Mitral Valve StenosisPhase 4NCT03673605
Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin
A Phase 4 study testing Rivaroxaban 15 mg and Warfarin in people with Mitral Valve Stenosis and Atrial Fibrillation, run by PharmEvo Pvt Ltd at 1 site in Pakistan.
Trial summary
Title: Efficacy and safety of rivaroxiban compare with vitamin K antagonist warfarin in patients with atrial fibrillation and mitral stenosis among Pakistani population. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Mitral Valve Stenosis, Atrial Fibrillation
- What is being tested?
- Rivaroxaban 15 mg and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Dec 2016to 30 Dec 2017
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both gender
- Age from 18 years up to 55 years
- Rheumatic MS (Mild moderate severe) Hemodynamic ally stable patients
- Associated AF or flutter documented on ECG
- Post PTMC or M com
- Not previously enrolled in any trial or study on NOACS
- Willing to participate
Who cannot join
- Rheumatic valve other than MS
- Prosthetic Mitral Valve Surgery
- Previous TIA or stroke
- Plan for valve replacement within six months
- Pregnancy
- History of bleeding complication
Show all 12Show fewer
- High Risk of bleeding complication
- Allergic to study drug
- Anemia (HB less than 10 g/dl)
- Raised SGPT > 2xUNL
- Creatinine clearance <30ml/min
- Not willing to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin in Patients With Atrial Fibrillation and Mitral Stenosis Among Pakistani Population
Title: Efficacy and safety of rivaroxiban compare with vitamin K antagonist warfarin in patients with atrial fibrillation and mitral stenosis among Pakistani population.
Read the detailed description
Atrial fibrillation is associated with an increase in the risk of ischemic stroke by a factor of four to five and accounts for up to 15% of strokes in persons of all ages and 30% in persons over the age of 80 years. The use of vitamin K antagonists is highly effective for stroke prevention in patients with non-valvular atrial fibrillation and is recommended for persons at increased risk. However, food and drug interactions necessitate frequent coagulation monitoring and dose adjustments, requirements that make it difficult for many patients to use such drugs in clinical practice.
Rivaroxaban is a direct factor Xa inhibitor that may provide more consistent and predictable anticoagulation than warfarin. It has been reported to prevent venous thromboembolism more effectively than enoxaparin in patients undergoing orthopedic surgery and was non-inferior to enoxaparin followed by warfarin in a study involving patients with established venous thrombosis. This trial was designed to compare once-daily oral rivaroxaban with dose-adjusted warfarin for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation who were at moderate-to-high risk for stroke
- Conditions
- Mitral Valve Stenosis, Atrial Fibrillation
- Being tested
- Rivaroxaban 15 mg, Warfarin
- Medical subject headings
- Mitral Valve Stenosis, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 15 mgDrug
Rivaroxiban in stroke prevention in patients with Mitral Stenosis and AF.
WarfarinDrug
Warfarin in stroke prevention in patients with Mitral Stenosis and AF.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Not described Receives: Drug: Rivaroxaban 15 mg |
| Warfarin | Active comparator | Not described Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging
Intracranial bleeding: symptomatic hemorrhage confirmed by CT or MRI or asymptomatic hemorrhage on follow-up GRE or SWI imaging at 1 month Recurrent ischemic lesion: symptomatic ischemic stroke confirmed by relevant neuroimagings or asymptomatic recurrent ischemic lesion on follow-up or FLAIR imaging at 12 month
Measured: 12 months
Secondary outcomes (1)
Adverse effects/complications of Rivaroxiban as compared to Warfarin in patients with Mitral Stenosis and AF.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start30 Dec 2016
- Primary completion30 Oct 2017
- Study completion30 Dec 2017
Why it stopped: No patients Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve StenosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmEvo Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673605
- Sponsor's protocol ID
- PE/NICVD/TS/Rivo/01
- Status last verified
- Dec 2016
- First submitted
- 8 Dec 2016
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin in Patients With Atrial Fibrillation and Mitral Stenosis Among Pakistani Population
- ClinicalTrials.gov ID
- NCT03673605
- Acronym / sponsor ID
- PE/NICVD/TS/Rivo/01
- Conditions
- Mitral Valve Stenosis, Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients Enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PharmEvo Pvt LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 17 Sep 2018 (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.
Title: Efficacy and safety of rivaroxiban compare with vitamin K antagonist warfarin in patients with atrial fibrillation and mitral stenosis among Pakistani population.
Detailed description
Atrial fibrillation is associated with an increase in the risk of ischemic stroke by a factor of four to five and accounts for up to 15% of strokes in persons of all ages and 30% in persons over the age of 80 years. The use of vitamin K antagonists is highly effective for stroke prevention in patients with non-valvular atrial fibrillation and is recommended for persons at increased risk. However, food and drug interactions necessitate frequent coagulation monitoring and dose adjustments, requirements that make it difficult for many patients to use such drugs in clinical practice.
Rivaroxaban is a direct factor Xa inhibitor that may provide more consistent and predictable anticoagulation than warfarin. It has been reported to prevent venous thromboembolism more effectively than enoxaparin in patients undergoing orthopedic surgery and was non-inferior to enoxaparin followed by warfarin in a study involving patients with established venous thrombosis. This trial was designed to compare once-daily oral rivaroxaban with dose-adjusted warfarin for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation who were at moderate-to-high risk for stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: Rivaroxaban 15 mg |
| Warfarin | Active comparator | Drug: Warfarin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Both gender
- Age from 18 years up to 55 years
- Rheumatic MS (Mild moderate severe) Hemodynamic ally stable patients
- Associated AF or flutter documented on ECG
- Post PTMC or M com
Key exclusion criteria (12 listed)
- Rheumatic valve other than MS
- Prosthetic Mitral Valve Surgery
- Previous TIA or stroke
- Plan for valve replacement within six months
- Pregnancy
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 |
|---|---|---|
| Rivaroxaban 15 mgRivaroxiban in stroke prevention in patients with Mitral Stenosis and AF. | Drug | Rivaroxaban |
| WarfarinWarfarin in stroke prevention in patients with Mitral Stenosis and AF. | Drug | Warfarin |
Primary outcome
Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging
Time frame: 12 months
Intracranial bleeding: symptomatic hemorrhage confirmed by CT or MRI or asymptomatic hemorrhage on follow-up GRE or SWI imaging at 1 month Recurrent ischemic lesion: symptomatic ischemic stroke confirmed by relevant neuroimagings or asymptomatic recurrent ischemic lesion on follow-up or FLAIR imaging at 12 month
1 secondary outcome
Adverse effects/complications of Rivaroxiban as compared to Warfarin in patients with Mitral Stenosis and AF.
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Individual participant dataSharing planned: Yes
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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.
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 Rivaroxaban 15 mg and Warfarin in people with Mitral Valve Stenosis and Atrial Fibrillation, run by PharmEvo Pvt Ltd at 1 site in Pakistan.
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 7 inclusion and 12 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: withdrawn, as of the sponsor's last update on 17 Sep 2018. 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 Pakistan. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2018.