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Thrombus of Left VentricleLV-ThrombusNCT05028777

Cohort of Patients With Left Ventricular Thrombus: Management and Outcomes in the Direct Oral Anticoagulants Era

An observational study of Thrombus of Left Ventricle, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators' primary objective is to assess whether a difference in the occurrence of bleeding events exist between patients with LVT treated with DOACs as compared to those treated with VKAs. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thrombus of Left Ventricle
How many people
98 participants
Where
1 siteSwitzerland
Study dates
1 Jan 2021to 28 Feb 2026
How long will I take part?
5 Years
Phase
Observational
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

Study population: This is an observational, retrospective and prospective, monocentric study including all patients diagnosed with left ventricular thrombus through different imaging modalities (echocardiography, CT or MRI)

Who may be able to join

  • Patients at least 18 years old at enrolment
  • With a LVT identified at echocardiography, MRI or CT between January 1st, 2013 and July 31st, 2020
  • Treated at least once at the Inselspital or in another site of the Insel Gruppe
  • Able to provide a written informed consent

Who cannot join

  • Documented refusal

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Department of Cardiology, University Hospital Bern

    Bern, 3010

Other trials in Switzerland

About this study

The investigators' primary objective is to assess whether a difference in the occurrence of bleeding events exist between patients with LVT treated with DOACs as compared to those treated with VKAs.

Read the detailed description

Left ventricular thrombus (LVT) is a well-known complication of left ventricle (LV) systolic dysfunction that can be seen in acute systolic dysfunction, i.e. induced by an acute myocardial infarction (AMI) or Takotsubo cardiomyopathy, and in chronic heart failure with reduced ejection fraction (HFrEF), whatever the cause.

Improvements in the management of AMI, particularly with the implementation of primary percutaneous coronary intervention (PCI), have led to a striking reduction in the occurrence of LVT in patients with AMI from about 30% in the thrombolytic era to about 4% nowadays, according to echocardiographic assessment. On the other hand prognosis of patients with LVT didn't change over time: mortality and risk of embolic events associated with this condition are still high.

A limited amount of evidence shows that oral anticoagulation is associated in the majority of patients with both resolution of LVT and reduction in ischemic events. This benefit comes at the cost of bleeding complications, which have been demonstrated to impact on mortality, especially in patients after AMI receiving an oral anticoagulant on top of a dual antiplatelet therapy (so-called triple antithrombotic therapy).

Current European and American guidelines on treatment of myocardial infarction with ST-elevation do not make strong recommendations for the management of LVT, whereas guidelines on treatment of heart failure do not give any. The European Society of Cardiology recommends an anticoagulation treatment for up to 6 months from diagnosis in case of LVT thrombus after AMI and the decision to continue the therapy after 6 months should be taken on the basis of echocardiographic follow-up (class IIa level of evidence C). The American College of Cardiology and American Heart Association (AHA) gives a similar recommendation (IIaC), however specifically mentioning vitamin K antagonists (VKAs) and a target INR (international normalized ratio) 2.0-2.5 for 3 months on top of dual antiplatelet therapy (DAPT). They also propose to consider an anticoagulant therapy for patients with severe anterior wall motion after STEMI but without LVT (IIbC). The AHA and American Stroke Association published in 2014 their last recommendations for secondary stroke prevention, which are in line with the above mentioned guidelines. Direct oral anticoagulants (DOACs) are mentioned as an alternative to VKAs (IIbC).

All guidelines agree that DOACs for LVT treatment cannot be recommended as first-line therapy because of the scarce evidence, based on case reports small case series and only one large retrospective study (RED VELVT study, published on April 22, 2020).

However, in clinical practice because of the establishment of DOACs over VKAs as first-line therapy to prevent embolic events in patients with atrial fibrillation, those are prescribed off-label to a significant number of patients with LVT. DOACs, as compared to VKAs, showed a greater efficacy regarding prevention of ischemic and hemorrhagic stroke and systemic embolic events in atrial fibrillation, but an increased risk of gastrointestinal bleedings.

The pathophysiology of thrombus formation in a left ventricle with regional wall motion abnormalities and in left atrium with atrial fibrillation is very similar and it implies a blood stasis as main mechanism. Thus one could expect that DOACs, which have been demonstrated to be superior to VKAs in term of prevention of embolic events in atrial fibrillation, have a similar effect on treatment of LVT. However, the first large retrospective study including 541 patients with LVT, of which 421 treated with anticoagulation showed an increased risk of embolic events at 1 year among patients with LVT treated with DOACs as compared to those on VKAs; occurrence of bleeding events was not reported.

Beside the above mentioned uncertainty concerning duration and type of treatment (VKAs versus DOACs) in LVT, there are also some issues concerning the imaging modality used for the diagnosis of LVT. Several studies comparing the diagnostic performance of transthoracic echocardiography (TTE) versus cardiac magnetic resonance (CMR) showed a roughly 30% sensitivity of TTE when taking delayed-enhancement CMR (DE-CMR) as gold standard. With the growing use of CMR, an increasing number of patients are diagnosed with small left ventricular thrombi, which would have been missed in usual clinical practice and which seem to be associated with an embolic risk similar to thrombi detected by TTE.

Keywords
Left Ventricular Assist Device, Acute Myocardial Infarction, Left Ventricular or Left Ventricle, Dual Antiplatelet Therapy, Direct Oral Anticoagulant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05028777
Study groupRoleWhat they receive
Patients diagnosed with left ventricular thrombusAll patients diagnosed with left ventricular thrombus through different imaging modalities (echocardiography, CT or MRI) and who have been diagnosed and/or treated at the Inselspital or another site of the Insel Gruppe.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The occurrence at 1 year of bleeding

    Primary combined endpoint includes the occurrence at 1 year of bleeding BARC (Bleeding Academic Research) Consortium type 2, 3 or 5.

    Measured: 1 year

Secondary outcomes (8)
  1. Rate of patients with arterial systemic embolic event

    Combined endpoint of arterial systemic embolic event, including ischemic stroke, myocardial infarction, peripheral embolism (e.g. splenic infarction, renal infarction, bowel infarction, acute embolic limb ischemia) at 1, 2 and 5 years.

    Measured: 1, 2 and 5 years

  2. Rate of patients with ischemic stroke

    Each arterial systemic embolic event considered separately at 1, 2 and 5 years

    Measured: 1, 2 and 5 years

  3. Rate of patients with myocardial infraction

    Each arterial systemic embolic event considered separately at 1, 2 and 5 years

    Measured: 1, 2 and 5 years

  4. Rate of patients with peripheral embolism

    Each arterial systemic embolic event considered separately at 1, 2 and 5 years

    Measured: 1, 2 and 5 years

  5. Rate of patients with transient ischemic attack

    Transient ischemic attack at 1, 2 and 5 years

    Measured: 1, 2 and 5 years

  6. Rate of patients with pulmonary embolism

    Pulmonary embolism at 1, 2 and 5 years

    Measured: 1, 2 and 5 years

  7. All-cause mortality

    All-cause mortality at 1, 2 and 5 year(s)

    Measured: 1, 2 and 5 years

  8. LVT size/resolution

    LVT size/resolution at follow-up imaging

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2021
  2. Study start1 Jan 2021
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
98 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05028777
Sponsor's protocol ID
2020-02187
Acronym
LV-Thrombus
Status last verified
Oct 2026
First submitted
25 Aug 2021
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Thrombus of Left Ventricle, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

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 1 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 4 Nov 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 Switzerland. 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.

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?

The occurrence at 1 year of bleeding (time frame: 1 year). 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 4 Nov 2026.

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