Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01723345
Status:
UNKNOWN
Last Update Posted:
2013-01-29
First Post:
2012-11-05
Brief Title:
Does Omega-3 Polyunsaturated Fatty Acids PUFAs Pretreatment Improve Outcomes in Patients Undergoing Percutaneous Coronary Intervention PCI
Sponsor:
Shiraz University of Medical Sciences
Organization:
Shiraz University of Medical Sciences
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2013-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CKcreatinine 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None