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临床试验/NCT06145269
NCT06145269尚未招募早期 1 期

Recanalization Rate of Acute Deep Venous Thrombosis Related to Therapeutic Modality- Comparative Study; New Oral Anticoagulants (NOACs) Vs. Conventional Treatment.

Assiut University0 个研究点目标入组 100 人开始时间: 2023年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
尚未招募
入组人数
100
主要终点
Recanalization rate of the thrombosed vein with the two comparable groups.

研究概览

简要总结

Rporting and evaluation of the rate of recanalization of acute DVT of the lower limb at one year follow-up comparing the results of using NOACs vs. conventional treatment.

详细描述

Deep vein thrombosis (DVT) is an important cause of disability and mortality in our society . The incidence of DVT significantly increases with age, being more prevalent in women than men . The location of DVT is also an important factor to be studied because of its association with pulmonary embolism and development of post-thrombotic syndrome (PTS) , Currently, duplex ultrasound scanning (DUS) is the method of choice for diagnosis of DVT because it is non-invasive, provides real-time imaging, and has high sensitivity and specificity especially for detection of proximal DVT .

The new oral anticoagulants (NOACs), are poised to replace warfarin for treatment of the majority of patients with venous thromboembolism (VTE), With a rapid onset of action and the capacity to be administered in fixed doses without routine coagulation monitoring, NOACs have been shown to be noninferior to conventional anticoagulant therapy for prevention of recurrence with less bleeding.

Most studies have reported that more advantages than disadvantages for NOACs when compared with VKAs, with the most important advantages of NOACs including safety issues (ie, a lower incidence of major bleeding), convenience of use, minor drug and food interactions, a wide therapeutic window, and no need for laboratory monitoring. Nonetheless, there are some conditions for which VKAs remain the drug of choice.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients suffering from first attack of acute DVT (De novo) of the lower limb who (only femoral-popliteal type) aged 18 - 80 years.

排除标准

  • Patients suffering from recurrent DVT.
  • Patients with acute DVT candidate for CDT (limb threatening acute DVT).
  • Patients suffering from acute DVT with malignancy.
  • Pregnant and Lactating females.
  • Patients with severe renal Impairment (CrCl <30mL/min), Severe hepatic impairment.

研究组 & 干预措施

New oral anticoagulant (rivaroxaban)

Active Comparator

We will use (rivaroxaban) 15 mg oral tablets twice a day, After 21 days: Should transition to 20 mg orally once a day untill we complete 6 months from the starting the treatment.

干预措施: New oral anticoagulant (rivaroxaban) and Marevan (warfarin) (Drug)

Marevan (warfarin)

Active Comparator

Initiate warfarin on day 1 or 2 of parenteral anticoagulation therapy (eg, LMWH or unfractionated heparin) Overlap warfarin and parenteral anticoagulant for at least 5 days until desired INR (>2.0) maintained for 24 hours, then discontinue parenteral therapy and continue only with (warfarin) tablets 5 mg/day for 6 months.

干预措施: New oral anticoagulant (rivaroxaban) and Marevan (warfarin) (Drug)

结局指标

主要结局

Recanalization rate of the thrombosed vein with the two comparable groups.

时间窗: baseline

Reporting and evaluation the rate of recanalization of acute DVT of the lower limb at one year follow-up comparing the results of using NOACs vs. conventional treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Mahmoud Yaseen

Assistant Lecturer

Assiut University

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