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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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):
McMaster University

Tracking Information
First Submitted Date  ICMJE May 11, 2012
First Posted Date  ICMJE May 15, 2012
Last Update Posted Date March 25, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2012)
Incidence of new symptomatic venous and arterial thromboembolism in the study population. [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2012)
  • Incidence of symptomatic venous and arterial thromboembolism and major bleeding in patients while on-treatment with rivaroxaban. [ Time Frame: 30 days ]
  • Duration of time to platelet recovery in patients with Serotonin Release Assay (SRA) confirmed HIT [ Time Frame: 30 days ]
  • Incidence of venous and arterial thromboembolism in patients with SRA confirmed HIT who receive rivaroxaban. [ Time Frame: 30 days ]
  • Major bleeding in the entire study population and in patients with SRA confirmed HIT who receive rivaroxaban. [ Time Frame: 30 days ]
  • To collect data to prospectively validate a new clinical prediction rule for HIT [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia
Official Title  ICMJE Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heparin-induced Thrombocytopenia
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Rivaroxaban
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 24, 2016)
22
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2012)
200
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01598168
Other Study ID Numbers  ICMJE 2012-02-09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lori-Ann Linkins, MD McMaster University
PRS Account McMaster University
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP