Rivaroxaban vs Warfarin in Patients With Metallic Prosthesis

NCT03566303 | Terminated Phase 2 DMC

• 1 other identifier: 90288318.0.0000.5028
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical heart valves (MHV) demand lifelong anticoagulation with vitamin K antagonists (VKA) due to the high thrombogenicity of the prosthesis. Rivaroxaban has previously been tested in experimental and animal models with encouraging results. The investigators recently sent for publication an experiment with 7 patients who used rivaroxaban in metallic prosthesis with encouraging results. In this way it was decided to do a randomized non-inferiority clinical trial comparing rivaroxaban with warfarin in patients with metallic prosthesis.

Conditions

Prostheses and Implants; Stroke; Valve Heart Disease; Anticoagulants and Bleeding Disorders

Keywords

Valve Heart Disease; Rivaroxaban; Warfarin

Outcome Measures

Primary Outcomes (2)

• Patients with thromboembolic events: Stroke, transient ischemic attack (TIA), silent brain infarction (SBI) and systemic embolism (SE).

  The primary endpoint was defined as stroke, TIA, SBI and systemic embolism

  90 days

• major or clinically relevant nonmajor bleeding

  The primary safety outcome was major or clinically relevant nonmajor bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria and Bleeding Academic Research Consortium (BARC)

  90 days

Secondary Outcomes (4)

• Patients with e of stroke/TIA/SBI/SE and/or death from any cause.

  90 days

• Cases of myocardial infarction during of follow-up

  90 days

• New cases of valve thrombosis with or without symptoms

  90 days

• New intracardiac thrombus detected at the end of clinical follow-up by transesophageal echocardiogram

  90 days

Other Outcomes (1)

• Cases of minor bleeding

  90 days

Study Arms (2)

Rivaroxaban

ACTIVE COMPARATOR

Rivaroxaban 15mg BID

Drug: Rivaroxaban 15 mg

Warfarin

PLACEBO COMPARATOR

Warfarin dose adjusted

Drug: Warfarin

Interventions

Rivaroxaban 15 mg DRUG

Rivaroxaban 15 mg BID

Also known as: Xarelto 15 mg, Rivaroxabana 15 mg

Rivaroxaban

Warfarin DRUG

Warfarin

Also known as: Vitamin K antagonist

Warfarin

Eligibility Criteria

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

You may qualify if:

• \- Mechanical prosthetic valve replacement after at least 3 months postoperative

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)
• Active infective endocarditis
• Pregnant or lactating women

Sponsors & Collaborators

• Hospital Geral Roberto Santos: lead

Study Sites (1)

Andre Duraes

Salvador, Estado de Bahia, 41815000, Brazil

Location

Related Publications (2)

• Duraes AR, de Souza Lima Bitar Y, Schonhofen IS, Travassos KSO, Pereira LV, Filho JAL, Neto MG, Junior RA, Roever L. Rivaroxaban Versus Warfarin in Patients with Mechanical Heart Valves: Open-Label, Proof-of-Concept trial-The RIWA study. Am J Cardiovasc Drugs. 2021 May;21(3):363-371. doi: 10.1007/s40256-020-00449-3. Epub 2020 Nov 5.

  PMID: 33150497 DERIVED

• Duraes AR, de Souza Lima Bitar Y, Filho JAL, Schonhofen IS, Camara EJN, Roever L, Cardoso HEDP, Akrami KM. Rivaroxaban versus Warfarin in Patients with Mechanical Heart Valve: Rationale and Design of the RIWA Study. Drugs R D. 2018 Dec;18(4):303-308. doi: 10.1007/s40268-018-0249-5.

  PMID: 30293126 DERIVED

MeSH Terms

Conditions

Stroke; Heart Valve Diseases; Hemostatic Disorders

Interventions

Rivaroxaban; Warfarin; acarboxyprothrombin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

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

Study Officials

• Andre Duraes, PhD

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 25, 2018
• Study Start: July 10, 2018
• Primary Completion: April 26, 2020
• Study Completion: April 26, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)