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Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2007/091/000024
Enrollment
Unknown
Registered
2008-09-22
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- deep-vein thrombosis or pulmonary embolism

Interventions

Intervention1: Rivaroxaban (BAY59-7939): During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroaxaban 20 mg once-daily. Rivaroxaban will
oral (VKA)

Sponsors

Bayer Healthcare AG
Lead Sponsor
Johnson Johnson Pharmaceutical Research Development LLC
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: - Confirmed acute symptomatic proximal DVT without symptomatic PE OR Confirmed acute symptomatic PE with or without symptomatic DVT

Exclusion criteria

Exclusion criteria: Legal lower age limitations (country specific) - Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE - Other indication for VKA than DVT and/or PE

Design outcomes

Primary

MeasureTime frame
Symptomatic recurrent VTE, occuring during the 3-, 6-, and 12-month study treatment periodsTimepoint: Time Frame: 3-, 6-, or 12-month study treatment period—

Secondary

MeasureTime frame
All deaths and other vascular eventsTimepoint: Time Frame: 3-, 6-, or 12-month study treatment period;Clinically relevant bleeding (i.e., major bleeding and clinically relevant non-major bleeding)Timepoint: Time Frame: 3-, 6-, or 12-month study treatment period—

Countries

India

Contacts

Public ContactDr Ashish Gawde
ashish.gawde@bayer.com02225311201

Outcome results

None listed

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