Academic Leader，Head of Cardiac Surgery,Principal Investigator, Clinical Professor
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- time to steady dosage
研究概览
简要总结
Until very recently, warfarin is still the best drug of choice for long-term anticoagulation for patients with mechanical prosthetic heart valve. However, the complication of warfarin account for 75 percent of the whole complication after the mechanical prosthetic heart valve replacement.
Interindividual variation in warfarin dose is mediated by multiple factors.Advanced models using combinations of clinical attributes and genetic factors(CYP2C9, VKORC1, and CYP4F2) explain 50-75% of variability in warfarin dose requirements.These warfarin dosing models have the potential to improve patient safety by reducing or eliminating serious adverse events. The investigators conducted a prospective, randomized, blinded, two arm trial to test this hypothesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the first time to receive elective mitral and/or aortic mechanical prosthetic valve replacement
- •willing to join in the clinical trial and comply with the protocol.
排除标准
- •other ethnic groups than Han
- •previously receive any other cardiac surgery
- •emergent surgery
- •simultaneously carry out other cardiac surgeries,such as CABG
- •age younger than 18y or older than 65 year
- •drug abuser and wine abuser
- •any malignancy
- •moderate or severe hepatic or kidney insufficiency
- •any thyroid disease
- •the history of warfarin or VitK consumption 2 week before the surgery
- •any hematological disease or history of bleeding
- •combination with any drugs that significantly influence warfarin other than Cordarone
- •pregnancy
- •any contraindication of warfarin
- •infectious endocarditis
- •advanced valvular disease
- •pathological obesity
- •psychological disease
- •any patient having joined in other clinical trial in the previous 30d
- •basic INR > 1.4
结局指标
主要结局
time to steady dosage
时间窗: from seven days after the operation to thirty days after the operation
Time in Therapeutic Range
时间窗: from five days after the operation to thirty days after the operation
次要结局
- first time to treatment window(from five days after the operation to thirty days after the operation)
- the ratio of INR≥3.0 and INR≤1.5(from five days after the operation to thirty days after the operation)
- absolute difference between the stable dose and initial dose(30 days after the operation)
- the frequency of dosage change(30 days after the operation)
- the whole-cause mortality(30 days after the operation)
- major thrombosis rate(30 days after the operation)
- the monitoring frequency of INR(30 days after the operation)
- major bleeding event(30 days after the operation)
研究者
Xi Zhang
Head of cardiac surgery
First Affiliated Hospital, Sun Yat-Sen University