Left Ventricular ThrombusPhase 3NCT05208398
Apixaban in Patients With Left Ventricular Thrombus
A Phase 3 study testing Apixaban and Warfarin in people with Left Ventricular Thrombus, run by Saud Al Babtain Cardiac Center at 1 site in Saudi Arabia.
Trial summary
Open label randomized controlled clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in treating left ventricular thrombus in patients with acute or recent myocardial infarction (MI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Left Ventricular Thrombus
- What is being tested?
- Apixaban and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 18 Feb 2018to 30 Sep 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the following criteria must be fulfilled:
- Ages between 18 and 80 years,
- History of anterior wall MI, either acute (within a week) or recent (within a month)
- Evident left ventricular thrombus (LVT) by transthoracic echocardiography,
- Naïve to oral anticoagulants (OAC)
- stable to start OAC
Who cannot join
- Other indications for OAC,
- Patients with contraindications for OAC,
- Right ventricular thrombus or atrial thrombus,
- History of confirmed stroke or other systemic embolization within the previous six months,
- High bleeding risk,
- Severe renal impairment,
- Patients with expected difficulties to follow the INR strictly.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Apixaban in Patients With Left Ventricular Thrombus Post Myocardial Infarction; A Randomized Clinical Trial
Open label randomized controlled clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in treating left ventricular thrombus in patients with acute or recent myocardial infarction (MI).
- Conditions
- Left Ventricular Thrombus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
5 mg twice daily, on top of standards of care.
WarfarinDrug
Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acue coronary syndrome management recommendations
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | Apixaban, 5 mg oral tablets, on top of updated guidelines of acute coronary syndrome management recommendations Receives: Drug: Apixaban |
| Warfarin | Active comparator | Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acute coronary syndrome management recommendations Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of left ventricular thrombus
Transthoracic, noncontrast, echocardiographic assessment.
Measured: 3 months
Secondary outcomes (2)
Resolution of left ventricular thrombus
Transthoracic, noncontrast, echocardiographic assessment.
Measured: 6 months
Safety outcome
Major Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start18 Feb 2018
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular ThrombusStudies 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
- Model description
- Open label randomized controlled clinical trial, two parallel active groups, with blinded primary study outcome assessor.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saud Al Babtain Cardiac Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208398
- Sponsor's protocol ID
- IRB-2018-08
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban in Patients With Left Ventricular Thrombus Post Myocardial Infarction; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05208398
- Acronym / sponsor ID
- IRB-2018-08
- Conditions
- Left Ventricular Thrombus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Saud Al Babtain Cardiac CenterOther government
- Study start
- 18 Feb 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 26 Jan 2022 (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.
Open label randomized controlled clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in treating left ventricular thrombus in patients with acute or recent myocardial infarction (MI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Open label randomized controlled clinical trial, two parallel active groups, with blinded primary study outcome assessor.
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: ApixabanApixaban, 5 mg oral tablets, on top of updated guidelines of acute coronary syndrome management recommendations |
| Warfarin | Active comparator | Drug: WarfarinWarfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acute coronary syndrome management recommendations |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages between 18 and 80 years,
- History of anterior wall MI, either acute (within a week) or recent (within a month)
- Evident left ventricular thrombus (LVT) by transthoracic echocardiography,
- Naïve to oral anticoagulants (OAC)
- stable to start OAC
Key exclusion criteria (7 listed)
- Other indications for OAC,
- Patients with contraindications for OAC,
- Right ventricular thrombus or atrial thrombus,
- History of confirmed stroke or other systemic embolization within the previous six months,
- High bleeding risk,
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 |
|---|---|---|
| ApixabanAlso: Eliquis5 mg twice daily, on top of standards of care. | Drug | Apixaban |
| WarfarinWarfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acue coronary syndrome management recommendations | Drug | Warfarin |
Primary outcome
Resolution of left ventricular thrombus
Time frame: 3 months
Transthoracic, noncontrast, echocardiographic assessment.
2 secondary outcomes
Resolution of left ventricular thrombus
Time frame: 6 months
Safety outcome
Time frame: 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No. No plan to share.
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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 3 study testing Apixaban and Warfarin in people with Left Ventricular Thrombus, run by Saud Al Babtain Cardiac Center at 1 site in Saudi Arabia.
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 6 inclusion and 7 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 26 Jan 2022. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resolution of left ventricular thrombus (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 26 Jan 2022.