Phase 3
Completed N=104
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)
Coronary Arteriosclerosis
Source: ClinicalTrials.gov NCT01521845 ↗
Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: Cardiac Necrosis Biomarkers (CKMB, Troponin I) — 13; 18 ng/ml — p=0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Necrosis Biomarkers (CKMB, Troponin I) |
13; 18 | 0.001 sig |
| PRIMARY Inflammation Marker (CRP) |
3; 6 | 0.03 sig |
| SECONDARY MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death |
0; 0 | 1 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01521845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.