Comparison of the Efficacy of Rivroxaban to Coumadin( Warfarin ) in Cerebral Venous Thrombosis (CVT)

June 15, 2017 updated by: Foundation University Islamabad
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Saira Saad, MBBS,MRCP,FCPS(Neurology)
  • Phone Number: +92 334 9555 456
  • Email: sairaiqbl@hotmail.com

Study Contact Backup

  • Name: Haris Majid, MBBS,FCPS(Neurology)
  • Phone Number: +92 333 516 3322
  • Email: harismajid@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Coumadin Group
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.
Drug: Coumadin
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.
Active Comparator: Rivoroxaban Group
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.
Drug: Rivoroxaban
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost
Time Frame: 6 months
Comparison of cost of two treatment groups.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation University Islamabad

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shaheed Zulfiqar Ali Bhutto Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUI/CTR/2017/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Venous Thrombosis

Clinical Trials on Coumadin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings