Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 month Treatment for Acute symptomatic venous thromboembolism (VTE).

A phase III randomised, double blind, parallel-group study of the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism, following initial treatment for at least 5 days with a parenteral anticoagulant approved for this indication. Acronym RE-COVER II

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000686

Enrollment

2554

Registered

2009-09-24

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- Acute symptomatic venous thromboembolism.

Interventions

Intervention1: Dabigatran etexilate: 150 mg bid for 6 months, Orally Control Intervention1: warfarin: PRN to maintain an INR of 2.0-3.0 for 6 months, Orally

Eligibility

Inclusion criteria

Inclusion criteria: Acute symptomatic uni- or bilateral DVT of the leg involving proximal veins, and/or PE Male or female, being 18 years of age or older Written informed consent for study participation

Exclusion criteria

Exclusion criteria: Persistent symptoms of VTE PE requiring urgent intervention Use of vena cava filter Contraindications to anticoagulant therapy Allergy to study medications Elevated AST or ALT > 3x ULN or known liver disease expected to have an impact on survival Severe renal impairment Patients considered unsuitable for inclusion

Design outcomes

Primary

Measure	Time frame
A composite of recurrent symptomatic VTE and deaths related to VTE within 6 months (VTE is defined as the composite incidence of DVT of the leg (including the inferior caval vein) and PE).Timepoint: Time Frame: 6 months	—

Secondary

Measure	Time frame
Efficacy: Composite of recurrent symptomatic VTE and all deaths, Symptomatic DVT, Symptomatic PE, Deaths related to VTE, All deaths Safety: Incidence of Bleeding Events, AE, Discontinuation due to AE, Laboratory measures, ACS, vital signs.Timepoint: Time Frame: 6 months	—

Countries

India, Thailand

Contacts

Public ContactSuneela Thatte

Quintiles Research India Pvt Ltd

sanghamitra.patnaik@quintiles.com07966303340

Outcome results

None listed

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

Phase III Study Testing Efficacy &amp; Safety of Oral Dabigatran Etexilate vs Warfarin for 6 month Treatment for Acute symptomatic venous thromboembolism (VTE).