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Chinese low intensity anticoagulant theray after heart valve replacement multi-center clinical study

Chinese low intensity anticoagulant theray after heart valve replacement multi-center clinical study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OCH-10001185
Enrollment
Unknown
Registered
2010-10-11
Start date
2011-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Valvular heart disease

Interventions

High-intensity group:INR=1.8-2.5
Low-intensity group:INR=1.5-2.0

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. From January 1st, 2011 to December 31st, 2012, the patients who need heart valve replacement surgery and postoperative anticoagulation therapy by oral administration of warfarin and accept INR as the index to assess the safety and efficacy of anticoagulation therapy are included; 2. The patients without the history of hemorrhage diseases; 3. The patients with normal, at least near to normal hepatic and renal function. / The patients without the severe hepatic and renal dysfunction; 4. During the period of postoperative anticoagulation, the participants are forbidden for non-steroid anti-inflammation drugs and other drugs which could affect the body's coagulation function except for the participants who have heart valve replacement surgery and coronary artery bypass graft surgery simultaneously or in turn and also need anti-platelet drugs; 5. The patients and their guardians agree to participate in the research programs and sign the informed consent; 6. The patients with good compliance and can be contacted easily in order to complete the follow-up.

Exclusion criteria

Exclusion criteria: 1. The participants who cannot follow the doctor's order and take warfarin regularly. 2. The data of the follow-up is incomplete. The frequency for monitoring INR: In the first month after surgery, once a week; In the second and third months after surgery, once two week; In the fourth to sixth months after surgery, once a month; After postoperative half year, if the effect of anticoagulation therapy is stable, the frequency of monitoring INR can be controlled every three months. But in some regions of lack of medical facilities for monitoring INR, the frequency can be prolonged to every half year.

Design outcomes

Primary

MeasureTime frame
International standard ratio (INR);

Countries

China

Contacts

Public Contactshiyingkang
syk@mcwcums.com+86 18980601001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 7, 2026