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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06145269
Other study ID # Recanalization rate(acute DVT)
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date December 1, 2023
Est. completion date June 1, 2025

Study information

Verified date November 2023
Source Assiut University
Contact Amr Yaseen, bachelor
Phone 01020398137
Email amryaseen1996@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 1, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - • Patients suffering from first attack of acute DVT (De novo) of the lower limb who (only femoral-popliteal type) aged 18 - 80 years. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
New oral anticoagulant (rivaroxaban) and Marevan (warfarin)
comparison between 2 drug, (rivaroxaban) and Marevan (warfarin)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Recanalization rate of the thrombosed vein with the two comparable groups. 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. baseline
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03575364 - ClotTriever Outcomes (CLOUT) Registry
Terminated NCT03465735 - Vascular Boot Warming Program After Acute Deep Vein Thrombosis (DVT) ± Pulmonary Embolism (PE) N/A
Recruiting NCT06446024 - Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan