Rheumatic Heart DiseasePhase 3INVICTUS-ASANCT02832531
INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Superiority
A Phase 3 study testing Rivaroxaban (15 mg) and Aspirin in people with Rheumatic Heart Disease, run by Population Health Research Institute.
Trial summary
This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke. A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in high risk patients either with AF and unsuitable for VKA or without AF and with high risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Heart Disease
- What is being tested?
- Rivaroxaban (15 mg) and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Aug 2022
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RVHD diagnosed by echocardiography at any time prior to enrollment
- Age ≥18
- Increased risk of stroke by any of the following
- CHA2DS2-VASc score ≥ 2 OR
- Moderate/Severe mitral stenosis with valve area ≤2.0 cm2 OR
- Left atrial spontaneous echo contrast OR
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- Left atrial thrombus
- Heart Rhythm
- AF or Flutter and unsuitable for VKA therapy. (AF or Flutter should be documented on baseline 12-lead ECG, or on a previous 12-lead ECG, Holter monitor, in-hospital ECG rhythm strip or Pacemaker or ICD electrogram). OR
- In the absence of AF or Flutter, patients would be eligible in the presence of any one of the following:
- <!-- -->
- Left atrial enlargement ≥5.5 cm OR
- Left atrial spontaneous echo contrast OR
- Left atrial thrombus OR
- Frequent ectopic atrial activity (>1000/24 hours) on Holter monitoring
Who cannot join
- Refusal to give informed consent
- Actively involved in any study that would compromise the protocol of INVICTUS Trial
- Severe co-morbid condition with life expectancy < 1 year
- Other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region.
- Likely to have valve replacement surgery within 6 months
- Mechanical valve prosthesis or other condition requiring treatment with VKAs. Patients with deep vein thrombosis or recent pulmonary embolism can be enrolled where both VKAs and rivaroxaban are approved.
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- Contraindication to the study medication of the trial
- Allergy to rivaroxaban
- Allergy to VKAs ( non-inferiority trial)
- Allergy to aspirin ( superiority trial)
- Severe renal insufficiency with an calculated creatinine clearance (Cockcroft-Gault) <15 ml/min
- Serious bleeding in the past six months or at high risk for bleeding
- Moderate to severe hepatic impairment
- Ongoing need for dual antiplatelet therapy (patients with on-going aspirin therapy ≤100 mg per day are not excluded)
- Ongoing need for dual strong inhibitors of CYP-3a4 or p-glycoprotein inhibitor.
- Received an investigational drug in the past 30 days
- Patients considered unsuitable for trial inclusion because of unwillingness to attend follow up visits
- Women who are pregnant and/or breastfeeding
- Women of child bearing age who do not use an effective form of birth control.
About this study
Official title: INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies
This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke.
A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in high risk patients either with AF and unsuitable for VKA or without AF and with high risk factors.
- Conditions
- Rheumatic Heart Disease
- Being tested
- Rivaroxaban (15 mg), Aspirin
- Keywords
- atrial fibrillation, stroke
- Medical subject headings
- Rheumatic Heart Disease, Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (15 mg)Drug
Also called Xarelto
Rivaroxaban is superior to aspirin for the prevention of the composite of stroke or systemic embolism in patients with RVHD with AF or flutter who are unsuitable for VKA therapy, or in patients with RVHD without AF or Flutter with at least one of the following:
- Left atrial enlargement ≥ 5.5 cm, OR
- Left atrial spontaneous echo contrast OR
- Left atrial thrombus OR
- Frequent ectopic atrial activity (>1000/24 hours) on Holter ECG.
AspirinDrug
Also called acetylsalicylic acid
Rivaroxaban is superior to aspirin for the prevention of the composite of stroke or systemic embolism in patients with RVHD with AF or flutter who are unsuitable for VKA therapy, or in patients with RVHD without AF or Flutter with at least one of the following:
- Left atrial enlargement ≥ 5.5 cm, OR
- Left atrial spontaneous echo contrast OR
- Left atrial thrombus OR
- Frequent ectopic atrial activity (>1000/24 hours) on Holter ECG.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban (15 mg) | Experimental | Rivaroxaban 15 mg od (n ~ 1000) Receives: Drug: Rivaroxaban (15 mg) |
| Aspirin (ASA) | Active comparator | Aspirin 100 mg od (n~1000) Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to the first occurrence of Stroke or systemic embolism
Stroke (Ischemic, hemorrhagic or undetermined type)
Measured: Approximately 4 years
Secondary outcomes (2)
Time from randomization to the first occurrence of Myocardial Infarction (MI)
Measured: Approximately 4 years
Time from randomization to time of vascular death
Vascular death includes death due to stroke, myocardial infarction, heart failure or cardiogenic shock, sudden death or any other death due to cardiovascular causes. In addition, death due to hemorrhage will be included
Measured: Approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJan 2022 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: Focus on recruitment for non-inferiority trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart DiseaseStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832531
- Sponsor's protocol ID
- INVICTUS - ASA
- Acronym
- INVICTUS-ASA
- Status last verified
- Jul 2022
- First submitted
- 7 Jan 2016
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: cumulative participant data only
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies
- ClinicalTrials.gov ID
- NCT02832531
- Acronym / sponsor ID
- INVICTUS-ASA / INVICTUS - ASA
- Conditions
- Rheumatic Heart Disease
- Keywords
- atrial fibrillation, stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Focus on recruitment for non-inferiority trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- Jan 2022 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 14 Jul 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.
This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke.
A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in high risk patients either with AF and unsuitable for VKA or without AF and with high risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban (15 mg) | Experimental | Drug: Rivaroxaban (15 mg)Rivaroxaban 15 mg od (n ~ 1000) |
| Aspirin (ASA) | Active comparator | Drug: AspirinAspirin 100 mg od (n~1000) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- RVHD diagnosed by echocardiography at any time prior to enrollment
- Age ≥18
- Increased risk of stroke by any of the following
- Heart Rhythm
- <!-- -->
Key exclusion criteria (19 listed)
- Refusal to give informed consent
- Actively involved in any study that would compromise the protocol of INVICTUS Trial
- Severe co-morbid condition with life expectancy < 1 year
- Other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region.
- Likely to have valve replacement surgery within 6 months
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 mg)Also: XareltoRivaroxaban is superior to aspirin for the prevention of the composite of stroke or systemic embolism in patients with RVHD with AF or flutter who are unsuitable for VKA therapy, or in patients with RVHD without AF or Flutter with at least one of the following: 1. Left atrial enlargement ≥ 5.5 cm, OR 2. Left atrial spontaneous echo contrast OR 3. Left atrial thrombus OR 4. Frequent ectopic atrial activity (>1000/24 hours) on Holter ECG. | Drug | Rivaroxaban (15 mg) |
| AspirinAlso: acetylsalicylic acidRivaroxaban is superior to aspirin for the prevention of the composite of stroke or systemic embolism in patients with RVHD with AF or flutter who are unsuitable for VKA therapy, or in patients with RVHD without AF or Flutter with at least one of the following: 1. Left atrial enlargement ≥ 5.5 cm, OR 2. Left atrial spontaneous echo contrast OR 3. Left atrial thrombus OR 4. Frequent ectopic atrial activity (>1000/24 hours) on Holter ECG. | Drug | Aspirin (ASA) |
Primary outcome
Time from randomization to the first occurrence of Stroke or systemic embolism
Time frame: Approximately 4 years
Stroke (Ischemic, hemorrhagic or undetermined type)
2 secondary outcomes
Time from randomization to the first occurrence of Myocardial Infarction (MI)
Time frame: Approximately 4 years
Time from randomization to time of vascular death
Time frame: Approximately 4 years
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 19 Jul 2022.
- Individual participant dataSharing planned: No. cumulative participant data only
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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 Phase 3 study testing Rivaroxaban (15 mg) and Aspirin in people with Rheumatic Heart Disease, run by Population Health Research Institute.
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 15 inclusion and 19 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 19 Jul 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time from randomization to the first occurrence of Stroke or systemic embolism (time frame: Approximately 4 years). 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 19 Jul 2022.