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

Phase

Condition

Thrombocytopenia And Thrombocytopenia Prevention

Platelet Disorders

Thrombosis

Treatment

N/A

Clinical Study ID

NCT01598168

2012-02-09

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 aclinically relevant bleeding risk
Inability to take oral medications.
Ongoing requirement for systemic treatment with azole-antimycotics (exceptfluconazole) or HIV-protease inhibitors or strong CYP3A4 inducers
Clinically significant active bleeding or lesions at increased risk for bleedingwithin the last 6 months
Platelet count less than 80 and an ongoing need for antiplatelet therapy may beexcluded at the discretion of the investigator
Pregnant or a woman of child-bearing potential not using an adequate birth controlmethod
Hypersensitivity to rivaroxaban or to any ingredient in the formulation.

Study Design

January 01, 2013

July 31, 2015

Study 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.

Connect with a study center

Hamilton Health Sciences - Juravinski Site
Hamilton, Ontario L8V 1C3
Canada
Site Not Available

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