Predicting adverse reactions to cardiovascular drugs using genetics
Pharmacogenomics in Prediction of Cardiovascular Drugs Adverse Reaction
This study is trying to see if people's genetics can help predict bad reactions to certain heart medications in about 1,200 patients starting treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinical Hospital Centre Zagreb Academic / other |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT05307718 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit approximately 1,200 participants who are starting treatment with specific cardiovascular drugs, including novel oral anticoagulants, platelet aggregation inhibitors, and statins. It will analyze adverse drug reactions (ADRs) based on various factors such as age, gender, and severity, while also considering genetic profiles. The study will involve collecting blood samples for pharmacogenetic analysis to better understand how individual genetic variations may influence drug responses and side effects. The research is designed to improve the safety and efficacy of cardiovascular pharmacotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are starting treatment with the specified cardiovascular medications.
Not a fit: Patients with contraindications to the medications of interest will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and safer cardiovascular drug therapies for patients.
How similar studies have performed: Other studies have shown promise in using pharmacogenetics to predict drug responses, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: a) age 18 years or older; b) a new indication for the administration of any of the medicinal products of primary interest (NOAC, clopidogrel, prasugrel, ticagrelor, statins) for which at least a 3-month administration is predicted; c) signed informed consent (for repeated evaluations and donation of blood samples for genetic and eventual pharmacokinetic analysis). Exclusion Criteria: the existence of contraindications to the medicines of primary interest.
Where this trial is running
Zagreb
- UHC Zagreb — Zagreb, Croatia (Recruiting)
Study contacts
- Principal investigator: Tamara Bozina, PhD — University of Zagreb, Schooll of Medicine
- Study coordinator: Tamara Bozina, PhD
- Email: tamara.bozina@mef.hr
- Phone: +385 1 45 66 777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.