Metamizole (Optalgin) impact on anti‑Xa levels in cancer patients on apixaban or rivaroxaban

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional pharmacokinetic interaction study enrolls adult oncology patients who are receiving the DOACs apixaban or rivaroxaban and who start or are taking metamizole (Optalgin) at the specified dose. Participants will have anti‑Xa concentrations measured to detect changes potentially attributable to metamizole exposure. Key eligibility includes platelets ≥100×10⁹/L and ECOG performance status <3, while patients with allergies to the drugs or significant GI disorders affecting absorption are excluded. The single-site study is conducted at Rambam Health Care Campus and focuses on short‑term drug interaction effects rather than clinical outcomes like bleeding or thrombosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* ECOG PS\<3
* Provided informed consent

Exclusion Criteria:

* 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)

Where it's running

• Rambam Health Care Campus
  Haifa, Israel Recruiting

Study contacts

• Study coordinator: Liat Rappaport
• Email: o_trials@rambam.health.gov.il
• Phone: +97247776234

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.