Mitral Valve Stenosis and InsufficiencyPhase 4NCT03183843
Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses
A Phase 4 study testing Dabigatran Etexilate and Warfarin in people with Mitral Valve Stenosis and Insufficiency and Atrial Fibrillation, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia at 1 site in Russia.
Trial summary
The efficacy and safety of anticoagulation therapy using dabigatran in comparison with warfarin will be evaluated in patients with atrial fibrillation after mitral valve prosthetic replacement concomitant with Cox-Maze procedure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mitral Valve Stenosis and Insufficiency, Atrial Fibrillation
- What is being tested?
- Dabigatran Etexilate and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 29 Jun 2016to 1 Dec 2018
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mitral valve disease;
- atrial fibrillation;
- mitral valve prosthetic replacement with concomitant Cox-Maze Procedure;
- 18-75 years of age;
- signed informed consent form.
Who cannot join
- mechanical valve replacement;
- repeated mitral valve surgery;
- coronary artery hemodynamically significant stenoses;
- ventricular arrhythmias;
- creatinine clearance <50 ml/min;
- HAS-BLED score >3;
Show all 13Show fewer
- previous stroke or transient ischemic attack;
- liver diseases;
- neoplasia;
- pregnancy;
- simultaneous antiplatelet therapy;
- allergic reactions on Dabigatran or Warfarin;
- cognitive disorders.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Research Institute for Complex Problems of Cardiovascular Diseases
Kemerovo, 650061
About this study
Official title: The Use of Dabigatran Etexilate in Patients With Atrial Fibrillation After Mitral Valve Prosthetic Replacement
The efficacy and safety of anticoagulation therapy using dabigatran in comparison with warfarin will be evaluated in patients with atrial fibrillation after mitral valve prosthetic replacement concomitant with Cox-Maze procedure.
Read the detailed description
Patients with prosthetic mitral valves need a long-term anticoagulation therapy. After mitral valve replacement using mechanical prostheses warfarin is administrated during the whole life. Biological prostheses allows do discontinue anticoagulation 3 months after surgery in the absence of other risk factors of thrombosis especially atrial fibrillation. The common approach to patients with mitral valve disease and atrial fibrillation is mitral valve prosthetic replacement concomitant to Cox-Maze procedure. This allows to maintain sinus rhythm in 65-80% of patients. In the study the safety and efficacy of dabigatran in comparison with warfarin will be evaluated after the mitral valve surgery and Cox-Maze procedure.
- Being tested
- Dabigatran Etexilate, Warfarin
- Keywords
- Atrial Fibrillation, Mitral Valve Stenosis, Mitral Valve Insufficiency, Dabigatran, Biological Prosthesis, Mitral Valve Replacement, Cox-Maze Procedure
- Medical subject headings
- Mitral Valve Stenosis, Atrial Fibrillation, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran EtexilateDrug
Also called Pradaxa
Dabigatran Etexilate 150 mg capsules for oral administration twice a day
WarfarinDrug
Also called Coumadin
Warfarin 2.5 mg tablets for oral administration once a day
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran | Active comparator | Dabigatran etexilate 150 mg by mouth every 12 hours for a year Receives: Drug: Dabigatran Etexilate |
| Warfarin | Active comparator | Warfarin by mouth every 24 hours in a dose providing international normalized ratio (INR) 2.5-3.5 for a year Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis
Thrombosis of prosthetic valve, transient ischemic attack, stroke, myocardial infarction, pulmonary and systemic thromboembolic events
Measured: 1 year
Secondary outcomes (1)
Major Bleeding
Massive symptomatic intracranial, intraocular, retroperitoneal, intraarticular, pericardial bleeding or intramuscular bleeding associated with compressive syndrome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start29 Jun 2016
- Primary completion30 Jun 2018 (estimated)
- Study completion1 Dec 2018 (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 Mitral Valve Stenosis and InsufficiencyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergey Mamchur, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Investigators
- Yevgeny V Grigoriev, M.D., Ph.D., Study chair, Research Institute for Complex Problems of Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183843
- Sponsor's protocol ID
- 0546-2015-0011
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yadlapati A, Groh C, Malaisrie SC, Gajjar M, Kruse J, Meyers S, Passman R. Efficacy and safety of novel oral anticoagulants in patients with bioprosthetic valves. Clin Res Cardiol. 2016 Mar;105(3):268-72. doi: 10.1007/s00392-015-0919-z. Epub 2015 Sep 18.
PubMed 26384981Sun JC, Davidson MJ, Lamy A, Eikelboom JW. Antithrombotic management of patients with prosthetic heart valves: current evidence and future trends. Lancet. 2009 Aug 15;374(9689):565-76. doi: 10.1016/S0140-6736(09)60780-7.
PubMed 19683642
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Dabigatran Etexilate in Patients With Atrial Fibrillation After Mitral Valve Prosthetic Replacement
- ClinicalTrials.gov ID
- NCT03183843
- Acronym / sponsor ID
- 0546-2015-0011
- Keywords
- Atrial Fibrillation, Mitral Valve Stenosis, Mitral Valve Insufficiency, Dabigatran, Biological Prosthesis, Mitral Valve Replacement, Cox-Maze Procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, RussiaUniversity, hospital or other
- Study start
- 29 Jun 2016 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 12 Jun 2017 (actual)
- 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.
The efficacy and safety of anticoagulation therapy using dabigatran in comparison with warfarin will be evaluated in patients with atrial fibrillation after mitral valve prosthetic replacement concomitant with Cox-Maze procedure.
Detailed description
Patients with prosthetic mitral valves need a long-term anticoagulation therapy. After mitral valve replacement using mechanical prostheses warfarin is administrated during the whole life. Biological prostheses allows do discontinue anticoagulation 3 months after surgery in the absence of other risk factors of thrombosis especially atrial fibrillation. The common approach to patients with mitral valve disease and atrial fibrillation is mitral valve prosthetic replacement concomitant to Cox-Maze procedure. This allows to maintain sinus rhythm in 65-80% of patients. In the study the safety and efficacy of dabigatran in comparison with warfarin will be evaluated after the mitral valve surgery and Cox-Maze procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran | Active comparator | Drug: Dabigatran EtexilateDabigatran etexilate 150 mg by mouth every 12 hours for a year |
| Warfarin | Active comparator | Drug: WarfarinWarfarin by mouth every 24 hours in a dose providing international normalized ratio (INR) 2.5-3.5 for a year |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- mitral valve disease;
- atrial fibrillation;
- mitral valve prosthetic replacement with concomitant Cox-Maze Procedure;
- 18-75 years of age;
- signed informed consent form.
Key exclusion criteria (13 listed)
- mechanical valve replacement;
- repeated mitral valve surgery;
- coronary artery hemodynamically significant stenoses;
- ventricular arrhythmias;
- creatinine clearance <50 ml/min;
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 |
|---|---|---|
| Dabigatran EtexilateAlso: PradaxaDabigatran Etexilate 150 mg capsules for oral administration twice a day | Drug | Dabigatran |
| WarfarinAlso: CoumadinWarfarin 2.5 mg tablets for oral administration once a day | Drug | Warfarin |
Primary outcome
Thrombosis
Time frame: 1 year
Thrombosis of prosthetic valve, transient ischemic attack, stroke, myocardial infarction, pulmonary and systemic thromboembolic events
1 secondary outcome
Major Bleeding
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Background: PubMed 26384981Yadlapati A, Groh C, Malaisrie SC, Gajjar M, Kruse J, Meyers S, Passman R. Efficacy and safety of novel oral anticoagulants in patients with bioprosthetic valves. Clin Res Cardiol. 2016 Mar;105(3):268-72. doi: 10.1007/s00392-015-0919-z. Epub 2015 Sep 18.
- Background: PubMed 19683642Sun JC, Davidson MJ, Lamy A, Eikelboom JW. Antithrombotic management of patients with prosthetic heart valves: current evidence and future trends. Lancet. 2009 Aug 15;374(9689):565-76. doi: 10.1016/S0140-6736(09)60780-7.
- Individual participant dataSharing planned: No
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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.
Yevgeny V Grigoriev, M.D., Ph.D. study chair
Research Institute for Complex Problems of Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dabigatran Etexilate and Warfarin in people with Mitral Valve Stenosis and Insufficiency and Atrial Fibrillation, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia at 1 site in Russia.
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 13 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 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Thrombosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03183843, 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 12 Jun 2017.