The effect of efficacy and safety of Individual anticoagulation therapy of warfarin in patients with mechanical valve replacement: a randomized controlled trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000041309

Enrollment

Unknown

Registered

2020-12-23

Start date

2020-01-01

Completion date

Unknown

Last updated

2021-03-08

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

Conditions

Mechanical prosthetic heat valves

Interventions

experimental group:Gene guided drug taken

control group:Traditional drug taken

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old; 2. Patients who signed informed consent voluntarily; 3. Patients who plan to undergo mechanical valve replacement surgery; 4. Patients taking warfarin for the first time.

Exclusion criteria

Exclusion criteria: 1. Patients who are taking warfarin or have taken warfarin within 6 months; 2. Patients with abnormal INR ( 1.2) before operation; 3. Patients whose genotypes cannot be detected; 4. Patients with life expectancy less than 6 months; 5. Pregnant or lactating women; 6. Patients with untreated or uncontrollable hypertension (the combination of three antihypertensive drugs can not effectively reduce blood pressure); 7. The patients with elevated transaminase were more than 3 times of the upper limit, bilirubin was more than the upper limit, severe liver function damage (Child C grade), liver cirrhosis; 8. Patients with history of gastrointestinal bleeding, gastrointestinal diverticulosis or gastrointestinal tumor; 9. Alcoholics (drinking 5 or more bottles of beer at one time or alcohol content in human blood reaches or exceeds 0.08g/dl); 10. Patients with dementia, psychosis and other conditions unable to follow the dose instructions for anticoagulant treatment; 11. Patients with hematological diseases (Willebrand's disease, hemophilia, thrombocytopenia and thrombocytopenia); 12. Patients with other cardiac operations (except maze operation); 13. Patients with infective endocarditis and pericarditis; 14. Subjects who participated in clinical trials of other drugs within 6 months.

Design outcomes

Primary

Measure	Time frame
Percent of time in therapeutic range (PTTR) in 6 months;	—

Secondary

Measure	Time frame
Fraction of time in therapeutic range (FTTR) in 6 months;Time to first reach target INR;Time to reach stable dose;Ratio of international normalized ratio (INR);Severe bleeding;New thrombosis;	—

Countries

China

Contacts

Public ContactDong Ran

Beijing Anzhen Hospital Affiliated to Capital Medical University

dongran6618@hotmail.com+86 13810117710

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026