Deep Vein Thrombosis (DVT)Phase 1NCT07077954
COMPARISON OF WARFARIN AND RIVAROXABAN IN THE TREATMENT OF LOWER LIMB DEEP VENOUS THROMBOSIS
A Phase 1 study testing Rivaroxaban and Warfarin in people with Deep Vein Thrombosis (DVT), run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Deep Vein Thrombosis (DVT)
- What is being tested?
- Rivaroxaban and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jan 2023to 20 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF THE EFFECTIVITY OF WARFARIN AND RIVAROXABAN IN THE TREATMENT OF LOWER LIMB DEEP VENOUS THROMBOSIS
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
Read the 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)
- Being tested
- Rivaroxaban, Warfarin
- Keywords
- rivaroxaban, deep vein thrombosis, warfarin
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Rivaroxaban used to treat DVT
WarfarinDrug
warfarin used for DVT
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Rivaroxaban given for DVT Receives: Drug: Rivaroxaban |
| Warfarin | Experimental | Warfarin given for DVT Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recanalization
recanalization of all four segments including common femoral, superficial femoral, deep femoral and popliteal vein
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start20 Jan 2023
- Primary completion19 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis (DVT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children Hospital and Institute of Child Health, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Adeel Ashiq, Children Hospital and Institute of Child Health, Lahore
- Investigators
- Muhammad Adeel Ashiq, MBBS,MS, Principal investigator, Children's Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077954
- Sponsor's protocol ID
- adeel 8
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As it is an intial study we will share after prolonged study
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE EFFECTIVITY OF WARFARIN AND RIVAROXABAN IN THE TREATMENT OF LOWER LIMB DEEP VENOUS THROMBOSIS
- ClinicalTrials.gov ID
- NCT07077954
- Acronym / sponsor ID
- adeel 8
- Conditions
- Deep Vein Thrombosis (DVT)
- Keywords
- rivaroxaban, deep vein thrombosis, warfarin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Children Hospital and Institute of Child Health, LahoreUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: RivaroxabanRivaroxaban given for DVT |
| Warfarin | Experimental | Drug: WarfarinWarfarin given for DVT |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanRivaroxaban used to treat DVT | Drug | Rivaroxaban |
| Warfarinwarfarin used for DVT | Drug | Warfarin |
Primary outcome
Recanalization
Time frame: 12 weeks
recanalization of all four segments including common femoral, superficial femoral, deep femoral and popliteal vein
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No. As it is an intial study we will share after prolonged study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Adeel Ashiq, MBBS,MS principal investigator
Children's Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rivaroxaban and Warfarin in people with Deep Vein Thrombosis (DVT), run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recanalization (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.