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A study to assess the safety and efficacy of self-management models of warfarin and to explore patient preferences for different management models

A study to assess the safety and efficacy of self-management models of warfarin and to explore patient preferences for different management models

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091337
Enrollment
Unknown
Registered
2024-10-26
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart disease

Interventions

Self-management (experimental group):Require self-monitoring of INR at home every 1-2 weeks, self-adjustment of medication, and uploading of records to the remote anticoagulation follow-up platform
usual care group (control group):No intervention, regular doctor's visits

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Control patients: 1) Previously enrolled in the SMART study and will continue to be treated with warfarin for the next 12 months and will continue to have their INR reviewed in the outpatient clinic; 2) TTR > 45% in the previous year; 3) Compliance with the study protocol; 4) signing the informed consent form. Patients in the experimental group: 1) Previously participated in the PST group of the SMART study and will continue to take warfarin for treatment in the next 12 months, participated in the training related to self-management and passed the relevant examination, and will be engaged in warfarin self-management; 2) TTR > 45% in the previous year; 3) Obedience to the study protocol; 4) signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1) is pregnant or has plans to become pregnant in the next 6 months; 2) hospitalisation for a major bleeding or embolic adverse event in the past 6 months 3) advanced renal failure (on haemodialysis or with glomerular clearance <10mL/min); 4) Alzheimer's disease or schizophrenia; 5) undergoing anti-cancer treatment; 6) has congestive heart failure and requires medication; 7) a history of bleeding, such as gastric ulcers 8) concurrently taking antiplatelet drugs such as aspirin. 9) Previous TTR=45%.

Design outcomes

Primary

MeasureTime frame
time in therapeutic range (TTR);

Secondary

MeasureTime frame
serious adverse events;

Countries

China

Contacts

Public ContactShenglan Tan

The Second Xiangya Hospital of Central South University

94794635@qq.com+86 134 6758 9877

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 26, 2026