Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127218
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2005-08-03
Brief Title:
High-Density Lipoprotein HDL Cholesterol Increased Plaque Stabilization in the Elderly
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
HDL Increased Plaque Stabilization in the Elderly
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
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:
NIA-Plaque
Brief Summary:
The purpose of this study is to investigate the added benefits of increased high-density lipoprotein HDL cholesterol serum levels over and above those achieved by lipid lowering therapy guided by current guidelines in older individuals with cardiovascular disease
Detailed Description:
The hypothesis being tested is that the current standard lipid lowering therapy combined with a 20 percent or greater increase in serum HDL induced by long-acting niacin reduces plaque size in older individuals with cardiovascular disease The specific aims of testing this hypothesis are
1 to determine the effects of statin plus placebo vs statin plus niacin therapy on plaque size and composition
2 to determine whether alterations of inflammatory markers of atherosclerosis induced by lipid lowering therapy parallel alterations of plaque architecture and composition in older patients with cardiovascular disease
3 to determine the effects of these interventions on the incidence of cardiovascular and cerebrovascular events
The results of the trial will be directly applicable to developing strategies for plaque stabilization in the elderly who suffer the most from the severe complications of advanced cardiovascular atherosclerosis
A total of 144 participants aged 65 and older with cardiovascular or cerebrovascular disease will be recruited Participants will be randomized to receive either statin plus niacin or statin plus a placebo for 18 months Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily simvastatin 20 mg daily atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily Ten visits are expected initially every 4 weeks for dose adjustment Then visits will be every 6 months MRI Inflammatory Markers tests and other lab tests will be done at baseline and the visits at months 6 12 and 18
1 to determine the effects of statin plus placebo vs statin plus niacin therapy on plaque size and composition
2 to determine whether alterations of inflammatory markers of atherosclerosis induced by lipid lowering therapy parallel alterations of plaque architecture and composition in older patients with cardiovascular disease
3 to determine the effects of these interventions on the incidence of cardiovascular and cerebrovascular events
The results of the trial will be directly applicable to developing strategies for plaque stabilization in the elderly who suffer the most from the severe complications of advanced cardiovascular atherosclerosis
A total of 144 participants aged 65 and older with cardiovascular or cerebrovascular disease will be recruited Participants will be randomized to receive either statin plus niacin or statin plus a placebo for 18 months Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily simvastatin 20 mg daily atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily Ten visits are expected initially every 4 weeks for dose adjustment Then visits will be every 6 months MRI Inflammatory Markers tests and other lab tests will be done at baseline and the visits at months 6 12 and 18
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AG021570-03 | NIH | None | httpsreporternihgovquickSearch5R01AG021570-03 |