Pragmatic clinical trial to assess the utility of SLCO1B1, ABCG2, and CYP2C9 preemtive genotyping and pharmacogenetics training on the incidence of musculoskeletal adverse reactions in patients treated with statins in primary and specialized care.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11], Diseases [C] - Cardiovascular Diseases [C14], Phenomena and Processes [G] - Genetic Phenomena [G05]

Trial duration

25 Jun 2024 → ongoing

Decision date (initial)

2024-02-19

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fundación para la Investigación Biomédica del Hospital Universitario de La Princesa.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacogenetic

The main objective is to evaluate the differences in the outcomes of musculoskeletal adverse reactions in a group of patients treated with statines according to clinical practice (control group) vs patients with a prescribed statin based on the prosprective genotyping of SLCO1B1, ABCG2 and CYP2C9 (intervention group), in a follow-up period of 6 months in patients treated from primary attention (healthcare centers) and hospitals ( Hospital de La Princesa).

Secondary objectives 1

1. 1.Evaluate the differences on the incidence of musculoskeletal adverse reactions between intervention and control group on the follow-up period of 6 months. 2. Evaluate the differences in the efficacy of statins (for example in the reduction of LDL levels) between intervention and control group. 3. Evaluate the differences on cardiac events, death and other musculoskeletal adverse reactions (RAME) between intervention and control group. 4. Evaluate the prescriptor´s profesional training about the incidence of RAME in a follow-up period of 6 months and more; of the efficacy of statins; of cardiac events incidence, death and other adverse reactions between intervention and control group. 5. Evaluate the awareness of doctors from primary and hospital attention regarding to the use of pharmacogenetics biomarkers and the needs of training as a working tool of prescription. 6. Evaluate the cost-opportunity of the prospective genotype of SLCO1B1, ABCG2 and CYP2C9 in the prevention of RAME in patientes treated with statins. 7. Explore the impact of other genetic variables, clinical and demographic variables about efficacy and safety of statins. 8. Explore the relation between RAME-pharmacogenetics markables in all patients of the study (both groups). 9. Explore other genetics variables in relation on other drugs.

Conditions and MedDRA coding

Cardiovascular risk which needs primary or secundary prevention with statins

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Adults, with any type of cardiovascular risk (high, moderate or low): a) In which it is indicated statins as a treatment at any dose. b) Pacients who must be outpatients, recruited in a health care centre (primary attention) or in hospitals (primary or secundary prevention). c) Pacients who must have never taken statins or who have started statin treatment less tan 15 days ago, or who had their statin dose increased or changed to a more potent statin due to bad control of LDL levels in the last 15 days. d) Patients who have to give their inform consent form written

Exclusion criteria 1

1. a) Pacients who statins are not prescribed as standard clinical practice. b) Pacients who suffer a malignant or terminal disease whose live expectancy will be less than 6 months. c) Pacients who have statins contraindicated for treatment d) Pregnant or breast-feeding patients.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The incidence of musculoskeletal adverse reactions induced during the first 6 months of treatment (measurement at 6 months).

Secondary endpoints 1

1. The incidence of musculoskeletal adverse reactions at 12 months or longer follow up.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

Sponsor organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

Address

Calle De Diego De Leon 62

City

Madrid

Postcode

28006

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

Contact name

Francisco Abad Santos

Public contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

Contact name

Francisco Abad Santos

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications