural myocardial injury by omega-3 polyunsaturated fatty acids (PUFAs): is related with lower levels of creatine kinase-MB (CK-MB) and troponin I? Cardiovasc Ther. 2013 Oct;31(5):268-73. doi: 10.1111/1755-5922.12016.
PubMed 23134549
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Poly Unsaturated Fatty Acids of Omega 3 as an Anti Platelet Agent on Biomarkers of Cardiac Necrosis Including CKMB and Troponin I and Inflammation Marker CRP
- ClinicalTrials.gov ID
- NCT01521845
- Acronym / sponsor ID
- 90-1-94-8048
- Conditions
- Coronary Arteriosclerosis
- Keywords
- elective percutaneous coronary intervention, hs-CRP, CKMB and troponin I
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Posted 9 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of omega 3 on biomarkers of cardiac necrosis(CKMB and troponin I) and inflammation marker CRP.
Detailed description
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 biomarkers of cardiac necrosis (CKMB and troponin I) 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). Blood samples will be drawn in all patients before and 8 and 24 h after intervention for cardiac biomarkers assessment (CK-MB, troponin I)and inflammation marker C-reactive protein (CRP). Major adverse cardiac events (MACE) will be evaluated as a second endpoint.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega 3 | Active comparator | Drug: omega 3receive omega 3 in addition to standard treatment |
| control | No intervention | –This group is without omega 3 : just receives standard treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- candidate of elective PCI
- treatment with aspirin at least 5 days before PCI
Key exclusion criteria (8 listed)
- high CKMB and troponin I level
- cardiac bypass in recent 3 months
- platelet count < 70×10 9/L
- sever chronic renal failure
- active bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega 3Also: fish oil3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI | Drug | omega 3 |
Primary outcome
Cardiac Necrosis Biomarkers (CKMB, Troponin I)
Time frame: 8 and 24 hrs after percutaneous coronary intervention
difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention
Inflammation Marker (CRP)
Time frame: 8 and 24 hrs after percutaneous coronary intervention
difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention
1 secondary outcome
MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23134549Foroughinia F, Salamzadeh J, Namazi MH. Protection from procedural myocardial injury by omega-3 polyunsaturated fatty acids (PUFAs): is related with lower levels of creatine kinase-MB (CK-MB) and troponin I? Cardiovasc Ther. 2013 Oct;31(5):268-73. doi: 10.1111/1755-5922.12016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamshid Salamzadeh, PhD principal investigator
SBMU School of Pharmacy
farzaneh foroughinia, phD study director
Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing omega 3 in people with Coronary Arteriosclerosis, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Necrosis Biomarkers (CKMB, Troponin I) (time frame: 8 and 24 hrs after percutaneous coronary intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01521845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2012.