Study Protocol: Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs

Rambam Health Care Campus

Status: Enrolling

Conditions: Coagulation Defect; Pain Management; Oncologic Diseases

Treatments: Drug: metamizole

Study type: Interventional

Funder types: Other

Identifiers

NCT07384013

0268-25-RMB

Details and patient eligibility

About

Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)

Full description

Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Cohort 1: Chronic metamizole users

Experimental group

Description:

Patients receiving Optalgin prior to study enrollment

Treatment:

Drug: metamizole

Drug: metamizole

Cohort 2: New metamizole users

Experimental group

Description:

Patients receiving Optalgin after to study enrollment

Treatment:

Drug: metamizole

Drug: metamizole