Recanalization Rate of Acute DVT

NCT06145269 | Unknown Early Phase 1

• 1 other identifier: Recanalization rate(acute DVT)
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute DVT of Lower Extremity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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

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.

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

Interventions

New oral anticoagulant (rivaroxaban) and Marevan (warfarin) DRUG

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

Marevan (warfarin); New oral anticoagulant (rivaroxaban)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Links

• INCIDENCE OF DEEP VENOUS THROMBOSIS IN STROKE PATIENTS IN MEDICAL INTENSIVE CARE UNIT ZAGAZIG UNIVERSITY HOSPITALS, EGYPT

MeSH Terms

Interventions

Rivaroxaban; Warfarin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Amr Yaseen, bachelor

CONTACT

01020398137; amryaseen1996@gmail.com

Mohamed Mobarak, MD

CONTACT

+20 122 477 6197; mmubarak990@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 24, 2023
• Study Start: December 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11