CompletedPhase 1

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

Pakistan74 participantsStarted 2023-01-20

Plain-language 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

Who can participate

Age range16 Years – 70 Years

SexALL

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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. Exclusion Criteria: * Exclusion Criteria: Patients taking other medications that can interact with warfarin or Rivaroxaban including aspirin, ibuprofen, clarithromycin, antihistamines, and SSRIs.Patients with co-morbid conditions that can affect coagulation, including CLD and CKD (CrCl\<30), documented in previous hospital records. Pregnant and lactating females were excluded.

What they're measuring

Recanalization

Timeframe: 12 weeks

Trial details

NCT IDNCT07077954

SponsorChildren Hospital and Institute of Child Health, Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-19