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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: McMaster University

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: McMaster University

Dates:
Date Received: May 11, 2012
Date Started: January 2013
Date Completion:
Last Updated: March 24, 2016
Last Verified: March 2016