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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000047

Enrollment

2408

Registered

2009-05-13

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: null- Symptomatic Deep Vein Thrombosis and Pulmonary Embolism

Interventions

Intervention1: Apixaban: Drug: Placebo for enoxaparin solution, subcutaneous, 1 mg/kg Q12h until sham INR &#8805

2, twice daily Drug: Placebo for warfarin tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months Drug: apixaban tablets, oral, 10 mg tablets, twice daily, for 7 day

2, twice daily Drug: warfarin tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months Drug: Placebo for apixaban tablets, oral, 10 mg tablets, twice daily, for 7 days fol

Eligibility

Inclusion criteria

Inclusion criteria: Men and women &#8805; 18 years of age Clinical diagnosis of DVT or PE

Exclusion criteria

Exclusion criteria: Contraindications for enoxaparin or warfarin Active bleeding or high risk for serious bleeding Short life expectancy Uncontrolled high blood pressure Significantly impaired kidney or liver function

Design outcomes

Primary

Measure	Time frame
Venous thromboembolic recurrence or death [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ]Timepoint: 6 months	—

Secondary

Measure	Time frame
Bleeding [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ]Timepoint: 6	—

Countries

India

Contacts

Public ContactDr Manish Mistry

Bristol-Myers Squibb

vinod.mattoo@bms.com022-66288630

Outcome results

None listed

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