Coronary Arteriosclerosis Clinical Trial
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
Verified date | December 2012 |
Source | hahid Beheshti University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Moddaress Hospital | Tehran |
Lead Sponsor | Collaborator |
---|---|
hahid Beheshti University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac Necrosis Biomarkers (CKMB, Troponin I) | difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention | 8 and 24 hrs after percutaneous coronary intervention | No |
Primary | Inflammation Marker (CRP) | difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention | 8 and 24 hrs after percutaneous coronary intervention | No |
Secondary | MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death | 30 days | No |
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