Skip to content

Apixaban tablet versus Enoxaparin for prevention of venous thromboembolism in women undergoing surgery for gynecological cancers

A randomized controlled trial of oral Apixaban compared to parenteral Enoxaparin for prevention of venous thromboembolism in patients undergoing gynecologic cancer surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020134
Enrollment
500
Registered
2019-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: Z790- Long term (current) use of anticoagulants and antithrombotics/antiplatelets

Interventions

Intervention1: Apixaban 2.5 mg PO: Post-discharge apixaban 2.5 mg BID PO in patients undergoing planned surgery for gynaecological cancer and have received antithrombotic prophylaxis with LMWH during

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Objective diagnosis of gynaecological malignancy 2) Planned major surgery for gynaecological malignancies 3) Antithrombotic prophylaxis with LMWH administered for 7 ± 2 days after surgery

Exclusion criteria

Exclusion criteria: 1) Age 2) Surgery for non-cancer disease 3) Duration of surgery 4) Pre-existing DVT/PE 5) Other indication for anticoagulant therapy 6) Known cerebral metastases 7) Kidney or liver failure (creatinine clearance 8) Known haemorrhagic diathesis or high risk for bleeding 9) History of intracerebral bleeding or neurosurgery within 6 months 10) History of heparin induced thrombocytopenia 11) Pregnancy or lactation 12) Refusal of informed consent

Design outcomes

Primary

MeasureTime frame
Composite of symptomatic objectively confirmed DVT/VTE, asymptomatic ultrasonography-confirmed DVT; DVT/VTE-related death within 30 days from surgery for gynaecological cancerTimepoint: 30 days

Secondary

MeasureTime frame
Major bleedingTimepoint: Entire study period

Countries

India

Contacts

Public ContactDr Abraham Peedicayil

Christian Medical College

drmona.n@gmail.com0416-2283393

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026