Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054938
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2003-02-13
Brief Title:
Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis SLE
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A Randomized Controlled Trial of Strategies for the Prevention of Accelerated Atherosclerosis in Systemic Lupus Erythematosus - A Pilot Study
Status:
COMPLETED
Status Verified Date:
2013-12
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:
None
Brief Summary:
The purpose of this study is to find the best way to prevent heart disease and stroke in people with lupus systemic lupus erythematosis or SLE The study will evaluate the effectiveness of medication and a phone-based education program in controlling four risk factors for heart disease smoking obesity high blood pressure and inactivity The study will also test the safety of commonly used heart medications in people with lupus
Detailed Description:
People with SLE are at much higher risk for mortality due to atherosclerotic vascular disease ASVD Available data suggest that the usual mechanics of and risk factors for atherosclerosis are enhanced by factors such as corticosteroid use and SLE itself This study will evaluate a medication and education program designed to prevent ASVD complications primary prevention or their recurrence secondary prevention The study will also measure the compliance and retention rate for the prevention program over 4 years
Participants in this study will be randomized to receive either preventive heart disease medications or placebo Participants in the medication arm will receive pravastatin alone or in combination with the following aspirin ramipril or a combination of vitamins B6 B12 and folate All participants in this study will receive basic education on how to optimize their heart health Educational material will be sent to the patients as well as to support persons whom they have named One group will receive tailored education based on a particular risk factor Participants will have three study visits and follow-up telephone visits four times a year Study visits will include a medical history and basic laboratory blood tests Participants with documented high blood pressure will receive a home monitoring unit and be asked to monitor their blood pressure Participants will be followed for 2 to 4 years
Participants in this study will be randomized to receive either preventive heart disease medications or placebo Participants in the medication arm will receive pravastatin alone or in combination with the following aspirin ramipril or a combination of vitamins B6 B12 and folate All participants in this study will receive basic education on how to optimize their heart health Educational material will be sent to the patients as well as to support persons whom they have named One group will receive tailored education based on a particular risk factor Participants will have three study visits and follow-up telephone visits four times a year Study visits will include a medical history and basic laboratory blood tests Participants with documented high blood pressure will receive a home monitoring unit and be asked to monitor their blood pressure Participants will be followed for 2 to 4 years
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 |
|---|---|---|---|
| P60AR047782 | NIH | None | httpsreporternihgovquickSearchP60AR047782 |