Study Protocol: Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRambam Health Care Campus
About this trial
Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult oncology patients (≥18 years old).
Receiving apixaban or rivaroxaban for anticoagulation.
New/current metamizole users taking at least 1g TID for pain management.
Platelets ≥100×10⁹/L
Disqualifiers
History of allergic reaction to metamizole or DOACs.
Individuals with significant gastrointestinal disorders that may affect absorption, including (but not limited to) diagnosed bowel obstruction, persistent diarrhea, or the presence of a nasogastric tube (NGT/zonda)
Trial design
Design model
Parallel
Treatments tested in this trial
metamizole
Drugchronic metamizole use
metamizole
DrugNew metamizole users
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: Chronic metamizole usersExperimental treatment 1 intervention
Group B: Cohort 2: New metamizole usersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in DOAC
Change in DOAC peak and trough concentrations during periods with and without metamizole comedication (5 different time points).
Time frame
1- Baseline 2- End Of Treatment 3- Day 3 Post treatment 4- Day 5 Post Treatment 5- Day 7 Post treatmentSponsors and contacts
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Source ClinicalTrials.gov