Clinical Trials Logo
  1. Home
  2. Heparin-Induced Thrombocytopenia
  3. NCT01598168

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

Heparin-induced Thrombocytopenia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01598168
Study type Interventional
Source McMaster University
Contact
Status Terminated
Phase Phase 3
Start date January 2013
Completion date July 2015
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT00759083 - Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients Phase 4
Completed NCT00412464 - Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis Phase 1
Completed NCT00456326 - Heparin-Induced Thrombocytopenia Registry N/A
Terminated NCT00673439 - Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT) Phase 2
Active, not recruiting NCT00198575 - A Study on the Prevalence of Heparin-Induced Thrombocytopenia in Cardiovascular Patients N/A
Completed NCT00283322 - Heparin Antibodies in Intensive Care Unit Patients (HAICU) N/A
Not yet recruiting NCT05586854 - Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia N/A
Not yet recruiting NCT03269019 - Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia N/A
Not yet recruiting NCT06066762 - Argatroban Monitoring in Acute Suspected Heparin-induced Thrombocytopenia.
Terminated NCT03809481 - Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban Phase 3
Completed NCT05325346 - A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects Phase 1
Recruiting NCT02717039 - Pharmacogenomics of Heparin-Induced Thrombocytopenia
Completed NCT02526485 - Immunogenetics of Heparin-Induced Thrombocytopenia: Aim 2
Completed NCT00748839 - Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical N/A
Recruiting NCT05783895 - Comparison of Pre-test Probability Model for Heparin-induced Thrombocytopenia in Post-operative Cardiac Surgery
Not yet recruiting NCT04782843 - Evaluation of the Intra-observer Agreement of the HEP Score in Surgical Intensive Care.
Completed NCT00198588 - Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia Phase 3
Recruiting NCT04842760 - PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer
Completed NCT01654848 - Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients N/A
Withdrawn NCT00603824 - Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT) Phase 4