BridgeMD
A clinical trial to evaluate efficacy, safety and cost-efficacy of gene analysis strategy in a population at risk of cardiovascular disease susceptible of receiving high or moderate-intensity doses of statins
EU CTIS ID: 2023-509418-12-00
What this study is testing
To assess the efficacy of a statin preemptive genotyping strategy in reducing statin associated musculoskeletal adverse events.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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: a. Atorvastatin ≥40 mg/day p.o. b. Simvastatin ≥20mg/day p.o. c. Pitavastatin≥2mg/day p.o. d. Rosuvastatin ≥40mg/day p.o. e. Pravastatin ≥40mg/day p.o. f. Lovastatin ≥40mg/day p.o. g. 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.
You likely can't join if
- 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: a. Any contraindications to statin administration as revealed in the summary of product characteristics (SmPCs) for statins. b. Prior SAMS if subject is not statin-naïve.
- Any condition or situation deemed by the investigator precluding or interfering with the present study.
See the full eligibility criteria
- 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: a. Atorvastatin ≥40 mg/day p.o. b. Simvastatin ≥20mg/day p.o. c. Pitavastatin≥2mg/day p.o. d. Rosuvastatin ≥40mg/day p.o. e. Pravastatin ≥40mg/day p.o. f. Lovastatin ≥40mg/day p.o. g. 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.
- 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: a. Any contraindications to statin administration as revealed in the summary of product characteristics (SmPCs) for statins. b. Prior SAMS if subject is not statin-naïve.
- Any condition or situation deemed by the investigator precluding or interfering with the present study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.