CLINICAL TRIALS PROFILE FOR PHYTONADIONE

All Clinical Trials for PHYTONADIONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00905229 ↗	Comparing Different Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery	Withdrawn	HaEmek Medical Center, Israel	N/A	2009-05-01	It is well known that femoral neck fractures carry a significant increase in patients' mortality and that surgical intervention is the preferred treatment. Any delay in operating on such patients would inevitably increase their risk of developing complications. One of the reasons for such unintentional delay would be the hypercoagulative status of patients taking warfarin. The CHEST 2008 guidelines suggest reversing warfarin with Vitamin K for patients who need urgent operation. The aim of this study is to compare different roots and doses of Vitamin K.
NCT01474460 ↗	Use of Phytonadione to Reduce International Normalized Ratio (INR) Variability in Patients on Long-term Warfarin Therapy	Completed	James A. Haley Veterans Administration Hospital	N/A	2011-09-01	Background: Warfarin is used as an anti-coagulant in patients at risk of developing thrombosis. It has a narrow therapeutic index necessitating close monitoring of International Normalized Ratio (INR). According to a meta-analysis, patients were in therapeutic range only 63.6% of the time. This increases the risk of bleeding or thrombosis. Various retrospective and prospective studies have looked at supplementation with phytonadione in these patients to reduce the variability of INR showing an improvement in variability. Most of these studies have only been done in a small number of patients already on warfarin therapy. This study will focus on patients newly starting warfarin therapy. Methods: This study is a prospective, randomized, controlled trial performed at James A. Haley Veterans' Hospital (JAHVA). Patients who meet criteria and sign informed consent will receive either phytonadione with warfarin or warfarin alone. Based on a power calculation for 80%, a total of 370 patients will be enrolled (185 participants in each arm). Participants will be randomized to either intervention or control. Intervention group participants will be prescribed their usual starting dose of warfarin along with 200 mcg phytonadione by mouth daily. Control group participants will be prescribed their usual starting dose of warfarin. Both groups will follow the usual standard of care. They will come in for a follow-up INR and warfarin dose titration at least once per week until therapeutic, and then as instructed up to every 6 weeks thereafter. Both groups will participate in anticoagulation clinic activities that constitute the current standard of care. Intervention will last for a total of 6 months for each participant once enrolled. Hypothesis:Participants in the intervention group being supplemented with 200mcg of phytonadione will spend more total time with a therapeutic INR than participants in the control group.
NCT01528800 ↗	Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients	Completed	Kingston General Hospital	Phase 2	2012-11-01	The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo.
NCT01528800 ↗	Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients	Completed	Dr. Rachel Holden	Phase 2	2012-11-01	The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Federal University of São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.

Clinical Trial Conditions for PHYTONADIONE

Condition Name

Condition Name for PHYTONADIONE
Intervention	Trials
Atrial Fibrillation	2
Coagulation Delay	1
Complications	1
End Stage Renal Failure on Dialysis	1

Condition MeSH

Condition MeSH for PHYTONADIONE
Intervention	Trials
Kidney Failure, Chronic	2
Atrial Fibrillation	2
Kidney Diseases	1
Coronary Artery Disease	1

Clinical Trial Locations for PHYTONADIONE

Trials by Country

Trials by Country for PHYTONADIONE
Location	Trials
Australia	4
Canada	2
United States	2
New Zealand	1
Israel	1

Trials by US State

Trials by US State for PHYTONADIONE
Location	Trials
Michigan	1
Florida	1

Clinical Trial Progress for PHYTONADIONE

Clinical Trial Phase

Clinical Trial Phase for PHYTONADIONE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for PHYTONADIONE
Clinical Trial Phase	Trials
Completed	4
Recruiting	2
Withdrawn	1

Clinical Trial Sponsors for PHYTONADIONE

Sponsor Name

Sponsor Name for PHYTONADIONE
Sponsor	Trials
Dr. Rachel Holden	1
Fundação de Amparo à Pesquisa do Estado de São Paulo	1
Federal University of São Paulo	1

Sponsor Type

Sponsor Type for PHYTONADIONE
Sponsor	Trials
Other	11
U.S. Fed	1