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Trial record 43 of 235 for:    warfarin AND International

Social-software iMproving wARfarin Therapy (SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03264937
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Litao Zhang, MD, Wuhan Asia Heart Hospital

Tracking Information
First Submitted Date  ICMJE August 22, 2017
First Posted Date  ICMJE August 29, 2017
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE September 1, 2017
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
Time to First Event [ Time Frame: Up to 18 months ]
Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage,gastrointestinal bleeding etc.
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2017)
  • Thrombotic events [ Time Frame: 24 months ]
    Stroke,TIA,Peripheral vascular embolization,Transient ischemic attack etc.
  • Major bleeding events [ Time Frame: 24 months ]
    cerebral hemorrhage,gastrointestinal bleeding etc.
  • Deaths [ Time Frame: 24 months ]
    All-cause deaths
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Time in therapeutic range [ Time Frame: Up to 18 months ]
    Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio
  • Individual variation of International Normalized Ratio (INR) [ Time Frame: Up to 18 months ]
    Standard deviation (SD) of individual INR results
  • Times of extremely high International Normalized Ratio (INR) values [ Time Frame: Up to 18 months ]
    Times of INR results above 4.0; Times of INR results above 12.0
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2017)
Time in therapeutic range [ Time Frame: 24 months ]
Time in therapeutic range of international normalized ratio
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Social-software iMproving wARfarin Therapy
Official Title  ICMJE Randomized Evaluation of Social-software Improving Warfarin Therapy in Patients With Mechanical Heart Valve Replacement
Brief Summary Poor anticoagulation quality is a major problem among Chinese patients receiving warfarin therapy in traditional health care settings. Improving warfarin therapy has been crucial for Chinese patients. Wechat is social-software in China. Most of all Chinese adults use Wechat, as well as our patients. So we set up a Wechat-based mini-program to instruct Chinese patients' warfarin therapy. We aim to assess whether social software could improve warfarin therapy in Chinese patients by conducting a single-centre, open-label, prospective, randomized clinical trial.
Detailed Description

Social software is becoming a necessary of life. Wechat, powered by Tencent company, is the most popular social software in China. People can chat with others no matter how far away from each other.

Anticoagulation Quality is very important for patients receiving warfarin anticoagulation therapy, which is usually evaluated Time in therapeutic range (TTR). It is reported that TTR is very low (38.8%) in China patients. So we are planning to introduce the social software to set up a bridge for clinicians and their patients, to instruct warfarin therapy. We aim to investigate whether social software could be used to improve warfarin anticoagulation quality of Chinese patients.

We planned to enrol enough eligible patients receiving warfarin therapy due to the mechanical valves in a randomized controlled trial. Warfarin-treated patients were assigned to social software management group ( in which warfarin therapy was guided via the social platform by experienced clinicians) or to the traditional management control group (in which warfarin therapy was managed with traditional model). The primary outcomes the first time to bleeding or thrombotic events, the secondary outcomes were an elevation in time in therapeutic range (TTR) of international normalized ratio (INR), reduction in INR variation and number of extremely high INR results during 18 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anticoagulants Causing Adverse Effects in Therapeutic Use
  • Patient Compliance
Intervention  ICMJE Behavioral: Social-software management
Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.
Study Arms  ICMJE
  • Experimental: Social-software management group
    We set up a mini-program based on wechat application. We instruct warfarin therapy via social-software including dose adjustment, answer questions, remind monitoring INR et.al.
    Intervention: Behavioral: Social-software management
  • No Intervention: Routine management group
    This is the control group, Warfarin therapy was managed via traditional style without social software intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2019)
735
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2017)
400
Actual Study Completion Date  ICMJE March 8, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Received mechanical valve replacement;
  • Receiving warfarin anticoagulation therapy;
  • Have smartphone and Know how to use wechat application and our mini-program;
  • be expected to survive for the duration of the study;
  • not be suffering from intracranial bleeding (intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke) or any other contraindication described in the warfarin package insert;
  • be willing to be randomized;
  • sign the informed consent form;
  • not be enrolled in another randomized clinical trial that involves a drug or device intervention.

Exclusion Criteria:

  • subject has had an intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
  • subject enrolled in another randomized clinical trial that involves a drug or device intervention
  • subject is not able to follow the protocol and all related instructions and does not have a caregiver with these skills
  • Patients were considered being not suitable for this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03264937
Other Study ID Numbers  ICMJE 2017-P-033
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We are going to make individual participant data (IPD) available to other researchers after our paper published
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Litao Zhang, MD, Wuhan Asia Heart Hospital
Study Sponsor  ICMJE Wuhan Asia Heart Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Zhenlu Zhang, MD,PhD Wuhan Asia Heart Hospital
PRS Account Wuhan Asia Heart Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP