Prosthesis; Cardiac, Heart, Functional Disturbance as ResultRMVNCT02894307
Rivaroxaban in Mechanical Valves: RMV Study
A study testing Rivaroxaban in people with Prosthesis; Cardiac, Heart, Functional Disturbance as Result, run by Hospital Ana Nery.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Prosthesis; Cardiac, Heart, Functional Disturbance as Result
- What is being tested?
- Rivaroxaban
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Adult
Who may be able to join
- Age from 18 to 64 years at entry;
- Patients with mitral 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;
Who cannot join
- 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);
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- 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;
About this study
Official title: Evaluation of Thromboembolic Events in Patients With Bileaflet Mechanical Valves in Mitral Position Before and After Rivaroxaban Use: RMV Study
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.
Read the 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.
- Being tested
- Rivaroxaban
- Keywords
- Mechanical prosthesis, Rivaroxaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Xarelto 15 mg
In patients with mechanical valves and unstable INR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prosthesis; Cardiac, Heart, Functional Disturbance as ResultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Hospital Ana Nery
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Bahia
- Responsible party
- Principal investigator, Andre Duraes, MD, PhD, Hospital Ana Nery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894307
- Sponsor's protocol ID
- 69327617.7.0000.5028
- Acronym
- RMV
- Status last verified
- Mar 2018
- First submitted
- 5 Sep 2016
- Last updated
- 13 Mar 2018
- Results posted
- No
Publications
Duraes AR, de Souza Roriz P, de Almeida Nunes B, Albuquerque FP, de Bulhoes FV, de Souza Fernandes AM, Aras R. Dabigatran Versus Warfarin After Bioprosthesis Valve Replacement for the Management of Atrial Fibrillation Postoperatively: DAWA Pilot Study. Drugs R D. 2016 Jun;16(2):149-54. doi: 10.1007/s40268-016-0124-1.
PubMed 26892845Duraes AR, Bitar YSL, Lima MLG, Santos CC, Schonhofen IS, Filho JAL, Roever L. Usefulness and Safety of Rivaroxaban in Patients Following Isolated Mitral Valve Replacement With a Mechanical Prosthesis. Am J Cardiol. 2018 Sep 15;122(6):1047-1050. doi: 10.1016/j.amjcard.2018.06.015. Epub 2018 Aug 8.
PubMed 30098707
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thromboembolic Events in Patients With Bileaflet Mechanical Valves in Mitral Position Before and After Rivaroxaban Use: RMV Study
- ClinicalTrials.gov ID
- NCT02894307
- Acronym / sponsor ID
- RMV / 69327617.7.0000.5028
- Keywords
- Mechanical prosthesis, Rivaroxaban
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Hospital Ana NeryUniversity, hospital or other
- Collaborators
- Federal University of Bahia
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age from 18 to 64 years at entry;
- Patients with mitral 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;
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanAlso: Xarelto 15 mgIn patients with mechanical valves and unstable INR | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Results publication: PubMed 26892845Duraes AR, de Souza Roriz P, de Almeida Nunes B, Albuquerque FP, de Bulhoes FV, de Souza Fernandes AM, Aras R. Dabigatran Versus Warfarin After Bioprosthesis Valve Replacement for the Management of Atrial Fibrillation Postoperatively: DAWA Pilot Study. Drugs R D. 2016 Jun;16(2):149-54. doi: 10.1007/s40268-016-0124-1.
- Derived from this study: PubMed 30098707Duraes AR, Bitar YSL, Lima MLG, Santos CC, Schonhofen IS, Filho JAL, Roever L. Usefulness and Safety of Rivaroxaban in Patients Following Isolated Mitral Valve Replacement With a Mechanical Prosthesis. Am J Cardiol. 2018 Sep 15;122(6):1047-1050. doi: 10.1016/j.amjcard.2018.06.015. Epub 2018 Aug 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rivaroxaban in people with Prosthesis; Cardiac, Heart, Functional Disturbance as Result, run by Hospital Ana Nery.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02894307, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.