COMPARISON OF WARFARIN AND RIVAROXABAN IN THE TREATMENT OF LOWER LIMB DEEP VENOUS THROMBOSIS

NCT07077954 | Completed Phase 1 DMC

• 1 other identifier: adeel 8
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This was a randomized controlled trial conducted at General Surgical wards of Mayo Hospital, Lahore.Total 74(37 in each group) patients were included.After heparinizing patients for 48 hours (80 units/kg/stat and 18 units/kg/hour), patients in group-A were started Warfarin (5mg PO/OD), and patients in group-B received Rivaroxaban (15 mg PO/BD) for 21 days and then 20 mg PO/OD for 6 months. The dose of Warfarin was titrated according to INR (monitored on alternate days). Patients were discharged when limb girth was normal, as compared to opposite limb and pain was calmed. Length of stay was noted on day of discharge. Patient were followed on 6th and 12thweeks with doppler USGto assess the recanalization of all four segments including common femoral, superficial femoral, deep femoral and popliteal vein, percentage of recanalized segments was calculated out of total segments

Conditions

Deep Vein Thrombosis (DVT)

Keywords

rivaroxaban; deep vein thrombosis; warfarin

Outcome Measures

Primary Outcomes (1)

• Recanalization

  recanalization of all four segments including common femoral, superficial femoral, deep femoral and popliteal vein

  12 weeks

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

Rivaroxaban given for DVT

Drug: Rivaroxaban

Warfarin

EXPERIMENTAL

Warfarin given for DVT

Drug: Warfarin

Interventions

Rivaroxaban DRUG

Rivaroxaban used to treat DVT

Rivaroxaban

Warfarin DRUG

warfarin used for DVT

Warfarin

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of all genders aged between 16-70years presenting with clinical features (pain and swelling) of lower limb DVT, evidenced by USG Doppler. Thrombosis present in common femoral, superficial femoral, deep femoral and popliteal veins in one lower limb were included.

Sponsors & Collaborators

• Children Hospital and Institute of Child Health, Lahore: lead

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Muhammad Adeel Ashiq, MBBS,MS

  Children's Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 22, 2025
• Study Start: January 20, 2023
• Primary Completion: June 19, 2023
• Study Completion: June 20, 2023
• Last Updated: July 22, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)