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Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT01598168
Recruitment Status : Terminated (slow recruitment)
First Posted : May 15, 2012
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Heparin is an anticoagulant (blood thinner) that is commonly used to treat patients with heart attacks and patients with blood clots in their legs or lungs (venous thrombosis). Some patients develop an allergic reaction to heparin, a condition called heparin-induced thrombocytopenia (HIT). HIT makes blood clot, which is the opposite of what heparin was designed to do. These blood clots can lead to heart attacks, strokes, limb amputations, and death. The objective of this 200 patient study is to determine if a new blood thinner called rivaroxaban (Xarelto) can be used to treat HIT. Rivaroxaban can be taken by mouth, does not require blood testing, and had a low risk of bleeding when it was used to treat blood clots in other clinical trials. If this study shows that rivaroxaban can be used to treat HIT, there will be two very important benefits. For patients with HIT, the benefit will be having a safe, and easy-to-use drug to protect them from developing further life or limb-threatening blood clots. For the Canadian health care system, the benefit will be having a drug that is much less expensive than the drugs currently used to treat HIT.

Condition or disease Intervention/treatment Phase
Heparin-induced Thrombocytopenia Drug: Rivaroxaban Phase 3

Detailed Description:
Consecutive adult patients with an intermediate or high clinical probability for HIT (according to the clinical prediction rule called the "4T's Score) will receive rivaroxaban 15 mg bid while awaiting confirmation or exclusion of HIT by the local laboratory assay. Patients who are confirmed to have HIT by the local laboratory assay will continue to receive rivaroxaban 15 mg bid until their platelet count ≥ 150 or until end of study (Day 30). At the time of platelet count recovery (typically 4-7 days), they will be transitioned to a maintenance dose of rivaroxaban (20 mg od) for a maximum of 30 days.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia
Study Start Date : January 2013
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Rivaroxaban
Rivaroxaban 15 mg bid until HIT excluded by local laboratory assay or platelets recovered. If HIT positive and platelets have recovered, patients will receive rivaroxaban 20 mg od until Day 30.
Drug: Rivaroxaban
Rivaroxaban 15 mg bid until HIT excluded by local laboratory assay or platelets recovered. If HIT positive and platelets have recovered, patients will receive rivaroxaban 20 mg od until Day 30.
Other Name: Xarelto


Outcome Measures

Primary Outcome Measures :
  1. Incidence of new symptomatic venous and arterial thromboembolism in the study population. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Incidence of symptomatic venous and arterial thromboembolism and major bleeding in patients while on-treatment with rivaroxaban. [ Time Frame: 30 days ]
  2. Duration of time to platelet recovery in patients with Serotonin Release Assay (SRA) confirmed HIT [ Time Frame: 30 days ]
  3. Incidence of venous and arterial thromboembolism in patients with SRA confirmed HIT who receive rivaroxaban. [ Time Frame: 30 days ]
  4. Major bleeding in the entire study population and in patients with SRA confirmed HIT who receive rivaroxaban. [ Time Frame: 30 days ]
  5. To collect data to prospectively validate a new clinical prediction rule for HIT [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with 4T's Score greater than or equal to 4.

Exclusion Criteria:

  • Require ongoing anticoagulant therapy for a mechanical heart valve.
  • Severe renal insufficiency (CrCl<30 ml/min)
  • Hepatic disease (including Child-Pugh B and C) associated with coagulopathy and a clinically relevant bleeding risk
  • Inability to take oral medications.
  • Ongoing requirement for systemic treatment with azole-antimycotics (except fluconazole) or HIV-protease inhibitors or strong CYP3A4 inducers
  • Clinically significant active bleeding or lesions at increased risk for bleeding within the last 6 months
  • Platelet count less than 80 and an ongoing need for antiplatelet therapy may be excluded at the discretion of the investigator
  • Pregnant or a woman of child-bearing potential not using an adequate birth control method
  • Hypersensitivity to rivaroxaban or to any ingredient in the formulation.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598168


Locations
Canada, Ontario
Hamilton Health Sciences - Juravinski Site
Hamilton, Ontario, Canada, L8V 1C3
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Lori-Ann Linkins, MD McMaster University
More Information

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01598168     History of Changes
Other Study ID Numbers: 2012-02-09
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016

Keywords provided by McMaster University:
rivaroxaban
treatment
venous thromboembolism
arterial thromboembolism
thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Heparin
Rivaroxaban
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors