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

NCT01598168 | Terminated Phase 3 DMC

• 1 other identifier: 2012-02-09
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Heparin-induced Thrombocytopenia

Keywords

rivaroxaban; treatment; venous thromboembolism; arterial thromboembolism; thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Incidence of new symptomatic venous and arterial thromboembolism in the study population.

  30 days

Secondary Outcomes (5)

• Incidence of symptomatic venous and arterial thromboembolism and major bleeding in patients while on-treatment with rivaroxaban.

  30 days

• Duration of time to platelet recovery in patients with Serotonin Release Assay (SRA) confirmed HIT

  30 days

• Incidence of venous and arterial thromboembolism in patients with SRA confirmed HIT who receive rivaroxaban.

  30 days

• Major bleeding in the entire study population and in patients with SRA confirmed HIT who receive rivaroxaban.

  30 days

• To collect data to prospectively validate a new clinical prediction rule for HIT

  30 days

Study Arms (1)

Rivaroxaban

EXPERIMENTAL

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

Interventions

Rivaroxaban DRUG

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.

Also known as: Xarelto

Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Hamilton Health Sciences - Juravinski Site

Hamilton, Ontario, L8V 1C3, Canada

Location

MeSH Terms

Conditions

Venous Thromboembolism; Thrombocytopenia

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lori-Ann Linkins, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 15, 2012
• Study Start: January 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

CA (1)