Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves
报名条件（概要）
- 年龄：18 Years – 45 Years
- 性别：女性
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
Canada
药品与企业信息
1\) Therapeutic LMWH throughout pregnancy either using weight-based dosing or dosing according to anti-Xa levels. The initial dose will be a twice daily therapeutic dose of 1.35U/kg (pregnancy weight) of enoxaparin or 135 U/kg (pregnancy weight) of dalteparin using prefilled syringes titrated to the higher dose prefilled syringe (i.e., not below the pregnancy weight-based dosing). 1. The dose of therapeutic LMWH can be adjusted by anti-Xa (done at least after four days of the start of LMWH or change in LMWH dose) levels or by pregnancy weight however, weight and anti-Xa levels will be determined for all participants using LMWH. Pregnancy weight in kilograms is to be determined every month. 2. If therapeutic LMWH is adjusted according to anti-Xa levels, peak and trough anti-Xa levels (done at least after four days of the start of LMWH or change in LMWH dose) are to be sent every four weeks or weekly if there is a change in dose.
VKAs during pregnancy: VKA use will require INRs every two weeks or weekly (done at least 5 days after starting or changing the dose) if there is a change in doses to ensure an INR of 2.5 for a patient with an aortic MVR (INR of 2 for the On-X AVR) and 3 for mitral MVR or two MHVs is met. LDA 81 mg to be added once pregnancy is confirmed.
其他名称：LMWH、Vitamin K antagonist、warfarin
LMWH at 6 weeks gestation until 12 weeks gestation prescribed according to the regimens above then VKAs from 12 weeks gestation until 34-36 weeks gestation followed by twice daily LMWH according to doses above until delivery. LDA to be added when pregnancy is confirmed
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
The purpose of this pilot study is to collect data on pregnancies with mechanical heart valves to see if using a blood thinner called low molecular weight heparin (LMWH) and low dose aspirin (LDA) is comparable to warfarin/vitamin K antagonist (VKA) to reduce the chance of clotting around the mechanical valve and improve survival. The study is a pilot study as the study investigators need to ensure that the blood levels needed for adequate amounts of LMWH and warfarin can be maintained during pregnancy to be able to compare LMWH and aspirin to warfarin. If this study shows that we can collect the tests that are needed for a larger study, the individuals' information who participated in this pilot study will be moved to the larger study. The larger study will compare survival, clot development and cardiac function as well as safety of these two common blood thinners.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人（申办方／研究总部）
- Nadine Shehata, MDnadine.shehata@sinaihealth.ca4165865133
研究中心联系方式
- Mount Sinai HospitalToronto，Ontario，Canada
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves ClinicalTrials.gov Identifier: NCT07658989 Sponsor: Mount Sinai Hospital, Canada Investigational product: LMWH and LDA, Vitamin K antagonists (e.g warfarin)+/- LDA, Sequential therapy +/- LDA About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves 试验编号：NCT07658989 申办方：Mount Sinai Hospital, Canada 研究药物：LMWH and LDA、Vitamin K antagonists (e.g warfarin)+/- LDA、Sequential therapy +/- LDA 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。