Clinical TrialID 2386

Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis

NCT03413618

Deep Vein Thrombosis|Postthrombotic Syndrome

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
2386
Evidence Id
2386
Core Evidence Id
2386
Source Clinical Trial Id
2363
Herb2 Clinical Trial Id
HBCT002363
Nct Id
NCT03413618
Title
Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis
Status
Completed
Phase
Phase 4
Study Result
Yes
Study Condition
Deep Vein Thrombosis|Postthrombotic Syndrome
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Rivaroxaban|DRUG: Diosmin|OTHER: compression stockings
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Single
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
90
Outcome Measure
Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score, Detection of the postthrombotic syndrome (PTS) was made according to the Villalta score (a combination of 5 subjective symptoms and 6 objective signs of chronic venous disease) ranged from 0 (no signs) to 33 scores (maximal severity). PTS defined as 5 and more scores; mild PTS as 5-9 scores; moderate PTS as 10-14 scores; severe PTS as 15 and more scores., 12 months
Sponsor Collaborator
Pirogov Russian National Research Medical University
Funded By
OTHER
Location
Clinical Hospital no.1 of the President's Administration of Russian Federation, Moscow, 121352, Russian Federation
Other Id
RIDILOTT-DVT
Start Date
2017-12-20
Primary Completion Date
2019-07-31
Completion Date
2019-07-31
First Posted
2018-01-29
Results First Posted
2020-01-27
Last Update Posted
2021-02-04
Study Document
Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/18/NCT03413618/Prot_SAP_000.pdf
Study Url
https://clinicaltrials.gov/study/NCT03413618
Title Cn
Title En
Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis
Bilingual Status
semi_complete