Prevention of Recurrence After Thrombolysis in Acute Ilio... | NCT01986192

Studies
Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study

NCT01986192

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Nov 19, 2014Estimated

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Ileofemoral Deep Vein Thrombosis

Interventions

rivaroxaban
Warfarin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Feb 2015Estimated

Completion Date

Nov 2015Estimated

First Submitted Date

Nov 11, 2013

First Submission Date that Met QC Criteria

Nov 15, 2013

First Posted Date

Nov 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2014

Last Update Posted Date

Nov 19, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seung-Kee Min, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Daegu Catholic University Medical Center	OTHER
Seoul National University Bundang Hospital	OTHER
SMG-SNU Boramae Medical Center	OTHER
The Catholic University of Korea

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The EINSTEIN program showed that oral rivaroxaban is effective and safe treatment for prevention of recurrent venous thrombosis and pulmonary embolism in deep vein thrombosis patients and FDA approved the rivaroxaban for prevention and treatment of deep vein thrombosis (Nov 2 2012).

Recently, catheter-directed thrombolysis can significantly reduce post-thrombotic syndrome, and more and more centers introduce catheter-directed thrombolysis to treat proximal (i.e, iliofemoral) DVT. However, the EINSTEIN program excluded patients with deep vein thrombosis if they had been treated with a vena cava filter or a fibrinolytic agent for the current episode of thrombosis.

Although catheter-directed thrombolysis (CDT) or pharmacomechanical thrombolysis has now been accepted as a treatment of choice in iliofemoral DVT, thrombolysis has an inherent risk of bleeding. Therefore, patients who have completed CDT and have been stabilized at least 24 hours after thrombolysis will be included in this study.

Also, the investigators want to explore the efficacy and safety of rivaroxaban in patients with iliofemoral DVT after catheter-directed thrombolysis and/or a vena cava filter insertion and/or venous stent insertion and compare these outcomes with warfarin treatment alone.

This study will be a pilot study to establish the safety and efficacy parameters for further studies.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rivaroxaban	Experimental	Rivaroxaban 15mg bid for 3 weeks and 20mg qd for 6 months	Drug: rivaroxaban
warfarin	Active Comparator	Enoxaparin 1mg/kg bid overlapping with warfarin (target PT INR 2.0-3.0) for 6 months	Drug: Warfarin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rivaroxaban	Drug		rivaroxaban	xarelto
Warfarin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recurrence rate	to compare recurrence rate within 6 months after thrombolysis in iliofemoral deep vein thrombosis with warfarin prophylaxis	six month

Secondary Outcomes

Measure	Description	Time Frame
vascular events	All-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack or systemic embolism)	six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-75 years
Onset of symptoms within the past 21 days
Objectively verified (by CT venography) deep vein thrombosis localized in the iliofemoral segment
Complete catheter-directed thrombolysis and/or a vena cava and/or venous stent insertion
Informed consent

Exclusion Criteria:

Incomplete catheter-directed thrombolysis
If patients received more than a single dose of a warfarin before randomization
contraindicating anticoagulant treatment
another indication for a warfarin
an estimated glomerular filtration rate by MDRD equation <30ml/min
clinically significant liver disease (acute hepatitis, chronic active hepatitis, cirrhosis)
Alanine aminotransferase > 3-time higher than upper limit of the normal range
Bacterial endocarditis
Active bleeding or high risk of bleeding
Pregnancy or breast-feeding
Concomitant use of strong cytochrome P-450 3A4 inhibitors or inducers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seung-Kee Min, MD	Contact	02-2072-0297		skminmd@yahoo.com

Overall Officials

Name	Affiliation	Role
Seung-Kee Min, MD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110-744	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000069552	Rivaroxaban
D014859	Warfarin

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines

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Browse Branches

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