Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02015988
Status:
UNKNOWN
Last Update Posted:
2016-08-04
First Post:
2013-12-14
Brief Title:
Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome
Sponsor:
Koval O MD
Organization:
Dnipropetrovsk State Medical Academy
Study Overview
Official Title:
Effectiveness and Tolerability of Early Initiation of Combined Lipid -Lowering Therapy Included Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus Hypertriglyceridemia and Acute Coronary Syndrome
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
ACTIVE_NOT_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:
To test the hypothesis that early within 5-21 days after index event administration of combined lipid-lowering therapy in extremely high risk population of patients with type 2 diabetes mellitus T2DM and hypertriglyceridemia HTG who experienced acute coronary syndrome ACS will be effective and well tolerated in achievement of contemporary strict requirements for triglyceride TG levels as an independent risk factor in the case of HTG with diabetes
Detailed Description:
The primary objective of this parallel group study is to demonstrate that the combined therapy of simvastatin and fenofibrate is superior compared to monotherapy with simvastatin based on the comparisons of change of TG levels after 12 weeks of treatment compared to baseline
Secondary objectives are to compare both treatment alternatives the combination therapy of simvastatin and fenofibrate to simvastatin monotherapy with respect to achievement the European Society of Cardiology 2011 ESC 2011 non-HDL-C target less than 26 mmoll change of apolipoprotein Bapolipoprotein A1 apoBapoA1 ratio High-Density Lipoprotein-Cholesterol HDL-C Low-Density Lipoprotein-Cholesterol LDL-C and Uric Acid UA after 12 weeks and 52 weeks 1 year of treatment compared to baseline
Secondary objectives are to compare both treatment alternatives the combination therapy of simvastatin and fenofibrate to simvastatin monotherapy with respect to achievement the European Society of Cardiology 2011 ESC 2011 non-HDL-C target less than 26 mmoll change of apolipoprotein Bapolipoprotein A1 apoBapoA1 ratio High-Density Lipoprotein-Cholesterol HDL-C Low-Density Lipoprotein-Cholesterol LDL-C and Uric Acid UA after 12 weeks and 52 weeks 1 year of treatment compared to baseline
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