Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262685
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-01-09
Brief Title:
Efficacy Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins
Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Organization:
Instituto de Investigación Hospital Universitario La Paz
Study Overview
Official Title:
A Multicenter Controlled Randomized Single-blind Phase IV Trial Assesses Efficacy Safety and Cost of Pre-emptive Genotyping in a Cardiovascular Risk Population Eligible for HighModerate-intensity Statins
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
PREVESTATGx
Brief Summary:
This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is efficacious cost-efficacious and feasible within the Spanish National Health System when compared to the current standard of care This trial is nested within the iPHARMGx master protocol
Detailed Description:
This is a nation-wide multicentre randomised controlled and adaptive phase IV clinical trial that aims to assess the efficacy and cost-efficacy of pre-emptive pharmacogenetic testing strategies including those impacted by genetic variants associated with adverse drug reactions ADRs or limited efficacy Populations at high-risk of developing clinically relevant outcomes will be enrolled in nested trials within this master protocol The clinical trials will evaluate the efficacy and cost-efficacy of pre-emptive genotyping by defining a drug-gene-endpoint triad Study subjects will be pre-emptively genotyped and if found to have an actionable gene variant randomly allocated to either a test group where guideline-based treatment modifications will be initiated or a control group that will be managed according to healthcare provider standard of care SoC Subsequently subjects will be prospectively followed at prespecified timepoints Detailed information on drug-gene-endpoint triads allocation schemes and follow-up visits will be provided in each of the subprotocols A Data Monitoring Committee DMC composed of physician experts will be appointed for each nested trial to review the data on an ongoing basis ensuring the safety of participants and scientific validity of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None