Cerebral Venous ThrombosisCVTNCT03191305
Comparison of the Efficacy of Rivroxaban to Coumadin( Warfarin ) in Cerebral Venous Thrombosis
A study testing Coumadin and Rivoroxaban in people with Cerebral Venous Thrombosis, run by Foundation University Islamabad.
Trial summary
In past few years new anticoagulants have been developed which directly inhibit thrombin or factor X.factor x inhibitor is available in Pakistan. The superior efficacy of Rivroxaban has been shown in Deep Venous Thrombosis in EINSTEIN study (3).Its definite superiority in prevention of embolic stroke in nonvalvular… Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- Cerebral Venous Thrombosis
- What is being tested?
- Coumadin and Rivoroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Sep 2018
- 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 13 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients of either gender Age between 13 years and 50 years Patients with proven CVT on neuro imaging (CTV, o MRV) -
Who cannot join
- Patients suffering from Chronic Liver disesase Patients having contraindications for oral anticoagulation Patients suffering from hematological or brain malignancy Patients whose MRV and CTV do not support CVT
- -
Trial locations and contacts
No sites are listed yet.
About this study
In past few years new anticoagulants have been developed which directly inhibit thrombin or factor X.factor x inhibitor is available in Pakistan. The superior efficacy of Rivroxaban has been shown in Deep Venous Thrombosis in EINSTEIN study (3).Its definite superiority in prevention of embolic stroke in nonvalvular atrial fibrillation is evidenced by the study ROCKET AF (4). With Rivroxaban no monitoring is required, and also there are no drug interactions .There are few pilot studies of using Rivroxaban in cerebral venous thrombosis. This study is therefore required to find its efficacy in CVT patients as well as its comparison with Coumadin
Read the detailed description
Cerebral venous thrombosis is rare form of stroke, accounting .5 to 1% only (1)Exact estimate for Pakistani population is not known Mubarak et al described 6- year imaging incidence and prevalence of CVST to be 10.22% and 11.055% respectively(2) .Majority of cerebral venous stroke patients are females in reproductive age. Coumadin is one of the notorious drugs to be used in pregnancy categorized as X. it also has many drug interactions .and there are diet restrictions too being on Coumadin. It also requires maintanence of prothrombin time in certain range which means patient has to go under phlebotomy at least twice a month. Moreover not all laboratories are well equipped resulting in poor test sensitivity. and at times clinicians keep patients on suboptimum doses for fear of bleeding ending with poor efficacy.
In past few years new anticoagulants have been developed which directly inhibit thrombin or factor X.factor x inhibitor is available in Pakistan.
The superior efficacy of Rivroxaban has been shown in Deep Venous Thrombosis in EINSTEIN study (3).Its definite superiority in prevention of embolic stroke in nonvalvular atrial fibrillation is evidenced by the study ROCKET AF (4). With Rivroxaban no monitoring is required, and also there are no drug interactions .There are few pilot studies of using Rivroxaban in cerebral venous thrombosis. This study is therefore required to find its efficacy in CVT patients as well as its comparison with Coumadin .
OBJECTIVE To Compare the efficacy of Rivroxaban to Warfarin in Cerebral Venous Thrombosis MATERIAL AND METHODS STUDY DESIGN: Quasi Experimental; Descriptive cross sectional
DURATION OF STUDY:
6 months to 1 year
SAMLE SIZE :
50 patients SAMPLING TECHNIQUE : Consecutive (non probability) sampling.
INCLUSION CRITERIA:
Patients of either gender Age between 13 years and 50 years Patients with proven CVT on neuro imaging (CTV, o MRV)
EXCLUSION CRITERIA:
Patients suffering from Chronic Liver disesase Patients having contraindications for oral anticoagulation Patients suffering from hematological or brain malignancy Patients whose MRV and CTV do not support CVT
DATA COLLECTION PROCEDURE After taking permission from hospital ethical review committee , All patients with confirmed CVT based on established criteria using any NOAC or WARFARIN presenting to PIMS or FFH hospitals will be enrolled. Data will be obtained by retrospective manner if they are using anticoagulants for more than 6 months. If patients are using anticoagulants for less than 6 months, they will be enrolled and followed up for six months.
DATA ANALYSIS The data will be analyzed using SPSS version 16.0. Descriptive analysis will be done and reported as mean ± SD for continuous variables like age whereas frequencies and percentages will be calculated for categorical variables such as gender, individual risk factors.
P-value ≤ 0.05 will be significant. Results will be presented in tabulated or graphical forms.
Outcome measures Outcome measures will include any hemorrhage or recurrent CVT based on repeat MRI.
MRs Scale Secondary Outcome Comparison of cost of two treatment groups.
- Conditions
- Cerebral Venous Thrombosis
- Being tested
- Coumadin, Rivoroxaban
- Medical subject headings
- Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoumadinDrug
Patients in Coumadin Group would be administered Coumadin with overlap of heparin for first two days followed by Coumadin given orally ,dose being adjusted according to INR .The INR range would be between 2-3.it would be given once a day. The total duration Of coumadin would be six months.
RivoroxabanDrug
The dose protocol would be similar to the one used in Deep Venous Thrombosis. 15 mg PO q12hr for 21 days with food, Then 20 mg PO qDay for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Coumadin Group | Active comparator | Patients in Coumadin Group would be administered Coumadin with overlap of heparin for first two days followed by Coumadin given orally ,dose being adjusted according to INR .The INR range would be between 2-3.it would be given once a day.The total duration OFf coumadin would be six months. Receives: Drug: Coumadin |
| Rivoroxaban Group | Active comparator | The dose protocol would be similar to the one used in Deep Venous Thrombosis. 15 mg PO q12hr for 21 days with food, THEN 20 mg PO qDay for 6 months. Receives: Drug: Rivoroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhage or Recurrent CVT based on repeat MRI.
Outcome measures will include any hemorrhage or recurrent CVT based on repeat MRI.
Measured: 6 months
Secondary outcomes (1)
Cost
Comparison of cost of two treatment groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study startAug 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients of CVT from Fauji Foundation would be be in Coumadin Arm ,and patients of CVT from Pakistan Institute of Medical Sciences Hospital would be in Rivroxaban arm.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Collaborators
- Shaheed Zulfiqar Ali Bhutto Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191305
- Sponsor's protocol ID
- FUI/CTR/2017/2
- Acronym
- CVT
- Status last verified
- Jun 2017
- First submitted
- 15 Jun 2017
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stam J. Thrombosis of the cerebral veins and sinuses. N Engl J Med. 2005 Apr 28;352(17):1791-8. doi: 10.1056/NEJMra042354. No abstract available.
PubMed 15858188F. Mubarak, A. Muhammad, Cerebral venous sinus thrombosis: Incidence, prevalence and patterns of neurological involvement: a retrospective study from Pakistani population European society of Radiology .
EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.
PubMed 21128814Patel 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 21830957Anticoli S, Pezzella FR, Scifoni G, et al. Treatment of Cerebral Venous Thrombosis with Rivaroxaban. J Biomedical Sci.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Rivroxaban to Coumadin( Warfarin ) in Cerebral Venous Thrombosis
- ClinicalTrials.gov ID
- NCT03191305
- Acronym / sponsor ID
- CVT / FUI/CTR/2017/2
- Conditions
- Cerebral Venous Thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Collaborators
- Shaheed Zulfiqar Ali Bhutto Medical University
- Study start
- Aug 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 Jun 2017 (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.
In past few years new anticoagulants have been developed which directly inhibit thrombin or factor X.factor x inhibitor is available in Pakistan. The superior efficacy of Rivroxaban has been shown in Deep Venous Thrombosis in EINSTEIN study (3).Its definite superiority in prevention of embolic stroke in nonvalvular atrial fibrillation is evidenced by the study ROCKET AF (4). With Rivroxaban no monitoring is required, and also there are no drug interactions .There are few pilot studies of using Rivroxaban in cerebral venous thrombosis. This study is therefore required to find its efficacy in CVT patients as well as its comparison with Coumadin
Detailed description
Cerebral venous thrombosis is rare form of stroke, accounting .5 to 1% only (1)Exact estimate for Pakistani population is not known Mubarak et al described 6- year imaging incidence and prevalence of CVST to be 10.22% and 11.055% respectively(2) .Majority of cerebral venous stroke patients are females in reproductive age. Coumadin is one of the notorious drugs to be used in pregnancy categorized as X. it also has many drug interactions .and there are diet restrictions too being on Coumadin. It also requires maintanence of prothrombin time in certain range which means patient has to go under phlebotomy at least twice a month. Moreover not all laboratories are well equipped resulting in poor test sensitivity. and at times clinicians keep patients on suboptimum doses for fear of bleeding ending with poor efficacy.
In past few years new anticoagulants have been developed which directly inhibit thrombin or factor X.factor x inhibitor is available in Pakistan.
The superior efficacy of Rivroxaban has been shown in Deep Venous Thrombosis in EINSTEIN study (3).Its definite superiority in prevention of embolic stroke in nonvalvular atrial fibrillation is evidenced by the study ROCKET AF (4). With Rivroxaban no monitoring is required, and also there are no drug interactions .There are few pilot studies of using Rivroxaban in cerebral venous thrombosis. This study is therefore required to find its efficacy in CVT patients as well as its comparison with Coumadin .
OBJECTIVE To Compare the efficacy of Rivroxaban to Warfarin in Cerebral Venous Thrombosis MATERIAL AND METHODS STUDY DESIGN: Quasi Experimental; Descriptive cross sectional
DURATION OF STUDY:
6 months to 1 year
SAMLE SIZE :
50 patients SAMPLING TECHNIQUE : Consecutive (non probability) sampling.
INCLUSION CRITERIA:
Patients of either gender Age between 13 years and 50 years Patients with proven CVT on neuro imaging (CTV, o MRV)
EXCLUSION CRITERIA:
Patients suffering from Chronic Liver disesase Patients having contraindications for oral anticoagulation Patients suffering from hematological or brain malignancy Patients whose MRV and CTV do not support CVT
DATA COLLECTION PROCEDURE After taking permission from hospital ethical review committee , All patients with confirmed CVT based on established criteria using any NOAC or WARFARIN presenting to PIMS or FFH hospitals will be enrolled. Data will be obtained by retrospective manner if they are using anticoagulants for more than 6 months. If patients are using anticoagulants for less than 6 months, they will be enrolled and followed up for six months.
DATA ANALYSIS The data will be analyzed using SPSS version 16.0. Descriptive analysis will be done and reported as mean ± SD for continuous variables like age whereas frequencies and percentages will be calculated for categorical variables such as gender, individual risk factors.
P-value ≤ 0.05 will be significant. Results will be presented in tabulated or graphical forms.
Outcome measures Outcome measures will include any hemorrhage or recurrent CVT based on repeat MRI.
MRs Scale Secondary Outcome Comparison of cost of two treatment groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients of CVT from Fauji Foundation would be be in Coumadin Arm ,and patients of CVT from Pakistan Institute of Medical Sciences Hospital would be in Rivroxaban arm.
| Arm | Type | Receives |
|---|---|---|
| Coumadin Group | Active comparator | Drug: CoumadinPatients in Coumadin Group would be administered Coumadin with overlap of heparin for first two days followed by Coumadin given orally ,dose being adjusted according to INR .The INR range would be between 2-3.it would be given once a day.The total duration OFf coumadin would be six months. |
| Rivoroxaban Group | Active comparator | Drug: RivoroxabanThe dose protocol would be similar to the one used in Deep Venous Thrombosis. 15 mg PO q12hr for 21 days with food, THEN 20 mg PO qDay for 6 months. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients of either gender Age between 13 years and 50 years Patients with proven CVT on neuro imaging (CTV, o MRV) -
Key exclusion criteria (2 listed)
- Patients suffering from Chronic Liver disesase Patients having contraindications for oral anticoagulation Patients suffering from hematological or brain malignancy Patients whose MRV and CTV do not support CVT
- -
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 |
|---|---|---|
| CoumadinPatients in Coumadin Group would be administered Coumadin with overlap of heparin for first two days followed by Coumadin given orally ,dose being adjusted according to INR .The INR range would be between 2-3.it would be given once a day. The total duration Of coumadin would be six months. | Drug | Coumadin Group |
| RivoroxabanThe dose protocol would be similar to the one used in Deep Venous Thrombosis. 15 mg PO q12hr for 21 days with food, Then 20 mg PO qDay for 6 months. | Drug | Rivoroxaban Group |
Primary outcome
Hemorrhage or Recurrent CVT based on repeat MRI.
Time frame: 6 months
Outcome measures will include any hemorrhage or recurrent CVT based on repeat MRI.
1 secondary outcome
Cost
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Background: PubMed 15858188Stam J. Thrombosis of the cerebral veins and sinuses. N Engl J Med. 2005 Apr 28;352(17):1791-8. doi: 10.1056/NEJMra042354. No abstract available.
- BackgroundF. Mubarak, A. Muhammad, Cerebral venous sinus thrombosis: Incidence, prevalence and patterns of neurological involvement: a retrospective study from Pakistani population European society of Radiology .
- Background: PubMed 21128814EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.
- 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.
- BackgroundAnticoli S, Pezzella FR, Scifoni G, et al. Treatment of Cerebral Venous Thrombosis with Rivaroxaban. J Biomedical Sci.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Coumadin and Rivoroxaban in people with Cerebral Venous Thrombosis, run by Foundation University Islamabad.
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 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: status not confirmed, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saira Saad, MBBS,MRCP,FCPS(Neurology) (+92 334 9555 456, sairaiqbl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhage or Recurrent CVT based on repeat MRI. (time frame: 6 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 NCT03191305, which also lists 5 linked publications.
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 19 Jun 2017.