Stroke Clinical Trial
Verified date | February 2014 |
Source | Academia Sinica, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Ministry of Health and Welfare |
Study type | Interventional |
Purpose:
Warfarin is now the most commonly used oral anticoagulant. This drug has inter-individual
variability due to the genetic polymorphisms in the warfarin metabolizing enzyme, CYP2C9 and
warfarin target, VKORC1. The investigators' team developed a pharmacogenetic dosing
algorithm which can predict patients required warfarin dose, thus could prevent warfarin
induced warfarin adverse events.
Methods:
The investigators recruited patients with indications for warfarin, the genotypes of VKORC1
and CYP2C9 were determined by the hospitals and verified by National Center for Genome
Medicine. The investigators then randomized the patients to one of three arms: 1. Warfarin
dose predicted by dosing algorithm developed by the International Warfarin pharmacogenetic
Consortium (IWPC), 2. Algorithm developed by the Taiwan Warfarin Consortium and 3. Standard
of care. The investigators aimed to determine whether using genetic dosing algorithm can
lead to more stable dose and safer use of the drug.
Status | Completed |
Enrollment | 300 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Patients must give their informed consent and complete the case report form. - Patients must be over the age of 20. - Patients have clinical indications for warfarin therapy but do not have any prior warfarin treatment. Exclusion Criteria: - Patients who did not complete the informed consent form or the CRF - Patients who are less than the age of 20. - Patients who had prior or is currently on warfarin treatment. - Patients who have hemorrhagic tendencies or hemorrhagic diseases defined as copious bleeding caused by viral or bacterial infections; cancer and hepatic dysfunction defined as GOP and GPT values three times higher than normal value - Patients who has Vitamin K deficiency - Female patients who is currently pregnant |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsiung Medical University | Kaohsiung | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | Chang Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Academia Sinica, Taiwan | Chang Gung Memorial Hospital, China Medical University Hospital, Kaohsiung Medical University |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time spent in target INR range | time spent in target INR range Time in the target INR Range will be the primary endpoints because of its strong association with adverse events: patients with subtherapeutic INR values are at increased risk of thrombosis and patients with high INR values are at increased risk of hemorrhage during warfarin treatment initiation. | first month of therapy | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|