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

Sponsor

McMaster University (Other)

Overall Status

Terminated

CT.gov ID

NCT01598168

Collaborator

(none)

Enrollment

Location

Arm

29.9

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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

Actual Enrollment :

22 participants

Allocation:

N/A

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 :

Jan 1, 2013

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

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 Names: Xarelto

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 Names:

Xarelto

Outcome Measures

Primary Outcome Measures

Incidence of new symptomatic venous and arterial thromboembolism in the study population. [30 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.