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Recanalization Rate of Acute DVT

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06145269
Enrollment
100
Registered
2023-11-24
Start date
2023-12-01
Completion date
2025-06-01
Last updated
2023-11-24

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

Conditions

Acute DVT of Lower Extremity

Brief 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.

Detailed 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.

Interventions

DRUGNew oral anticoagulant (rivaroxaban) and Marevan (warfarin)

comparison between 2 drug, (rivaroxaban) and Marevan (warfarin)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recanalization rate of the thrombosed vein with the two comparable groups.baselineReporting 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.

Contacts

Primary ContactAmr Yaseen, bachelor
amryaseen1996@gmail.com01020398137
Backup ContactMohamed Mobarak, MD
mmubarak990@gmail.com+20 122 477 6197

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026