Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632379
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Sponsor:
None
Organization:
None
Study Overview
Official Title:
AtorvaStatin Postpartum and Reduction of Cardiovascular risK SPARK A Randomized Placebo-controlled Trial of Atorvastatin Postpartum for Reduction of Cardiovascular Risk
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARK
Brief Summary:
The objective is to conduct a double-blinded randomized controlled trial of atorvastatin vs placebo among postpartum individuals with hypertensive disorders of pregnancy to improve cardiovascular risk score postpartum For this 76 individuals with hypertensive disorders of pregnancy HDP will be randomized to atorvastatin 10mg or placebo which will be started in the postpartum period after cessation of breast feeding and continued for 3 months
Detailed Description:
Individuals will be followed for up to 1 year to address the following specific aims
Specific Aim 1 To determine if among individuals diagnosed with hypertensive disorders of pregnancy HDP the use of atorvastatin 10 mg daily initiated in the postpartum period following cessation of breastfeeding and continued for 3 months lowers cardiovascular risk as measured by the Framingham Risk Score for Cardiovascular Disease 30 year risk primary outcome and cardiovascular risk prediction model PREVENT secondary outcome compared with placebo and if the benefit will persist for at least 3-6 months following discontinuation of atorvastatin treatment
Specific Aim 2 To determine if among individuals diagnosed with HDP the use of atorvastatin 10 mg daily initiated in the postpartum period following cessation of breastfeeding and continued for 3 months lowers the frequency of metabolic syndrome improves lipid levels and reduces inflammatory markers compared with placebo and if this benefit will persist for at least 3-6 months following discontinuation of atorvastatin treatment
Specific Aim 1 To determine if among individuals diagnosed with hypertensive disorders of pregnancy HDP the use of atorvastatin 10 mg daily initiated in the postpartum period following cessation of breastfeeding and continued for 3 months lowers cardiovascular risk as measured by the Framingham Risk Score for Cardiovascular Disease 30 year risk primary outcome and cardiovascular risk prediction model PREVENT secondary outcome compared with placebo and if the benefit will persist for at least 3-6 months following discontinuation of atorvastatin treatment
Specific Aim 2 To determine if among individuals diagnosed with HDP the use of atorvastatin 10 mg daily initiated in the postpartum period following cessation of breastfeeding and continued for 3 months lowers the frequency of metabolic syndrome improves lipid levels and reduces inflammatory markers compared with placebo and if this benefit will persist for at least 3-6 months following discontinuation of atorvastatin treatment
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