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Rivaroxaban for Antiphospholipid Antibody Syndrome (RAPS)

Primary Purpose

Antiphospholipid Antibody Syndrome

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Rivaroxaban
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Antiphospholipid Antibody Syndrome focused on measuring Antiphospholipid Antibody Syndrome, Rivaroxaban, Thromboembolism, Bleeding, Feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Prior objectively-confirmed venous thrombosis, irrespective of history of arterial thrombosis
  • Two or more prior positive APS serological evaluations at least 12 weeks apart
  • Current treatment with warfarin administered to achieve an INR of 2.0 to 3.0, rivaroxaban or dabigatran at any dose currently used for secondary prophylaxis of thrombosis, or short term therapeutic dose LMWH (for example, for the treatment of recently diagnosed deep vein thrombosis). Patients not currently receiving anticoagulation but in whom anticoagulation is mandated, may also be enrolled if a 20 mg rivaroxaban dose would be appropriate

Exclusion Criteria:

  • Prior recurrent thrombosis while taking warfarin with a demonstrated INR of 2.0 to 3.0, or prior recurrent thrombosis while receiving dabigatran or rivaroxaban
  • History of isolated arterial thrombosis (no history of venous thrombosis) pending CTA approval by Health Canada
  • Need for continued treatment with both aspirin (irrespective of dose) AND clopidogrel
  • Pregnancy or planned pregnancy during the study period; women who may become pregnant will be required to utilize reliable contraceptive measures while on study drug
  • Chronic kidney disease with calculated GFR < 30mL/min
  • Geographic inaccessibility
  • Age < 18 years
  • Inability or failure to provide informed consent

Sites / Locations

  • University of Alberta Hospital
  • Queen Elizabeth II Hospital
  • Hamilton General Hospital
  • St. Joseph's Healthcare Hamilton
  • The Ottawa Hospital
  • Jewish General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rivaroxaban

Arm Description

Rivaroxaban 20mg po daily

Outcomes

Primary Outcome Measures

Feasibility of identification for enrolment
The investigators define success as the ability to identify 150 eligible patients at 6 clinical centres over 18 months.
Feasibility of Consent
The investigators define success as a consent rate of 90% (thus, if we identify 150 patients, at least 135 will provide consent).
Compliance
The investigators define success as a patient missing fewer than 5% of days with pill administrations, as measured by pill counts.

Secondary Outcome Measures

Bleeding
The investigators will collect and report the rates of minor bleeding (clinically apparent bleeding that does not meet the criteria for major), and major and fatal bleeding. Major bleeding will be defined by International Society of Thrombosis and Hemostasis criteria.
Thrombosis
The investigators will collect and report the rates of objectively-confirmed venous and arterial thrombosis.

Full Information

First Posted
April 14, 2014
Last Updated
October 16, 2017
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Heart and Stroke Foundation of Canada, Bayer, Hamilton Health Sciences Corporation, Jewish General Hospital, University of Alberta, The Ottawa Hospital, Queen Elizabeth II Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02116036
Brief Title
Rivaroxaban for Antiphospholipid Antibody Syndrome
Acronym
RAPS
Official Title
Rivaroxaban in Antiphospholipid Syndrome Pilot Study: A Multicenter Feasibility Study of Rivaroxaban for Patients With Antiphospholipid Syndrome and Prior Arterial or Venous Thrombosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Heart and Stroke Foundation of Canada, Bayer, Hamilton Health Sciences Corporation, Jewish General Hospital, University of Alberta, The Ottawa Hospital, Queen Elizabeth II Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The antiphospholipid antibody syndrome (APS) is a syndrome associated with excessive blood clotting (thrombosis). APS is among the most common cause of heart attack and stroke in patients under the age of 50 and is particularly prevalent in patients with autoimmune conditions. Patients with APS and prior thrombosis require lifelong anticoagulant therapy to prevent recurrent clots; such therapy is currently provided with warfarin. Warfarin requires frequent bloodwork monitoring, and many medications or foods can alter its effect, which can put people either at increased risk for clotting or bleeding. Rivaroxaban is a new mediation that prevents blood clots that does not require bloodwork monitoring and that has fewer interactions. This study is a pilot feasibility study which will: 1) examine our ability to identify 150 eligible APS patients; 2) measure our ability to obtain consent from 135 of these patients; and 3) test our hypothesis that we can obtain 95% compliance with daily rivaroxaban administration. The investigators propose to treat eligible patients with rivaroxaban 20 mg once daily. Patients will be followed for a minimum of one year and their rates of bleeding and thrombosis will be monitored as secondary outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antiphospholipid Antibody Syndrome
Keywords
Antiphospholipid Antibody Syndrome, Rivaroxaban, Thromboembolism, Bleeding, Feasibility

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban
Arm Type
Experimental
Arm Description
Rivaroxaban 20mg po daily
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Xarelto
Primary Outcome Measure Information:
Title
Feasibility of identification for enrolment
Description
The investigators define success as the ability to identify 150 eligible patients at 6 clinical centres over 18 months.
Time Frame
18 months
Title
Feasibility of Consent
Description
The investigators define success as a consent rate of 90% (thus, if we identify 150 patients, at least 135 will provide consent).
Time Frame
18 months
Title
Compliance
Description
The investigators define success as a patient missing fewer than 5% of days with pill administrations, as measured by pill counts.
Time Frame
Minimum of one year for all subjects
Secondary Outcome Measure Information:
Title
Bleeding
Description
The investigators will collect and report the rates of minor bleeding (clinically apparent bleeding that does not meet the criteria for major), and major and fatal bleeding. Major bleeding will be defined by International Society of Thrombosis and Hemostasis criteria.
Time Frame
Minimum of one year for all subjects
Title
Thrombosis
Description
The investigators will collect and report the rates of objectively-confirmed venous and arterial thrombosis.
Time Frame
Minimum of one year for all subjects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prior objectively-confirmed venous thrombosis, irrespective of history of arterial thrombosis Two or more prior positive APS serological evaluations at least 12 weeks apart Current treatment with warfarin administered to achieve an INR of 2.0 to 3.0, rivaroxaban or dabigatran at any dose currently used for secondary prophylaxis of thrombosis, or short term therapeutic dose LMWH (for example, for the treatment of recently diagnosed deep vein thrombosis). Patients not currently receiving anticoagulation but in whom anticoagulation is mandated, may also be enrolled if a 20 mg rivaroxaban dose would be appropriate Exclusion Criteria: Prior recurrent thrombosis while taking warfarin with a demonstrated INR of 2.0 to 3.0, or prior recurrent thrombosis while receiving dabigatran or rivaroxaban History of isolated arterial thrombosis (no history of venous thrombosis) pending CTA approval by Health Canada Need for continued treatment with both aspirin (irrespective of dose) AND clopidogrel Pregnancy or planned pregnancy during the study period; women who may become pregnant will be required to utilize reliable contraceptive measures while on study drug Chronic kidney disease with calculated GFR < 30mL/min Geographic inaccessibility Age < 18 years Inability or failure to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly J Legault, MD
Organizational Affiliation
St. Joseph's Healthcare Hamilton, Hamilton Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark A Crowther, MD, MSc
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2P4
Country
Canada
Facility Name
Queen Elizabeth II Hospital
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32346486
Citation
Legault K, Blostein M, Carrier M, Khan S, Schulman S, Shivakumar S, Wu C, Crowther MA. A single-arm feasibility cohort study of rivaroxaban in antiphospholipid syndrome. Pilot Feasibility Stud. 2020 Apr 25;6:52. doi: 10.1186/s40814-020-00594-1. eCollection 2020. Erratum In: Pilot Feasibility Stud. 2020 May 18;6:67.
Results Reference
derived

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Rivaroxaban for Antiphospholipid Antibody Syndrome

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