Left Ventricular ThrombosisPhase 3NCT02982590
Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus
A Phase 3 study testing Apixaban 5 MG Oral Tablet [ELIQUIS] and Warfarin Sodium in people with Left Ventricular Thrombosis, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
The purpose of this study is to compare the novel oral anticoagulant apixaban with the standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus over 3 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Left Ventricular Thrombosis
- What is being tested?
- Apixaban 5 MG Oral Tablet [ELIQUIS] and Warfarin Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteMalaysia
- Study dates
- Nov 2016to Nov 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80 years old
- Presence of LV thrombus or spontaneous echo contrast (SEC) grade 3 or 4 (Patel VG 1996), with regional wall motion abnormalities
- HASBLED score less than 3
- No episodes of major bleeding in the past 6 months a) Major bleeding defined as i. episodes of bleeding with significant drop in haemoglobin(Hb)level of at least 2gm/dL - Includes upper and lower gastrointestinal bleed ii. The need for blood transfusion (pack cell) of at least 2 unit iii. Recent surgery with bleeding complications and lost of Hb as in (i) or (ii) iv. Any intracranial bleeds with neurological deficits
Who cannot join
- Patient with unstable arrhythmias and/or recurrent cardiogenic shock
- Patient with large ischemic stroke on recruitment-defined as involving >1/3 of cerebral hemisphere or deemed to have high chance of haemorrhagic transformation
- Patient with permanent pacemaker
- Patient who is post valve replacement therapy
- Patient who is pregnant.
- Patient with advanced kidney disease at stage V and not on dialysis (CrCl <15 mL/min)
- Patient with advanced liver disease with coagulopathy
- Patient with organized and old left ventricular thrombus
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Universiti Sains Malaysia
Kota Bharu, Kelanatan, 16150
About this study
Official title: Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus: A Prospective Randomized Outcome Blinded Study on the Size Reduction or Resolution of Left Ventricular Thrombus
The purpose of this study is to compare the novel oral anticoagulant apixaban with the standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus over 3 months.
Read the detailed description
Current treatment for left ventricular thrombus is anti-coagulant or blood thinning agent known as warfarin. Recently at least three novel oral anticoagulant agents were used in the treatment of atrial fibrillation, pulmonary embolism and deep vein thrombosis (DVT).
Novel oral anticoagulant drugs will require no blood taking for INR monitoring, hence less visit and more convenience to patients. Latest studies also showed lesser rate of bleeding as compared to warfarin and hence relatively safer.
- Conditions
- Left Ventricular Thrombosis
- Being tested
- Apixaban 5 MG Oral Tablet [ELIQUIS], Warfarin Sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban 5 MG Oral Tablet [ELIQUIS]Drug
Also called ELIQUIS
Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
Warfarin SodiumDrug
Also called Coumadin
as controlled arm since warfarin is the standard therapy for LV thrombus
| Study group | Role | What they receive |
|---|---|---|
| warfarin sodium | Active comparator | warfarin daily, dosage according to INR monitor. Aim INR 2-3 Receives: Drug: Warfarin Sodium |
| apixaban | Experimental | Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months. Receives: Drug: Apixaban 5 MG Oral Tablet [ELIQUIS] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Left Ventricular Thrombus (LVT) Size
Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment
Measured: 3 months
Secondary outcomes (3)
Change of Left Ventricular Thrombosis (LVT) by More Than 50%
Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms.
Measured: 3 months
Clinically Definite Cardiac Embolic Ischemic Stroke
Number of participants who showed evidence of clinically definite cardiac embolic ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by CT scan
Measured: 3 months
Life Threatening Bleeding
Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Left Ventricular ThrombosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Jantung Negara
- Responsible party
- Principal investigator, Dr W. Yus Haniff W. Isa, Universiti Sains Malaysia
- Investigators
- Dr W. Yus Haniff W. Isa, M.MED, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982590
- Sponsor's protocol ID
- 304/PPSP/61313197
- Status last verified
- Jun 2021
- First submitted
- 21 Nov 2016
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus: A Prospective Randomized Outcome Blinded Study on the Size Reduction or Resolution of Left Ventricular Thrombus
- ClinicalTrials.gov ID
- NCT02982590
- Acronym / sponsor ID
- 304/PPSP/61313197
- Conditions
- Left Ventricular Thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Institut Jantung Negara
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the novel oral anticoagulant apixaban with the standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus over 3 months.
Detailed description
Current treatment for left ventricular thrombus is anti-coagulant or blood thinning agent known as warfarin. Recently at least three novel oral anticoagulant agents were used in the treatment of atrial fibrillation, pulmonary embolism and deep vein thrombosis (DVT).
Novel oral anticoagulant drugs will require no blood taking for INR monitoring, hence less visit and more convenience to patients. Latest studies also showed lesser rate of bleeding as compared to warfarin and hence relatively safer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warfarin sodium | Active comparator | Drug: Warfarin Sodiumwarfarin daily, dosage according to INR monitor. Aim INR 2-3 |
| apixaban | Experimental | Drug: Apixaban 5 MG Oral Tablet [ELIQUIS]Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 - 80 years old
- Presence of LV thrombus or spontaneous echo contrast (SEC) grade 3 or 4 (Patel VG 1996), with regional wall motion abnormalities
- HASBLED score less than 3
- No episodes of major bleeding in the past 6 months a) Major bleeding defined as i. episodes of bleeding with significant drop in haemoglobin(Hb)level of at least 2gm/dL - Includes upper and lower gastrointestinal bleed ii. The need for blood transfusion (pack cell) of at least 2 unit iii. Recent surgery with bleeding complications and lost of Hb as in (i) or (ii) iv. Any intracranial bleeds with neurological deficits
Key exclusion criteria (8 listed)
- Patient with unstable arrhythmias and/or recurrent cardiogenic shock
- Patient with large ischemic stroke on recruitment-defined as involving >1/3 of cerebral hemisphere or deemed to have high chance of haemorrhagic transformation
- Patient with permanent pacemaker
- Patient who is post valve replacement therapy
- Patient who is pregnant.
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 |
|---|---|---|
| Apixaban 5 MG Oral Tablet [ELIQUIS]Also: ELIQUISApixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication. | Drug | apixaban |
| Warfarin SodiumAlso: Coumadinas controlled arm since warfarin is the standard therapy for LV thrombus | Drug | warfarin sodium |
Primary outcome
Percent Change in Left Ventricular Thrombus (LVT) Size
Time frame: 3 months
Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment
3 secondary outcomes
Change of Left Ventricular Thrombosis (LVT) by More Than 50%
Time frame: 3 months
Clinically Definite Cardiac Embolic Ischemic Stroke
Time frame: 3 months
Life Threatening Bleeding
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Dr W. Yus Haniff W. Isa, M.MED principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apixaban 5 MG Oral Tablet [ELIQUIS] and Warfarin Sodium in people with Left Ventricular Thrombosis, run by Universiti Sains Malaysia at 1 site in Malaysia.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 8 Jul 2021. 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 Malaysia. 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 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?
Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Left Ventricular Thrombus (LVT) Size (time frame: 3 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 8 Jul 2021.