The effectiveness of atorvastatin for deep vein thrombosis prevention in cancer patients undergoing chemotherapy

Comparing the effectiveness between the use of atorvastatin and rivaroxaban for deep vein thrombosis prophylaxis, inflammatory responses, and coagulation activities in cancer patients who have a high risk of thrombosis while undergoing chemotherapy: focus on IL-6, CRP, TF, F1+2, D-dimer, NF-kB, and TNF-alpha serum level and Doppler ultrasonography

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71891829

Enrollment

Registered

2020-12-17

Start date

2021-01-04

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of deep vein thrombosis in cancer patients who have high risk of thrombosis while undergoing chemotherapy Circulatory System

Interventions

Participants who meet the inclusion criteria will be randomized with simple randomization into the study group (atorvastatin 20 mg daily orally) or the control group (rivaroxaban 10 mg daily orally) f

IL-6, CRP, TF, F1+2, D-dimer, NF-kB and TNF-alpha serum levels are measured and re-measured after 3 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Cancer patient with a definite diagnosis of cancer based on anatomy pathological examination 2. Cancer patients who have not received any chemotherapy 3. Khorana risk score =2 4. Age 18-60 years old 5. Has signed the participant agreement

Exclusion criteria

Exclusion criteria: 1. Deep vein thrombosis diagnosed with Doppler ultrasonography examination at baseline 2. Within 14 days post-surgery 3. Pregnancy 4. Taking an anti-thrombotic drug 5. Congenital altered coagulation system 6. Creatinine clearance 3x upper normal limit 8. Patients with total bilirubin total >5 mg/dl 9. Patients with CK >3 x upper normal limit 10. Performance status ECOC =3 11. Patients with cardio-cerebrovascular disease 12. Patients with infection 13. Patients with active, major, serious, life-threatening bleeding that can not be overcome with medical or surgical intervention, esp in a critical area (intra-cranial, pericardial, retroperitoneal, intra-occular, intra-artikular, intraspinal) 14. Malignant hypertension 15. Congenital coagulopathy or severe platelet dysfunction 16. Severe and persistent thrombocytopenia (<20,000/µl)

Design outcomes

Primary

Measure	Time frame
Deep vein thrombosis event measured using Doppler ultrasonography at baseline and 3 months	—

Secondary

Measure	Time frame
1. IL-6 is measured using ELISA at baseline and 3 months 2. NF-kB is measured using ELISA at baseline and 3 months 3. CRP is measured using a spectrophotometer at baseline and 3 months 4. TF is measured using ELISA at baseline and 3 months 5. F1+2 is measured using ELISA at baseline and 3 months 6. D-dimer is measured using ELISA at baseline and 3 months 7. TNF-alpha is measured using ELISA at baseline and 3 months 8. Cost effectiveness is measured using the total cost for each subject	—

Measure

Time frame

1. IL-6 is measured using ELISA at baseline and 3 months 2. NF-kB is measured using ELISA at baseline and 3 months 3. CRP is measured using a spectrophotometer at baseline and 3 months 4. TF is measured using ELISA at baseline and 3 months 5. F1+2 is measured using ELISA at baseline and 3 months 6. D-dimer is measured using ELISA at baseline and 3 months 7. TNF-alpha is measured using ELISA at baseline and 3 months 8. Cost effectiveness is measured using the total cost for each subject

—

Countries

Indonesia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026