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Trial record 21 of 390 for:    Expanded Access Studies

Rivaroxaban in Mechanical Valves: RIMV Study (RIMV)

Expanded access is currently available for this treatment.
Verified September 2016 by Hospital Ana Nery
Sponsor:
Information provided by (Responsible Party):
Andre Duraes, PhD, Hospital Ana Nery
ClinicalTrials.gov Identifier:
NCT02894307
First received: September 5, 2016
Last updated: September 8, 2016
Last verified: September 2016
  Purpose
Anticoagulant treatment reduces the incidence of death and cardioembolic events in patients with atrial fibrillation or prosthetic heart valve and the incidence of death and recurrences in patients with VTE. Warfarin and similar vitamin K antagonists (VKA) have been the standard therapy for patients with a metallic valve, or bioprosthesis with atrial fibrillation (AF). The Dabigatran versus Warfarin in Patients with Mechanical Heart Valves (RE-ALIGN) trial comparing dabigatran etexilate to warfarin was the only randomized controlled study in patient with mechanical valve prosthesis, but it was terminated prematurely because of an excess of thromboembolic and bleeding events among patients in the dabigatran group. To date, novel oral anticoagulants (NOACs) have shown to be not both safe and or effective for patients with mechanical valves.

Condition Intervention
Thromboembolism
Drug: Rivaroxaban

Study Type: Expanded Access     What is Expanded Access?
Official Title: Evaluation of Thromboembolic Events in Patients With Bileaflet Mechanical Valves Before and After Rivaroxaban: RIMV Study

Resource links provided by NLM:


Further study details as provided by Hospital Ana Nery:

Intervention Details:
    Drug: Rivaroxaban
    In patients with mechanical valves and unstable INR
    Other Name: Xarelto 15 mg
Detailed Description:

Anticoagulant treatment reduces the incidence of death and cardioembolic events in patients with atrial fibrillation or prosthetic heart valve and the incidence of death and recurrences in patients with VTE.

Warfarin and similar vitamin K antagonists (VKA) have been the standard therapy for patients with a metallic valve, or bioprosthesis with atrial fibrillation (AF). Warfarin works by binding to vitamin K epoxide reductase to inhibit vitamin K-dependent coagulation factors II, VII, IX, and X. For all its extensive use, warfarin has many clinical shortcomings, including variable pharmacokinetic and pharmacodynamics properties, a narrow therapeutic index range, and numerous interactions with certain foods and drugs. All of these factors contribute to the need for frequent coagulation laboratory monitoring and dosage adjustments.

Even with the appropriate use of therapy, the incidence of thromboembolic events is still substantial: 1-4% per year. Furthermore, bleeding risk is significant, ranging from 2% to 9% per year. The VKA's narrow therapeutic index and they have a complex pharmacology, e.g. long pharmacologic inertia and the common interaction with other drugs. These features make the management of these drugs a challenge for physicians and their patients.

The Dabigatran versus Warfarin in Patients with Mechanical Heart Valves (RE-ALIGN) trial comparing dabigatran etexilate to warfarin was the only randomized controlled study in patient with mechanical valve prosthesis, but it was terminated prematurely because of an excess of thromboembolic and bleeding events among patients in the dabigatran group. Most thromboembolic events among patients in the dabigatran group occurred in population A (patients who had started a study drug within 7 days after valve surgery), with fewer occurring in population B (patients who had undergone valve implantation more than 3 months before randomization). Besides, stroke, death and major bleeding occurred only in population A. In this study, rivaroxaban will be used in patients with mechanical valves and unstable INR in a before and after designed.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Genders Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Age from 18 to 64 years at entry;
  • Patients with mitral and/or aorthic mechanical valve for at least 3 months postoperatively;
  • Brain computed tomography scan without hemorrhage or findings of acute cerebral infarction on the last 2 days of screening;
  • Exclusion of atrial thrombus or valve prosthesis thrombosis by transesophageal echocardiograph on the last 2 days of screening;
  • Written, informed consent;

Exclusion Criteria:

  • Previous hemorrhagic stroke;
  • Ischemic stroke in the last 6 months;
  • Renal impairment (creatinine clearance rates < 50 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 hypertension;
  • Gastrointestinal hemorrhage within the past year;
  • Anemia (hemoglobin level <10 g/dL) or thrombocytopenia (platelet count < 100 × 109/L);
  • Active infective endocarditis;
  • Pregnant or lactating women;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02894307

Contacts
Contact: Andre R Duraes, PhD +5571991888399 andreduraes@gmail.com
Contact: Coreme HAN +7131171903

Sponsors and Collaborators
Hospital Ana Nery
  More Information

Responsible Party: Andre Duraes, PhD, Andre Duraes, Hospital Ana Nery
ClinicalTrials.gov Identifier: NCT02894307     History of Changes
Other Study ID Numbers: 57506416.4.0000.0045 
Study First Received: September 5, 2016
Last Updated: September 8, 2016
Health Authority: Brazil: Ministry of Health

Keywords provided by Hospital Ana Nery:
MEchanical valves
Rivaroxaban

Additional relevant MeSH terms:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants

ClinicalTrials.gov processed this record on January 14, 2017