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Cardiovascular DiseasesPhase 4PREVESTATGxNCT06262685

Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins

A Phase 4 study testing Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines, Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines and Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines in people with Cardiovascular Diseases and Dyslipidemias, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines, Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines and Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteSpain
Study dates
4 Mar 2024to 4 Mar 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each potential participant must satisfy all of the following criteria to be enrolled in the study:
  • Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
  • Subject has voluntarily signed the ICF.
  • Subject must be ≥ 18 years old at the time of signing ICF.
  • Subject is able and willing to take part and be followed-up for the majority of the study duration.
  • Participants are susceptible to be prescribed any of the following:
Show all 16Show fewer
  • Atorvastatin ≥40 mg/day p.o.
  • Simvastatin ≥20mg/day p.o.
  • Pitavastatin≥2mg/day p.o.
  • Rosuvastatin ≥40mg/day p.o.
  • Pravastatin ≥40mg/day p.o.
  • Lovastatin ≥40mg/day p.o.
  • Fluvastatin ≥80 mg/day p.o.
  • Subjects must be naïve to any genotyping test of the following genes: SCLO1B1, ABCG2, CYP2C9, CYP3A4, CYP3A5 and HMGCR.
  • Subjects must be willing to comply and adhere to any treatment plan modifications established and to the procedures specified in this protocol.
  • Women of childbearing potential must commit not to become pregnant. Subjects must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study.

Who cannot join

  • Any potential participant who meets any of the following criteria will be excluded from participating in the study:
  • Subject is currently taking ubiquinone (Q10) supplements.
  • Known personal or family history of statin-associated autoimmune myopathy or HMG-CoA reductase disorder.
  • Pregnant or breastfeeding women
  • Subject has a personal history or analytical evidence of one of the following disorders:
  • Any contraindications to statin administration as revealed in the summary of product characteristics (SmPCs) for statins.
  • Prior SAMS if subject is not statin-naïve.
  • Any condition or situation deemed by the investigator precluding or interfering with the present study.

Trial locations and contacts

1 site in 1 country.

Alberto M. Borobia Pérez, MD, PhD contact

+34 912071466

alberto.borobia@salud.madrid.org

Spain1 site

  • Hospital La Paz

    Madrid, Madrid, 28046

    Stefan Mark Stewart Balbás, MD

Other trials in Spain

About this study

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 High/Moderate-intensity Statins

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

Read the 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.

Being tested
Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines, Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines, Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines, Preemptive pharmacogenetic rosuvastatin dose based on CPIC guidelines, Preemptive pharmacogenetic pravastatin dose based on CPIC guidelines
Keywords
Statin, Statin Associated Muscle Symptoms, Cardiovascular disease, Cost-effectiveness, Phase IV Clinical Trial, Pharmacogenetic
Medical subject headings
Cardiovascular Diseases, Dyslipidemias, Malignant fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelinesOther

    Atorvastatin at the dosage reccomended by the 2022 "Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms" based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/

  • Preemptive pharmacogenetic simvastatin dose based on CPIC guidelinesOther

    Simvastatin at the dosage reccomended by the 2022 "Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms" based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/

  • Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelinesOther

    Pitavastatin at the dosage reccomended by the 2022 "Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms" based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/

  • Preemptive pharmacogenetic rosuvastatin dose based on CPIC guidelinesOther

    Rosuvastatin at the dosage reccomended by the 2022 "Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms" based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/

  • Preemptive pharmacogenetic pravastatin dose based on CPIC guidelinesOther

    Pravastatin at the dosage reccomended by the 2022 "Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms" based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/

  • Preemptive pharmacogenetic lovastatin dose based on CPIC guidelinesOther

    Lovastatin at the dosage reccomended by the 2022 "Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms" based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/

  • Preemptive pharmacogenetic fluvastatin dose based on CPIC guidelinesOther

    Fluvastatin at the dosage reccomended by the 2022 "Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms" based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/

  • Standard of Care (SoC) dosing of atorvastatinOther

    Subject allocated to this arm will receive the atorvastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype

  • Standard of Care (SoC) dosing of simvastatinOther

    Subject allocated to this arm will receive the simvastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype

  • Standard of Care (SoC) dosing of pitavastatinOther

    Subject allocated to this arm will receive the pitavastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype

  • Standard of Care (SoC) dosing of rosuvastatinOther

    Subject allocated to this arm will receive the rosuvastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype

  • Standard of Care (SoC) dosing of prasavastatinOther

    Subject allocated to this arm will receive the prasavastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype.

  • Standard of Care (SoC) dosing of lovastatinOther

    Subject allocated to this arm will receive the lovastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype.

  • Standard of Care (SoC) dosing of fluvastatinOther

    Subject allocated to this arm will receive the fluvastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype.

Study groups in NCT06262685
Study groupRoleWhat they receive
Experimental GroupExperimentalPatients in this Experimental Group will receive any of the statins authorized in Spain for lipid-lowering, both for primary and secondary prevention. Subjects in the Experimental Group will be administered the specific type and dosage of statins recommended by the Clinical Pharmacogenetics Consortium's genotype guidelines, utilizing the patient's pharmacogenetic information and characteristics
Receives: Other: Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines; Other: Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines; Other: Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines; Other: Preemptive pharmacogenetic rosuvastatin dose based on CPIC guidelines; Other: Preemptive pharmacogenetic pravastatin dose based on CPIC guidelines; Other: Preemptive pharmacogenetic lovastatin dose based on CPIC guidelines; Other: Preemptive pharmacogenetic fluvastatin dose based on CPIC guidelines
Control GroupActive comparatorPatients in this Control Group will receive any of the authorized statins in Spain for lipid-lowering, whether for primary or secondary prevention. They will be administered statins according to clinical practice and the drug's product labeling, without exceeding the already authorized dosages
Receives: Other: Standard of Care (SoC) dosing of atorvastatin; Other: Standard of Care (SoC) dosing of simvastatin; Other: Standard of Care (SoC) dosing of pitavastatin; Other: Standard of Care (SoC) dosing of rosuvastatin; Other: Standard of Care (SoC) dosing of prasavastatin; Other: Standard of Care (SoC) dosing of lovastatin; Other: Standard of Care (SoC) dosing of fluvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of clinically relevant statin-associated musculoskeletal events

    As defined by the a composite endpoint:

    Patients with a clinically relevant statin-associated musculoskeletal symptom defined as a combination of a SAMS-CI (Statin Associated Muscular Symptoms Clinical Index) score ≥7 points and a NPRS (Numerical Pain Rating Scale) score ≥3) in the 9-month follow-up period

    Serum creatin phosphokinase (CPK) [UI/L] greater than three times the upper limit of normality prespecified by each centre's laboratory, in relation to the statin.

    Measured: 9-months

Secondary outcomes (3)

  1. Low density lipoprotein cholesterol (LDLc) serum concentration baseline reduction rate

    Percentage of Baseline LDLc serum concentration reduction rate when compared to LDLc serum concentration values at 9 months.

    Measured: 9-months

  2. Baseline change in statin therapy prescription

    Percentage of patients that require either a statin dose modification/withdrawal or additional lipid-lowering therapy after 9 months in order to meet LDLc goals.

    Measured: 9-months

  3. Cost of a statin preemptive pharmacogenetic prescription scheme

    To quantify economic burden a cost-benefit analysis defined as the difference [in monetary units, euros] between the costs of the intervention [pharmacogenetic analysis] and all its surrounding procedures [personnel, geneticist report, clinical pharmacologist report] combined with the costs derived from the events [blood sample analysis, hospital admission, follow-up visits, lipid-lowering therapy modification] in the intervention arm when compared to the costs derived from the events in the control arm alone

    Monetary units requiered to prevent a event will be calculated through an incremental cost effectiveness ratio (ICER) between intervention and control arm .

    Measured: Though study completion, on average 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2024
  2. Study start4 Mar 2024 (estimated)
  3. Primary completion10 Feb 2025 (estimated)
  4. Study completion4 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase IV, multicentre, controlled, randomized, parallel and single-blind adaptive clinical trial nested within the iPHARMGx master protocol study
Masking
Single blind
Who is masked
Participant
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06262685
Sponsor's protocol ID
2023-509418-12-00
Other IDs
2023
Acronym
PREVESTATGx
Status last verified
Jan 2024
First submitted
9 Jan 2024
Last updated
16 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A copy of the database of data collected during the clinical trial will be attached as an appendix to the publication resulting from this clinical trial.

Publications

  • Stewart S, Seco-Meseguer E, Diago-Sempere E, Marin-Candon A, Carmona M, Estebanez M, Lopez-Fernandez LA, Imaz-Iglesia I, Del Mar Garcia Saiz M, Laserna-Mendieta EJ, Peiro AM, Farre M, Rodriguez-Jimenez C, Saiz-Rodriguez M, Sanabria-Cabrera J, Rosas-Alonso R, Abad-Santos F, Pedrosa L, Carcas AJ, Garcia Garcia I, Borobia AM; iPHARMGx study group. Phase IV adaptive randomised clinical trials evaluating efficacy and cost-efficacy of pre-emptive pharmacogenetic genotyping strategies in the Spanish National Health System: iPHARMGx Master Protocol and PREVESTATGx nested clinical trial. BMJ Open. 2024 Nov 7;14(11):e089823. doi: 10.1136/bmjopen-2024-089823.

    PubMed 39510769

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines, Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines and Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines in people with Cardiovascular Diseases and Dyslipidemias, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alberto M. Borobia Pérez, MD, PhD (+34 912071466, alberto.borobia@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of clinically relevant statin-associated musculoskeletal events (time frame: 9-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06262685, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.

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