Embolism and ThrombosisNCT06209892
Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular Thrombosis
A study testing Extended anticoagulation in people with Embolism and Thrombosis and Anticoagulation, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
Trial summary
A single-center, open-label, exploratory randomized controlled study is proposed with the following objectives: whether prolonging the duration of anticoagulation to 12 months, compared with 6 months of routine anticoagulation, helps to reduce major adverse cardiovascular and cerebrovascular events in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Embolism and Thrombosis, Anticoagulation
- What is being tested?
- Extended anticoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2027
- Phase
- Interventional
- 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
- ①Patients who have been clearly diagnosed with left ventricular thrombus by inpatient or outpatient cardiac ultrasound (including general ultrasound and acoustic imaging).
- ②Age >= 18 years old
Who cannot join
- Patients do not agree to participate in the study or have poor compliance in the past
- Contraindication to anticoagulation or allergy to anticoagulants ③Have received oral anticoagulation after diagnosis of left ventricular thrombus.
- Have undergone or are planning to undergo surgical procedures including left ventricular appendage thrombectomy, heart transplantation, ventricular wall tumor collapse, or valve replacement.
- Presence of other long-term indications for anticoagulation, such as mechanical valve implantation, atrial fibrillation, etc.
- Requirement for treatment with Tegretol and inability to change to clopidogrel bisulfate ⑦Presence of known malignant tumors, severe hepatic dysfunction (Child-Pugh classification B or less), severe renal dysfunction (creatinine clearance <30ml/min), anemia (Hb <100g/L), coagulation disorders and other underlying diseases, or life expectancy <3 years ⑧ Female patients are pregnant or breastfeeding ⑨ Patients with antiphospholipid syndrome
About this study
Official title: Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular
A single-center, open-label, exploratory randomized controlled study is proposed with the following objectives: whether prolonging the duration of anticoagulation to 12 months, compared with 6 months of routine anticoagulation, helps to reduce major adverse cardiovascular and cerebrovascular events in patients with left ventricular thrombosis and to reduce recurrence of thrombosis, as well as to assess their bleeding risk.
Patients with a definite diagnosis of left ventricular thrombus and age ≥18 years were included in cardiac ultrasound (including general ultrasound and sonography) and other examinations during hospitalization and outpatient visits. Exclusion criteria were detailed in the study protocol.
Read more
GROUPING: According to the duration of anticoagulation, they were divided into extended anticoagulation group (12 months) and conventional anticoagulation group (6 months).
INTERVENTION: This study is planned to extend the administration of rivaroxaban (Pulsatilla) 20 mg to 12 months in the experimental group. The conventional anticoagulation group will take the drug for 6 months Study Endpoints: The primary efficacy endpoint is a major cardiovascular-vascular adverse event at 1 year; the primary safety endpoint is bleeding of grade 3 or higher as defined by the BARC classification at 1 year.
Patient Follow-up Program: Subjects will require a total of 12 on-site follow-up visits (one per month) for safety evaluation, efficacy evaluation, medication adherence evaluation, and imaging follow-up at months 3, 6, and 12.
- Conditions
- Embolism and Thrombosis, Anticoagulation
- Being tested
- Extended anticoagulation
- Medical subject headings
- Embolism and Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended anticoagulationProcedure or surgery
This study plan will extend the duration of rivaroxaban 20mg in the experimental group to 12 months. The regular anticoagulation group will take the drug for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Conventional anticoagulation group | No intervention | Not described |
| Extended anticoagulation group | Experimental | Not described Receives: Procedure: Extended anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint
for major cardiovascular and cerebrovascular adverse events at 1 year, including: all-cause mortality, nonfatal heart attack, ischemic stroke, and acute peripheral artery embolism. fatal heart attack, ischemic stroke, and acute peripheral artery embolism
Measured: Patient completes one year of follow-up
Secondary outcomes (1)
secondary endpoint
Dissolution of left ventricular thrombus confirmed by cardiac ultrasound and no recurrence detected and/or recurrence of left ventricular thrombus detected by cardiac ultrasound after dissolution of left ventricular thrombus
Measured: Patient during one year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Embolism and ThrombosisStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihua Song, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209892
- Sponsor's protocol ID
- BJHPA-2023-017-014
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bulluck H, Vincent M, Hausenloy DJ. Optimizing the Detection of Left Ventricular Thrombus Following Acute Myocardial Infarction in the Current Era. JAMA Cardiol. 2018 Nov 1;3(11):1128-1129. doi: 10.1001/jamacardio.2018.3136. No abstract available.
PubMed 30285032Maniwa N, Fujino M, Nakai M, Nishimura K, Miyamoto Y, Kataoka Y, Asaumi Y, Tahara Y, Nakanishi M, Anzai T, Kusano K, Akasaka T, Goto Y, Noguchi T, Yasuda S. Anticoagulation combined with antiplatelet therapy in patients with left ventricular thrombus after first acute myocardial infarction. Eur Heart J. 2018 Jan 14;39(3):201-208. doi: 10.1093/eurheartj/ehx551.
PubMed 29029233Lattuca B, Bouziri N, Kerneis M, Portal JJ, Zhou J, Hauguel-Moreau M, Mameri A, Zeitouni M, Guedeney P, Hammoudi N, Isnard R, Pousset F, Collet JP, Vicaut E, Montalescot G, Silvain J; ACTION Study Group. Antithrombotic Therapy for Patients With Left Ventricular Mural Thrombus. J Am Coll Cardiol. 2020 Apr 14;75(14):1676-1685. doi: 10.1016/j.jacc.2020.01.057.
PubMed 32273033
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular
- ClinicalTrials.gov ID
- NCT06209892
- Acronym / sponsor ID
- BJHPA-2023-017-014
- Conditions
- Embolism and Thrombosis, Anticoagulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jan 2024 (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.
A single-center, open-label, exploratory randomized controlled study is proposed with the following objectives: whether prolonging the duration of anticoagulation to 12 months, compared with 6 months of routine anticoagulation, helps to reduce major adverse cardiovascular and cerebrovascular events in patients with left ventricular thrombosis and to reduce recurrence of thrombosis, as well as to assess their bleeding risk.
Patients with a definite diagnosis of left ventricular thrombus and age ≥18 years were included in cardiac ultrasound (including general ultrasound and sonography) and other examinations during hospitalization and outpatient visits. Exclusion criteria were detailed in the study protocol.
GROUPING: According to the duration of anticoagulation, they were divided into extended anticoagulation group (12 months) and conventional anticoagulation group (6 months).
INTERVENTION: This study is planned to extend the administration of rivaroxaban (Pulsatilla) 20 mg to 12 months in the experimental group. The conventional anticoagulation group will take the drug for 6 months Study Endpoints: The primary efficacy endpoint is a major cardiovascular-vascular adverse event at 1 year; the primary safety endpoint is bleeding of grade 3 or higher as defined by the BARC classification at 1 year.
Patient Follow-up Program: Subjects will require a total of 12 on-site follow-up visits (one per month) for safety evaluation, efficacy evaluation, medication adherence evaluation, and imaging follow-up at months 3, 6, and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional anticoagulation group | No intervention | – |
| Extended anticoagulation group | Experimental | Procedure: Extended anticoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ①Patients who have been clearly diagnosed with left ventricular thrombus by inpatient or outpatient cardiac ultrasound (including general ultrasound and acoustic imaging).
- ②Age >= 18 years old
Key exclusion criteria (5 listed)
- Patients do not agree to participate in the study or have poor compliance in the past
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 |
|---|---|---|
| Extended anticoagulationThis study plan will extend the duration of rivaroxaban 20mg in the experimental group to 12 months. The regular anticoagulation group will take the drug for 6 months | Procedure or surgery | Extended anticoagulation group |
Primary outcome
Primary efficacy endpoint
Time frame: Patient completes one year of follow-up
for major cardiovascular and cerebrovascular adverse events at 1 year, including: all-cause mortality, nonfatal heart attack, ischemic stroke, and acute peripheral artery embolism. fatal heart attack, ischemic stroke, and acute peripheral artery embolism
1 secondary outcome
secondary endpoint
Time frame: Patient during one year of follow-up
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 18 Jan 2024.
- Results publication: PubMed 30285032Bulluck H, Vincent M, Hausenloy DJ. Optimizing the Detection of Left Ventricular Thrombus Following Acute Myocardial Infarction in the Current Era. JAMA Cardiol. 2018 Nov 1;3(11):1128-1129. doi: 10.1001/jamacardio.2018.3136. No abstract available.
- Results publication: PubMed 29029233Maniwa N, Fujino M, Nakai M, Nishimura K, Miyamoto Y, Kataoka Y, Asaumi Y, Tahara Y, Nakanishi M, Anzai T, Kusano K, Akasaka T, Goto Y, Noguchi T, Yasuda S. Anticoagulation combined with antiplatelet therapy in patients with left ventricular thrombus after first acute myocardial infarction. Eur Heart J. 2018 Jan 14;39(3):201-208. doi: 10.1093/eurheartj/ehx551.
- Results publication: PubMed 32273033Lattuca B, Bouziri N, Kerneis M, Portal JJ, Zhou J, Hauguel-Moreau M, Mameri A, Zeitouni M, Guedeney P, Hammoudi N, Isnard R, Pousset F, Collet JP, Vicaut E, Montalescot G, Silvain J; ACTION Study Group. Antithrombotic Therapy for Patients With Left Ventricular Mural Thrombus. J Am Coll Cardiol. 2020 Apr 14;75(14):1676-1685. doi: 10.1016/j.jacc.2020.01.057.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Extended anticoagulation in people with Embolism and Thrombosis and Anticoagulation, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Jan 2024. 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.
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?
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?
Primary efficacy endpoint (time frame: Patient completes one year of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06209892, which also lists 3 linked publications.
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 18 Jan 2024.