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

NCT ID: NCT07077954

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2023-06-20

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

Detailed Description

After approval from IRB, 74 patients meeting selection criteria were carefully chosen from all general surgical wards of Mayo Hospital. Informed written consent form was taken from all patients. Patients were randomized using lottery method and divided into two groups, A and B. History and clinical examination findings were noted. All baselines including INR was noted. USG Doppler findings documenting presence of thrombus in vein segments from common femoral to popliteal vein was noted. After heparinizing patients for 48 hours (80 units/kg stat and 18 units/kg per hour), patients in group A werestarted Warfarin (5mg PO OD), and patients in group B were given 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). While admitted in ward, monitoring was done for clinical improvement, including limb girth and pain severity.

Pain was assessed on scale of zero to 10, where 10 is most severe pain that patient ever had and zero is no pain at all. Limb girth was measured at mid-thigh, between greater trochanter and tibial tuberosity and compared to opposite limb and difference in limb girth was noted. 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 was kept on 6 weekly follow up till 12 weeks. Doppler USG was performed at 6 and 12 weeks to 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 at 6 and 12 weeks. Those patients, who were be able to come in person, were followed through telemedicine. All this data was recorded in proforma. After collection of data; length of stay and percentage of segments recanalized at 6 and 12 weeks were compared between groups.

Data Analysis Procedure Data was entered in SPSS v26.0. Quantitative variables including age and LOS was presented as Mean±SD. Qualitative variables including gender, vessel recanalization, was presented as frequency and percentages. Chi square test was applied to compare Recanalized segments between groups at 6th and 12th week post treatment respectively. Independent t-test was applied and p-value less than 0.05 was taken significant.

Conditions

Deep Vein Thrombosis (DVT)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rivaroxaban

Rivaroxaban given for DVT

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

Rivaroxaban used to treat DVT

Warfarin

Warfarin given for DVT

Group Type: EXPERIMENTAL

Warfarin

Intervention Type: DRUG

warfarin used for DVT

Interventions

Rivaroxaban

Rivaroxaban used to treat DVT

Intervention Type: DRUG

Warfarin

warfarin used for DVT

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children Hospital and Institute of Child Health, Lahore

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Adeel Ashiq

Senior Registrar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Adeel Ashiq, MBBS,MS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital, Lahore

Locations

King Edward Medical University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

adeel 8

Identifier Type: -

Identifier Source: org_study_id