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

NCT03191305 | Unknown DMC

• 1 other identifier: FUI/CTR/2017/2
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Conditions

Cerebral Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

• Hemorrhage or Recurrent CVT based on repeat MRI.

  Outcome measures will include any hemorrhage or recurrent CVT based on repeat MRI.

  6 months

Secondary Outcomes (1)

• Cost

  6 months

Study Arms (2)

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.

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.

Drug: Rivoroxaban

Interventions

Coumadin DRUG

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.

Coumadin Group

Rivoroxaban DRUG

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.

Rivoroxaban Group

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients of either gender Age between 13 years and 50 years Patients with proven CVT on neuro imaging (CTV, o MRV) -

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation University Islamabad: lead
• Shaheed Zulfiqar Ali Bhutto Medical University: collaborator

Related Publications (5)

• 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.

  PMID: 15858188 BACKGROUND

• F. 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

• 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.

  PMID: 21128814 BACKGROUND

• 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.

  PMID: 21830957 BACKGROUND

• Anticoli S, Pezzella FR, Scifoni G, et al. Treatment of Cerebral Venous Thrombosis with Rivaroxaban. J Biomedical Sci.

  BACKGROUND

MeSH Terms

Conditions

Intracranial Thrombosis

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Saira Saad, MBBS,MRCP,FCPS(Neurology)

CONTACT

+92 334 9555 456; sairaiqbl@hotmail.com

Haris Majid, MBBS,FCPS(Neurology)

CONTACT

+92 333 516 3322; harismajid@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only Participants would not know about the any other choice of the Drug available.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: August 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share