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Rivaroxaban Plus Aspirin to Manage Recurrent Venous Thromboembolic Events

NCT05515120 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-08-25

No results posted yet for this study

Summary

Venous thromboembolism affects around 10 million people per year worldwide, however, despite its high incidence, there is no systematic review or randomized trial focused on the treatment of patients with recurrent deep vein thrombosis (DVT) and/or or pulmonary embolism (PE) during anticoagulant treatment. The objective was to compare the use of Rivaroxaban plus Aspirin versus Acenocoumarol in patients with recurrent venous thromboembolism treated with rivaroxaban.

Conditions

  • Venous Thromboembolism
  • Anticoagulant-induced Bleeding
  • Venous Thromboses
  • Pulmonary Embolism

Interventions

DRUG

Rivaroxaban 20 MG [Xarelto]

It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization)

DRUG

Aspirin 300mg

It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization)

DRUG

Acenocoumarol Oral Tablet

It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization)

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-03
Primary Completion
2022-01-09
Completion
2022-07-01
FDA Drug
Yes

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05515120 on ClinicalTrials.gov