Left Ventricular ThrombusPhase 3APEXNCT07709780
Apixaban Versus Warfarin for Left Ventricular Thrombus
A Phase 3 study testing Apixaban and Warfarin in people with Left Ventricular Thrombus, run by University of Arizona at 1 site in United States.
Trial summary
Left ventricular thrombus is a blood clot that forms in the left ventricle and is associated with risk of systemic embolism and ischemic stroke. Warfarin has historically been used for anticoagulation in this condition, but it requires frequent international normalized ratio monitoring and is affected by dietary and… Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2026to 1 Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years
- LV thrombus confirmed within 14 days prior to randomization by CMR or contrast TTE or cardiac CT; baseline CMR required pre-randomization (or ≤7 days post-randomization if clinically unavoidable)
- Candidate for oral anticoagulation for ≥3 months
- Able to provide informed consent.
Who cannot join
- Absolute indication for VKA (mechanical valve, moderate-severe rheumatic MS and antiphospholipid syndrome) or clear preference or contraindication for one of the study drugs precluding randomization (see below)
- Antiphospholipid syndrome
- Estimated CrCl <15 mL/min or dialysis
- Severe hepatic impairment (ICD-10: K70.40, K70.41, K71.10, K71.11, K72.00, K72.01, K72.10, K72.11, K72.90, K72.91)
- Active clinically significant bleeding
- Platelets <50,000/µL
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- Pregnancy or lactation; women of childbearing potential unwilling to use contraception
- Life expectancy <1 year or other conditions compromising follow-up
- Additional contraindications to use of warfarin or apixaban. This includes, but is not limited to:
- Active pathological bleeding, major bleeding diathesis, or known blood dyscrasia
- Recent or planned surgery involving the central nervous system or eye, traumatic surgery with large open surfaces, or procedures (spinal/epidural puncture or major regional block anesthesia) where bleeding cannot be safely controlled.
- Conditions associated with high risk of bleeding such as threatened abortion, eclampsia, severe preeclampsia, or malignant/uncontrolled hypertension.
- History of severe hypersensitivity or allergy to warfarin or apixaban.
- Ongoing treatment with a combined P-gp and strong CYP3A4 inhibitor or inducer that cannot be safely discontinued or substituted. Examples include strong combined inhibitors such as ketoconazole, itraconazole, ritonavir or posiconazole, and strong combined inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona, 85724
Tushar Acharya, MD, MPH
Song Peng Ang, MD
About this study
Official title: Apixaban vs. Warfarin in Left Ventricular Thrombus: A Randomized, Noninferiority Trial
Left ventricular thrombus is a blood clot that forms in the left ventricle and is associated with risk of systemic embolism and ischemic stroke. Warfarin has historically been used for anticoagulation in this condition, but it requires frequent international normalized ratio monitoring and is affected by dietary and drug interactions. Apixaban is a direct oral factor Xa inhibitor with fixed dosing and no routine anticoagulation monitoring requirement, and it is increasingly used in clinical practice for left ventricular thrombus, although definitive randomized evidence remains limited.
This randomized, noninferiority trial will compare apixaban with warfarin for treatment of left ventricular thrombus. Eligible adults with recently confirmed left ventricular thrombus will be randomized 1:1 to apixaban or warfarin. The primary endpoint is complete left ventricular thrombus resolution at 3 months assessed by cardiac magnetic resonance imaging. Participants will be followed through 12 months for thrombus-related, bleeding, cardiovascular, and mortality outcomes.
- Conditions
- Left Ventricular Thrombus
- Being tested
- Apixaban, Warfarin
- Keywords
- Cardiac Thrombus, Intracardiac Thrombus, Systemic Embolism, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Apixaban 5 mg orally twice daily
WarfarinDrug
Warfarin will be prescribed with dose adjustment to maintain INR 2.0-3.0.
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | Participants randomized to apixaban will receive oral apixaban for treatment of left ventricular thrombus according to standard clinical dosing and follow-up. Receives: Drug: Apixaban |
| Warfarin | Active comparator | Participants randomized to warfarin will receive oral dose-adjusted warfarin for treatment of left ventricular thrombus according to standard clinical care. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Left Ventricular Thrombus Resolution at 3 Months
Proportion of participants with complete resolution of left ventricular thrombus at 3 months, assessed by cardiac magnetic resonance imaging. The primary noninferiority comparison will use the absolute between-group difference in the proportion of participants with complete thrombus resolution, apixaban minus warfarin.
Measured: 3 months after randomization
Secondary outcomes (8)
Major Bleeding
Proportion of participants with major bleeding defined as BARC type 3 or 5 bleeding.
Measured: 6 months
Change in LV Thrombus Volume
Change in thrombus volume assessed by CMR
Measured: Baseline to 3, 6, or 12 months
Left Ventricular Remodeling
Change in left ventricular ejection fraction and left ventricular volumes on follow-up imaging.
Measured: Baseline to 3, 6,12 months
Recurrent LV Thrombus
Proportion of participants with recurrent LV thrombus after documented resolution.
Measured: 12 months
Ischemic Stroke
Proportion of participants with ischemic stroke.
Measured: 12 months
Systemic embolism
Proportion of participants with systemic embolism
Measured: 12 months
Cardiovascular Mortality
Proportion of participants with cardiovascular death.
Measured: 12 months
All-Cause Mortality
Proportion of participants with death from any cause.
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 Jul 2026
- Study start22 Jun 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tushar Acharya, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709780
- Sponsor's protocol ID
- STUDY00007421
- Acronym
- APEX
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban vs. Warfarin in Left Ventricular Thrombus: A Randomized, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT07709780
- Acronym / sponsor ID
- APEX / STUDY00007421
- Conditions
- Left Ventricular Thrombus
- Keywords
- Cardiac Thrombus, Intracardiac Thrombus, Systemic Embolism, Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 17 Jul 2026 (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.
Left ventricular thrombus is a blood clot that forms in the left ventricle and is associated with risk of systemic embolism and ischemic stroke. Warfarin has historically been used for anticoagulation in this condition, but it requires frequent international normalized ratio monitoring and is affected by dietary and drug interactions. Apixaban is a direct oral factor Xa inhibitor with fixed dosing and no routine anticoagulation monitoring requirement, and it is increasingly used in clinical practice for left ventricular thrombus, although definitive randomized evidence remains limited.
This randomized, noninferiority trial will compare apixaban with warfarin for treatment of left ventricular thrombus. Eligible adults with recently confirmed left ventricular thrombus will be randomized 1:1 to apixaban or warfarin. The primary endpoint is complete left ventricular thrombus resolution at 3 months assessed by cardiac magnetic resonance imaging. Participants will be followed through 12 months for thrombus-related, bleeding, cardiovascular, and mortality outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: ApixabanParticipants randomized to apixaban will receive oral apixaban for treatment of left ventricular thrombus according to standard clinical dosing and follow-up. |
| Warfarin | Active comparator | Drug: WarfarinParticipants randomized to warfarin will receive oral dose-adjusted warfarin for treatment of left ventricular thrombus according to standard clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- LV thrombus confirmed within 14 days prior to randomization by CMR or contrast TTE or cardiac CT; baseline CMR required pre-randomization (or ≤7 days post-randomization if clinically unavoidable)
- Candidate for oral anticoagulation for ≥3 months
- Able to provide informed consent.
Key exclusion criteria (14 listed)
- Absolute indication for VKA (mechanical valve, moderate-severe rheumatic MS and antiphospholipid syndrome) or clear preference or contraindication for one of the study drugs precluding randomization (see below)
- Antiphospholipid syndrome
- Estimated CrCl <15 mL/min or dialysis
- Severe hepatic impairment (ICD-10: K70.40, K70.41, K71.10, K71.11, K72.00, K72.01, K72.10, K72.11, K72.90, K72.91)
- Active clinically significant bleeding
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 |
|---|---|---|
| ApixabanApixaban 5 mg orally twice daily | Drug | Apixaban |
| WarfarinWarfarin will be prescribed with dose adjustment to maintain INR 2.0-3.0. | Drug | Warfarin |
Primary outcome
Complete Left Ventricular Thrombus Resolution at 3 Months
Time frame: 3 months after randomization
Proportion of participants with complete resolution of left ventricular thrombus at 3 months, assessed by cardiac magnetic resonance imaging. The primary noninferiority comparison will use the absolute between-group difference in the proportion of participants with complete thrombus resolution, apixaban minus warfarin.
8 secondary outcomes
Major Bleeding
Time frame: 6 months
Change in LV Thrombus Volume
Time frame: Baseline to 3, 6, or 12 months
Left Ventricular Remodeling
Time frame: Baseline to 3, 6,12 months
Recurrent LV Thrombus
Time frame: 12 months
Ischemic Stroke
Time frame: 12 months
Systemic embolism
Time frame: 12 months
Cardiovascular Mortality
Time frame: 12 months
All-Cause Mortality
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- 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.
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 University of Arizona at 1 site in United States.
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 14 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tushar Acharya, MD, MPH (520-626-0968, tacharya@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Left Ventricular Thrombus Resolution at 3 Months (time frame: 3 months after randomization). 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 Jul 2026.