Cerebral Venous ThrombosisPhase 1/2NCT03747081
Efficacy Comparison of Warfarin Versus Rivaroxaban CVT
A Phase 1/2 study testing Rivaroxaban and Warfarin in people with Cerebral Venous Thrombosis, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
With regard to Cerebral Venous Thrombosis (CVT) importance as a life threatening disease, specific care is necessary, Known anti-coagulants have limitations.Vitamin K antagonists such as Warfarin, require laboratory monitoring and exact administration starting and maintenance dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Venous Thrombosis
- What is being tested?
- Rivaroxaban and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 1 Sep 2018to 1 May 2020
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients suffering from renal failure(GFR<30) Patients
- Patients with contraindications for oral anticoagulation
- Patient who having pregnancy
- Uncooperative patient for completing the course of treatment
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Alzahra University Hospital
Isfahan, 8174673461
Mohammad Saadatnia, Prof, 9131147179 ext. 98, mosaadatnia@yahoo.com
About this study
Official title: Comparing Treatment Outcomes in CVT Patients Who Treated With Warfarin and Rivaroxaban in Isfahan, Iran
With regard to Cerebral Venous Thrombosis (CVT) importance as a life threatening disease, specific care is necessary, Known anti-coagulants have limitations.Vitamin K antagonists such as Warfarin, require laboratory monitoring and exact administration starting and maintenance dose. although Rivaroxaban(selective and direct Xa factor antagonist ) has no monitoring and no drug interaction. This study aim to focus on efficacy of Warfarin versus Rivaroxaban.
- Conditions
- Cerebral Venous Thrombosis
- Being tested
- Rivaroxaban, Warfarin
- Medical subject headings
- Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Xarelto
Rivaroxaban will administrate to patient with CVT. In first day, enoxaparin is injected to patients and the next day, patients will receive Rivaroxaban and enoxaparin discontinue. Then, patients receive Rivaroxaban for 3 months daily.
WarfarinDrug
Also called Coumadin
Warfarin as a antocoagolant drug will administrate to patient with CVT. In first day, Warfarin plus enoxaparin until adjusting INR index to 2-3. Then, patients receive warfarin for 3 months daily.
| Study group | Role | What they receive |
|---|---|---|
| Rivoroxaban | Experimental | Patients would be administered Enoxaparine (60 mg/SC/BID)in first day, after dicontinuing Enoxaparin in second day, Rivoroxaban 20 mg per day will use. .it would be given once a day.The total duration of Rivoroxaban would be 3 months. Receives: Drug: Rivaroxaban |
| warfarin | Active comparator | Patients would be administered Warfarin with overlap of Enoxaparine utill INR adjust to 2-3 then enoxaparine will disconstinue.it would be given once a day.The total duration of Warfarin would be 3 months Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
based on disability grade(0-6). 0 indicate patients have no disability and the worst score is 6.
Measured: 3 months
Secondary outcomes (2)
hemorrhagic rate
based on repeat MRI
Measured: 3 months
Stroke
based on MRI
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 posted20 Nov 2018
- Study start1 Sep 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Venous 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Saadatnia, Isfahan University of Medical Sciences
- Investigators
- Mohammad Saadatnia, Prof, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747081
- Sponsor's protocol ID
- Isfahan Stroke Unit
- Status last verified
- Nov 2018
- First submitted
- 13 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
PubMed 21830957
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Treatment Outcomes in CVT Patients Who Treated With Warfarin and Rivaroxaban in Isfahan, Iran
- ClinicalTrials.gov ID
- NCT03747081
- Acronym / sponsor ID
- Isfahan Stroke Unit
- Conditions
- Cerebral Venous Thrombosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 20 Nov 2018 (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.
With regard to Cerebral Venous Thrombosis (CVT) importance as a life threatening disease, specific care is necessary, Known anti-coagulants have limitations.Vitamin K antagonists such as Warfarin, require laboratory monitoring and exact administration starting and maintenance dose. although Rivaroxaban(selective and direct Xa factor antagonist ) has no monitoring and no drug interaction. This study aim to focus on efficacy of Warfarin versus Rivaroxaban.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivoroxaban | Experimental | Drug: RivaroxabanPatients would be administered Enoxaparine (60 mg/SC/BID)in first day, after dicontinuing Enoxaparin in second day, Rivoroxaban 20 mg per day will use. .it would be given once a day.The total duration of Rivoroxaban would be 3 months. |
| warfarin | Active comparator | Drug: WarfarinPatients would be administered Warfarin with overlap of Enoxaparine utill INR adjust to 2-3 then enoxaparine will disconstinue.it would be given once a day.The total duration of Warfarin would be 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patients suffering from renal failure(GFR<30) Patients
- Patients with contraindications for oral anticoagulation
- Patient who having pregnancy
- Uncooperative patient for completing the course of treatment
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 |
|---|---|---|
| RivaroxabanAlso: XareltoRivaroxaban will administrate to patient with CVT. In first day, enoxaparin is injected to patients and the next day, patients will receive Rivaroxaban and enoxaparin discontinue. Then, patients receive Rivaroxaban for 3 months daily. | Drug | Rivoroxaban |
| WarfarinAlso: CoumadinWarfarin as a antocoagolant drug will administrate to patient with CVT. In first day, Warfarin plus enoxaparin until adjusting INR index to 2-3. Then, patients receive warfarin for 3 months daily. | Drug | warfarin |
Primary outcome
Modified Rankin Scale
Time frame: 3 months
based on disability grade(0-6). 0 indicate patients have no disability and the worst score is 6.
2 secondary outcomes
hemorrhagic rate
Time frame: 3 months
Stroke
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Background: PubMed 21830957Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
- Individual participant dataSharing planned: No
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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.
Mohammad Saadatnia, Prof principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rivaroxaban and Warfarin in people with Cerebral Venous Thrombosis, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 0 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Nov 2018. 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 Iran. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Javad Farajpour Khanaposhtani, MD (00989193967294, mjf.khp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03747081, which also lists 1 linked publication.
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 20 Nov 2018.