Other Clinical Trial - Pharmacogenomics in Prediction of Cardiovascular

Status Recruiting

Clinical Trial Summary

The research is planned as a prospective nested case-control study. The plan is to recruit about 1,200 consecutive subjects whose pharmacotherapy involves the drug(s) of interest within 4.5 years. The basic cohort - the subjects with the newly indicated indication for use: NOAC; platelet aggregation inhibitors from the P2Y12 receptor antagonist group; and HMG-CoA reductase inhibitors (statins); as monotherapy or without restriction with respect to any other concomitant pharmacotherapy. The ADRs will be analysed by CR by: age, gender, expectancy, severity, association, type (mechanism of event), and outcome, according to the classification of organ systems as well as association with the phenotype. Criteria for bleeding associated with the use of anticoagulant and antiplatelet therapy have been defined; as well as the myotoxicity and hepatotoxicity associated with statin therapy. Samples will be tested for biochemical, haematological, coagulation standard parameters and pharmacogenetic analyses of relevant genes depending on the used therapy. Pharmacogenetic analysis will be performed to genotype the polymorphisms of relevant pharmacogenes: Biological samples and clinical data will be anonymized plus all records of ADRs and other clinical variables will be protected. Possible drug-drug and drug-drug-gene interactions will be evaluated using the Clinical Decision Support System (CDSS) of Lexicomp, PharmGKB, the Flockhart Table, and other systems including panel consensus methods to determine the likelihood of an ADR being associated with drug interactions, and determine whether drug interactions contributed to the occurrence of ADRs to administered CV pharmacotherapy in subjects with variant pharmacogenes of interest (drug-drug-gene interaction). The overall project objective is to determine which pharmacogenes variants, together with clinical parameters, can be used as predictors of CV drug ADRs and are good candidates for inclusion in the clinical diagnostic panel for pre-emptive PGx testing.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Drug-Related Side Effects and Adverse Reactions
Pharmacogenetics

Clinical Trial Details

NCT number	NCT05307718
Study type	Observational
Source	Clinical Hospital Centre Zagreb
Contact	Tamara Bozina, PhD
Phone	+385 1 45 66 777
Email	tamara.bozina@mef.hr
Status	Recruiting
Phase
Start date	December 15, 2020
Completion date	December 14, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03258151` - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Recruiting	`NCT05202964` - Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)
Completed	`NCT04597593` - Association Between Genetic Variant Scores and DOACs (DARES2)
Recruiting	`NCT05096338` - Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Prostate Cancer
Recruiting	`NCT05078190` - Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Breast Cancer
Completed	`NCT02457039` - Acupuncture Prevents Chemobrain in Breast Cancer Patients	N/A
Completed	`NCT02779530` - CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs	Phase 4
Recruiting	`NCT03051880` - Preventive Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors	N/A
Recruiting	`NCT03047863` - Therapeutic Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors	N/A
Completed	`NCT02482025` - The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial	N/A
Not yet recruiting	`NCT03147157` - The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation	N/A
Recruiting	`NCT03156348` - Impact of Clinical Pharmacist on Adverse Drug Events in Older Adults	N/A
Recruiting	`NCT03501108` - Discontinuation of Long-term Medications in Older People Entering Nursing Home Care	N/A
Recruiting	`NCT06427317` - Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment
Completed	`NCT03227653` - Neuropsychiatric Side Effects of Efavirenz in Children Living With HIV
Completed	`NCT03177174` - Different Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma	N/A
Recruiting	`NCT04077281` - Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly In Transitions	N/A
Not yet recruiting	`NCT05247814` - Individual Risk Profiles for Adverse Drug Reactions in Geriatric Patients
Recruiting	`NCT03938597` - Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers
Recruiting	`NCT06291688` - Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pharmacogenomics in Prediction of Cardiovascular Drugs Adverse Reaction

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms