Rivaroxaban Plus Aspirin to Manage Recurrent Venous Thromboembolic Events

NCT05515120 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 000001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

venous thromboembolism; Rivaroxaban; Aspirin; Acenocoumarol

Outcome Measures

Primary Outcomes (1)

• Efficacy outcome The presence of thromboembolic events

  Recurrent ipsilateral Deep vein thrombosis, Recurrent contralateral Deep vein thrombosis, Pulmonary emboli, Ischemic stroke and Myocardial infarction

  90 days

Secondary Outcomes (1)

• Major or clinically relevant nonmajor bleeding

  90 days

Study Arms (2)

Rivaroxaban plus Aspirin

ACTIVE COMPARATOR

Drug: Rivaroxaban 15 mg Rivaroxaban 15 mg BID Other Names: Xarelto 15 mg Rivaroxabana 15 mg Drug: Aspirin 300 mg

Drug: Rivaroxaban 20 MG [Xarelto]; Drug: Aspirin 300mg

Acenocoumarol

PLACEBO COMPARATOR

Drug: Acenocoumarol Other Name: Vitamin K antagonist

Drug: Acenocoumarol Oral Tablet

Interventions

Rivaroxaban 20 MG [Xarelto] DRUG

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

Also known as: Xarelto 20 mg

Rivaroxaban plus Aspirin

Aspirin 300mg DRUG

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

Also known as: Acetilsalicilic acid

Rivaroxaban plus Aspirin

Acenocoumarol Oral Tablet DRUG

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

Also known as: Vitamin K antagonist

Acenocoumarol

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Objectively proven first episode of venous thromboembolism (upper extremity deep vein thrombosis, proximal lower extremity deep vein thrombosis, or pulmonary embolism).
• Objectively documented recurrent venous thromboembolism (either new or extended upper extremity deep vein thrombosis, proximal lower extremity deep vein thrombosis or pulmonary embolism) while taking systemic anticoagulation medication (Rivaroxaban).

You may not qualify if:

• Previous hemorrhagic stroke Ischemic stroke in the last 3 months Severe renal impairment (CrCl rates \< 30 ml/min) Active liver disease (any etiology) Concomitant use of any antiplatelet (aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine, etc.) Increased risk of bleeding (congenital or acquired) Uncontrolled SAH Gastrointestinal hemorrhage within the past year Anemia (Hb level \< 10 g/dl) or thrombocytopenia (platelet count \< 100 × 109/l) Pregnant or lactating women

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Instituto Mexicano Del Seguro Social

Metepec, State of Mexico, 55056, Mexico

Location

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Interventions

Rivaroxaban; Aspirin; Acenocoumarol; acarboxyprothrombin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 25, 2022
• Study Start: January 3, 2021
• Primary Completion: January 9, 2022
• Study Completion: July 1, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)