Recanalization Rate of Acute DVT

Assiut University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Acute DVT of Lower Extremity

Treatments: Drug: New oral anticoagulant (rivaroxaban) and Marevan (warfarin)

Study type: Interventional

Funder types: Other

Identifiers

NCT06145269

Recanalization rate(acute DVT)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

New oral anticoagulant (rivaroxaban)

Active Comparator group

Description:

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.

Treatment:

Drug: New oral anticoagulant (rivaroxaban) and Marevan (warfarin)

Marevan (warfarin)

Active Comparator group

Description:

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.

Treatment:

Drug: New oral anticoagulant (rivaroxaban) and Marevan (warfarin)