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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2007/091/000024
• Date of registration: 22-09-2008
• Prospective Registration: No
• Primary sponsor: Bayer Healthcare AG
• Public title: Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
• Scientific title: Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.
• Date of first enrolment: 22-03-2007
• Target sample size: 0
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=22
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr Ashish Gawde

• Name: Dr Ashish Gawde

Key inclusion & exclusion 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: 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






Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- deep-vein thrombosis or pulmonary embolism

Intervention(s)

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 be administered orally and should be taken with food.
Control Intervention1: Enoxaparin followed by VKE: Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 hr before randomization if enoxaparin twice-daily was used. VKE should be started as soon as possible but not later than 48 hours after randomization
Route of
administration: Subcutaneous (enoxaparin); oral (VKA)

Primary Outcome(s)

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 Outcome(s)

Clinically relevant bleeding (i.e., major bleeding and clinically relevant non-major bleeding)Timepoint: Time Frame: 3-, 6-, or 12-month study treatment period

All deaths and other vascular eventsTimepoint: Time Frame: 3-, 6-, or 12-month study treatment period

Secondary ID(s)

NCT00440193

NCT00439777

2006-004495-13

Source(s) of Monetary Support

Bayer Healthcare AG

Secondary Sponsor(s)

Johnson Johnson Pharmaceutical Research Development LLC

Ethics review

Status: Approved
Approval date: 19/07/2007
Contact:

ethicsCommitteSirGangaramHospitals

Status: Approved
Approval date: 31/07/2007
Contact:

ethics Committe. Poona Medical Research Foundation

Status: Approved
Approval date: 15/10/2007
Contact:

Institutional ethics Committe, Amrita Institute of medical Science

Status: Approved
Approval date: 11/02/2008
Contact:

The Clinical Research & Ethics Committee, PD Hinduja National Hospital and Research Center

Status: Approved
Approval date: 23/02/2008
Contact:

Institutional Reveiw Board, Christian Medical College, Vellore

Status: Approved
Approval date: 26/04/2008
Contact:

Institutional ethics Committe, Nizam Institute of Medical Sciences