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Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism

A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000050
Enrollment
Unknown
Registered
2009-05-28
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

None listed

Interventions

Intervention1: Apixaban 2.5 mg: Drug: Apixaban Tablets, Oral, twice daily, 12 months Intervention2: Apixaban 5mg: Drug: Apixaban Tablets, Oral, twice daily, 12 months Control Intervention1: Placebo:

Sponsors

This trial is being sponsored by BristolMyers Squibb
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Men and women ≥ 18 years of age; Clinical diagnosis of DVT or PE; Anticoagulant treatment completed No recurrence of VTE

Exclusion criteria

Exclusion criteria: Subjects with indications for long-term treatment with a vitamin K antagonist Active bleeding or high risk for serious bleeding Short life expectancy Uncontrolled high blood pressure Impaired kidney or liver function

Design outcomes

Primary

MeasureTime frame
Venous Thromboembolic Recurrence or Death [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ] Timepoint:—

Secondary

MeasureTime frame
Bleeding [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ] Timepoint:—

Countries

India

Contacts

Public ContactDr Vinod Mattoo

Bristol-Myers Squibb

vinod.mattoo@bms.com02266288630

Outcome results

None listed

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