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Recanalization Rate of Acute DVT

NCT ID: NCT06145269

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-06-01

Brief Summary

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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

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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.

Conditions

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Acute DVT of Lower Extremity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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New oral anticoagulant (rivaroxaban)

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.

Group Type ACTIVE_COMPARATOR

New oral anticoagulant (rivaroxaban) and Marevan (warfarin)

Intervention Type DRUG

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

Marevan (warfarin)

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.

Group Type ACTIVE_COMPARATOR

New oral anticoagulant (rivaroxaban) and Marevan (warfarin)

Intervention Type DRUG

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

Interventions

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New oral anticoagulant (rivaroxaban) and Marevan (warfarin)

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amr Mahmoud Yaseen

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Amr Yaseen, bachelor

Role: CONTACT

[email protected]
01020398137 ext. +2

Mohamed Mobarak, MD

Role: CONTACT

[email protected]
+20 122 477 6197 ext. +2

Related Links

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http://zumj.journals.ekb.eg/article_4349_5855d1034c50f928ccadc9384e6d656c.pdf

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

Other Identifiers

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Recanalization rate(acute DVT)

Identifier Type: -

Identifier Source: org_study_id