Clinical Trials Logo

Clinical Trial Summary

This research study is studying a drug as a possible treatment for heparin induced thrombocytopenia (HIT) or Heparin-induced Thrombocytopenia and Thrombosis (HITT). The drug involved in this study is apixaban.


Clinical Trial Description

This research study is a Phase II clinical trial. The FDA (the U.S. Food and Drug Administration) has not approved apixaban as a treatment option for this specific disease but it has been approved for other uses. HIT and HITT are common and severe complications of heparin therapy. Once patients are diagnosed with either one of these, they are typically switched to a non-heparin anticoagulant (a type of drug that thins your blood). As of now the only drug that is FDA approved for HIT or HITT is argatroban, which is administered continuously through an IV over multiple days and is extremely costly. In this research study, the investigators are researching the activity and tolerability of apixaban in participants with HIT or HITT. The investigators believe that apixaban will work just as well as argatroban and will be more convenient for this population. The oral route of apixaban allows for the potential outpatient treatment of HIT or HITT which is both convenient and less expensive than treatment with argatroban. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03594045
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Terminated
Phase Phase 2
Start date December 18, 2018
Completion date October 30, 2019

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Withdrawn NCT00759083 - Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients Phase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
Terminated NCT01598168 - Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia Phase 3
Completed NCT01654848 - Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients N/A