- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05307718
Pharmacogenomics in Prediction of Cardiovascular Drugs Adverse Reaction
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Tamara Bozina, PhD
- Phone Number: +385 1 45 66 777
- Email: tamara.bozina@mef.hr
Study Contact Backup
- Name: Livija Šimičević, PhD
- Phone Number: +385 1 2388 888
- Email: lsimicev@kbc-zagreb.hr
Study Locations
-
-
-
Zagreb, Croatia, 10000
- Recruiting
- UHC Zagreb
-
Contact:
- Livija Šimičević, PhD
- Phone Number: +385 1 2388 888
- Email: lsimicev@kbc-zagreb.hr
-
Contact:
- Tamara Bozina, PhD
- Phone Number: +385 1 4566 777
- Email: tamara.bozina@mef.hr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
Newly indicated indication for use: DOAC; 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.
Subjects will be followed up during regular visits.
Other Names:
|
Cases
Cases will be subjects who have observed ADRs during follow-up: bleeding that meets the criteria of "major" or "non-major, clinically relevant bleeding (for anticoagulants and platelet aggregation inhibitors); muscle or liver lesions (for statins); any other serious ADR.
|
Newly indicated indication for use: DOAC; 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.
Subjects will be followed up during regular visits.
Other Names:
|
Controls
Controls will be subjects in whom no ADRs were observed during the study
|
Newly indicated indication for use: DOAC; 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.
Subjects will be followed up during regular visits.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The overall project objective is to determine which pharmacogenes variants, together with clinical parameters, can be used as predictors of CV drug ADRs
Time Frame: 4.5 years
|
4.5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tamara Bozina, PhD, University of Zagreb, Schooll of Medicine
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Drug-Related Side Effects and Adverse Reactions
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Antimetabolites
- Protease Inhibitors
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Purinergic P2Y Receptor Antagonists
- Platelet Aggregation Inhibitors
- Factor Xa Inhibitors
Other Study ID Numbers
- UIP-2020-02-8189
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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