Cerebrosinovenous ThrombosisNCT07523347
Efficacy and Safety of Oral Rivaroxaban in Cerebrosinovenous Thrombosis
A study testing Rivaroxaban and Warfarin in people with Cerebrosinovenous Thrombosis, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
The study seeks to fill the gaps regarding safety and efficacy of rivaroxaban and standard anticoagulant. therefore the current study was planned with the aim to determine the safety and efficacy of rivaroxaban and standard anticoagulant in the treatment of cerebrosinovenous thrombosis (CSVT). Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Cerebrosinovenous Thrombosis
- What is being tested?
- Rivaroxaban and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 31 Dec 2025
- Phase
- Interventional
- 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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any gender
- Aged 2 months to 18 years
- Patients presenting with CSVT evident by computed tomography (CT) or magnetic resonance venography (MRV).
Who cannot join
- Patients having active bleeding or having high risk of bleeding
- Estimated glomerular filtration rate < 30 milliliter/minute per 1.73 m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Determine the Safety and Efficacy of Oral Rivaroxaban and Standard Anticoagulant in the Treatment of Cerebrosinovenous Thrombosis in Children
The study seeks to fill the gaps regarding safety and efficacy of rivaroxaban and standard anticoagulant. therefore the current study was planned with the aim to determine the safety and efficacy of rivaroxaban and standard anticoagulant in the treatment of cerebrosinovenous thrombosis (CSVT).
Read the detailed description
There have not been any randomized controlled trials in the country to demonstrate the efficacy, safety and outcome after the oral use of rivaroxaban in pediatric population and establish its protocol with body weight adjusted dosages in children. The findings of this study would not only add to the local data but also be of great interest to physicians and CSVT patients if an anticoagulant were found to have predictable effects and no need for therapeutic INR monitoring.
- Conditions
- Cerebrosinovenous Thrombosis
- Being tested
- Rivaroxaban, Warfarin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Children were treated initially with low molecular weight heparin (LMWH) for 7 to 10 days followed by oral rivaroxaban for 3 months.
WarfarinDrug
Children received initially low molecular weight heparin (LMWH) for 7 to 10 days followed by oral warfarin for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban-Group | Experimental | Children were treated initially with low molecular weight heparin (LMWH) for 7 to 10 days followed by oral rivaroxaban for 3 months. Receives: Drug: Rivaroxaban |
| Warfarin-Group | Experimental | Children received initially low molecular weight heparin (LMWH) for 7 to 10 days followed by oral warfarin for 3 months. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy
Efficacy was considered "yes" if, after recanalization, the veins demonstrated normalization upon venography as compared to baseline.
Measured: 3 months
Secondary outcomes (2)
Bleeding events
The treatment was considered 'safe', if no any bleeding event occurred within the course of treatment.
Measured: 3 months
Prolonged International Normalized Ratio (INR)
The treatment was considered 'safe', if INR did not exceed 3.0.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Dec 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrosinovenous ThrombosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Muhammad Zia-Ur-Rehman, FCPS, Principal investigator, The Children's Hospital, Lahore, PakistanMuhammad Sohail, FCPS, Principal investigator, The Children's Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523347
- Sponsor's protocol ID
- Dr-Zia-ur-Rehaman-LHR
- Status last verified
- Mar 2026
- First submitted
- 4 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Safety and Efficacy of Oral Rivaroxaban and Standard Anticoagulant in the Treatment of Cerebrosinovenous Thrombosis in Children
- ClinicalTrials.gov ID
- NCT07523347
- Acronym / sponsor ID
- Dr-Zia-ur-Rehaman-LHR
- Conditions
- Cerebrosinovenous Thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Apr 2026 (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.
The study seeks to fill the gaps regarding safety and efficacy of rivaroxaban and standard anticoagulant. therefore the current study was planned with the aim to determine the safety and efficacy of rivaroxaban and standard anticoagulant in the treatment of cerebrosinovenous thrombosis (CSVT).
Detailed description
There have not been any randomized controlled trials in the country to demonstrate the efficacy, safety and outcome after the oral use of rivaroxaban in pediatric population and establish its protocol with body weight adjusted dosages in children. The findings of this study would not only add to the local data but also be of great interest to physicians and CSVT patients if an anticoagulant were found to have predictable effects and no need for therapeutic INR monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban-Group | Experimental | Drug: RivaroxabanChildren were treated initially with low molecular weight heparin (LMWH) for 7 to 10 days followed by oral rivaroxaban for 3 months. |
| Warfarin-Group | Experimental | Drug: WarfarinChildren received initially low molecular weight heparin (LMWH) for 7 to 10 days followed by oral warfarin for 3 months. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Any gender
- Aged 2 months to 18 years
- Patients presenting with CSVT evident by computed tomography (CT) or magnetic resonance venography (MRV).
Key exclusion criteria (2 listed)
- Patients having active bleeding or having high risk of bleeding
- Estimated glomerular filtration rate < 30 milliliter/minute per 1.73 m2.
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 |
|---|---|---|
| RivaroxabanChildren were treated initially with low molecular weight heparin (LMWH) for 7 to 10 days followed by oral rivaroxaban for 3 months. | Drug | Rivaroxaban-Group |
| WarfarinChildren received initially low molecular weight heparin (LMWH) for 7 to 10 days followed by oral warfarin for 3 months. | Drug | Warfarin-Group |
Primary outcome
Treatment efficacy
Time frame: 3 months
Efficacy was considered "yes" if, after recanalization, the veins demonstrated normalization upon venography as compared to baseline.
2 secondary outcomes
Bleeding events
Time frame: 3 months
Prolonged International Normalized Ratio (INR)
Time frame: 3 months
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 13 Apr 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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 Zia-Ur-Rehman, FCPS principal investigator
The Children's Hospital, Lahore, Pakistan
Muhammad Sohail, FCPS principal investigator
The 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 study testing Rivaroxaban and Warfarin in people with Cerebrosinovenous Thrombosis, run by Muhammad Aamir Latif 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 3 inclusion and 2 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 13 Apr 2026. 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.
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?
Treatment efficacy (time frame: 3 months). 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 13 Apr 2026.