Cardiovascular Outcomes Clinical Trial
Official title:
Benefit of Elevation of HDL-cholesterol/Triglyceride Lowering on Cardiovascular Outcomes in Women
NCT number | NCT01921010 |
Other study ID # | 3954 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 2003 |
Est. completion date | June 2005 |
Verified date | April 2019 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The combination of HDL-C elevation, lowering of triglycerides and further LDL-C reduction
accomplished by the addition of niacin to statin medication would improve endothelial
function as compared to LDL-C reduction alone in patients with and without coronary artery
disease and the combination of low HDL-C/high triglycerides.
The combination of lipid lowering therapy would have beneficial effects on markers of
inflammation. These benefits would be particularly evident in women.
Status | Completed |
Enrollment | 43 |
Est. completion date | June 2005 |
Est. primary completion date | June 2005 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Stable CAD(coronary artery disease) patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl - Well-controlled diabetes with HbA1C < 7.5 currently on statin therapy, able to tolerate Niacin without unstable blood glucose levels with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl - Stable patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl Exclusion Criteria: - History of MI(myocardial infarction), PTCA(percutaneous transluminal coronary angiography) or surgery within previous 3 months - Currently on Niaspan and unwilling to withdraw Niaspan therapy or known intolerance to niacin - Active or known gall bladder disease - Pregnant or nursing women - Significant comorbidity that precludes participation - Significant liver disease, active alcoholism, or LFT(liver function test) >1.5x's ULN( upper limit of normal) at screening - Diabetes with Hg A1C(hemoglobin A1c) < 7.5 - PI perceived inability to comply with protocol |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | endothelial function | 16 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04125212 -
Air Pollution and Cardio-metabolic Health
|
||
Completed |
NCT02601352 -
Air Pollution and Cardiometabolic Study
|
||
Recruiting |
NCT03206593 -
Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure
|
N/A | |
Withdrawn |
NCT02058875 -
Cardiovascular Risk Following Conversion to Full Dose Myfortic® and Neoral® Two-hour Post Level Monitoring
|
Phase 4 | |
Completed |
NCT03899675 -
Impact of Caffeine Intake on Autonomic Parameters in the Exercise of Strength
|
N/A |