Ventricular Mural ThrombosisR-DISSOLVENCT04970381

An Exploratory stuDy of effectIveneSs and Safety of rivarOxaban in Patients With Left VEntricular Thrombus (R-DISSOLVE)

A study testing Rivaroxaban in people with Ventricular Mural Thrombosis, run by China National Center for Cardiovascular Diseases at 1 site in China.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Ventricular Mural Thrombosis
What is being tested?: Rivaroxaban
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteChina
Study dates: 27 Sep 2020to 30 Oct 2022
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients over 18 years old;
Patients with left ventricular thrombus newly found by body surface ultrasound less than or equal to 3 months before selection, with no limitation on basic diseases;
Patients who received standard anticoagulant therapy for less than 4 weeks before enrollment did not use antiplatelet drugs or only used single antiplatelet drugs;
The patients voluntarily joined the study and signed the informed consent.

Who cannot join

Patients with contraindications to rivaroxaban anticoagulation therapy;
Patients with a history of acute pulmonary embolism or deep venous thrombosis within a week need intensive anticoagulant therapy;
Patients with history of hemorrhagic stroke within one week;
Patients with cardiac benign and malignant tumors;
Aspirin and P2Y12 receptor antagonists should be kept;
In patients with severe hepatic and renal insufficiency, alanine aminotransferase > 3 times the upper limit and total bilirubin > 2 times the upper limit, creatinine clearance rate < 15ml / min / 1.73m2;

Show all 12Show fewer

The patient's history of intracerebral hemorrhage and active hemorrhage was 8 months;
Patients with hematological diseases, hemoglobin < 100g / L, platelet < 80 x 10^9 / L;
Women with pregnancy status, planned pregnancy and lactation period;
Patients with life expectancy less than 1 year;
Patients enrolled in other clinical studies;
Other situations considered unsuitable by the researcher. Note: anticoagulant therapy can be given to patients with left ventricular thrombosis combined with hemorrhagic stroke ≥ 4 weeks or recent ischemic stroke / transient ischemic attack according to the specific situation.

Trial locations and contacts

1 site in 1 country.

China1 site

Fuwai Hospital, Chinese Academy of Medical Sciences & Pecking Union Medical College
Beijing, 100037

Other trials in China

About this study

Official title: An Exploratory Study of Effectiveness and Safety of Rivaroxaban in Patients With Left Ventricular Thrombus

To study the effect of rivaroxaban anticoagulant therapy for 12 weeks in patients with left ventricular mural thrombus by contrast echocardiography before and after treatment, so as to provide basis and foundation for further study and treatment selection in the future; To provide further relevant data for the treatment outcome, treatment duration and influencing factors of left ventricular mural thrombosis; It is of great sociological and health economic significance to find more effective and safe anticoagulant treatment strategies for patients with left ventricular mural thrombosis, which will reduce the incidence of embolism and bleeding.

Conditions: Ventricular Mural Thrombosis
Being tested: Rivaroxaban

What participants receive

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

RivaroxabanDrug
Rivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks. The dosage of rivaroxaban was typically 20mg once daily, or 15mg once daily if patients were on dual antiplateletagents, or with creatinine clearance of 30-50mL/min.

Study groups in NCT04970381
Study group	Role	What they receive
Rivaroxaban	Experimental	Rivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks. The dosage of rivaroxaban was typically 20mg once daily, or 15mg once daily if patients were on dual antiplateletagents, or with creatinine clearance of 30-50mL/min. Receives: Drug: Rivaroxaban

What is being measured

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

Number of Participants With Left Ventricular Thrombus Resolution at 12 Weeks/Number of Participants at 12 Weeks
the rate of left ventricular thrombus resolution at 12 weeks=Number of Participants with left ventricular thrombus resolution at 12 weeks/Number of Participants at 12 weeks
Measured: 12 weeks

Secondary outcomes (3)

Number of Participants With Left Ventricular Thrombus Resolution at 6 Weeks/Number of Participants at 6 Weeks
The left ventricular thrombus resolution rate at 6 weeks=Number of Participants With Left Ventricular Thrombus Resolution at 6 Weeks/Number of Participants at 6 Weeks
Measured: 6 weeks
Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 6 Weeks/Number of Participants at 6 Weeks
The left ventricular thrombus resolution or reduction rate at 6 weeks=Number of Participants With Left Ventricular Thrombus Resolution or reduction at 6 Weeks/Number of Participants at 6 Weeks
Measured: 6 weeks
Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 12 Weeks/Number of Participants at 12 Weeks
The left ventricular thrombus resolution or reduction rate at 12 weeks=Number of Participants With Left Ventricular Thrombus Resolution or reduction at 12 Weeks/Number of Participants at 12 Weeks
Measured: 12 weeks

Timeline

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

27 Sep 202030 Oct 2022

First posted21 Jul 2021
Study start27 Sep 2020
Primary completion30 Oct 2022
Study completion30 Oct 2022

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.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Ventricular Mural ThrombosisStudies of the same condition, open and under way.
More trials run by China National Center for Cardiovascular DiseasesThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04970381
Sponsor's protocol ID: FW-2020-1380
Acronym: R-DISSOLVE
Status last verified: Feb 2024
First submitted: 11 Jul 2021
Last updated: 2 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Lee JM, Park JJ, Jung HW, Cho YS, Oh IY, Yoon CH, Suh JW, Chun EJ, Choi SI, Youn TJ, Lim C, Cho GY, Chae IH, Park KH, Choi DJ. Left ventricular thrombus and subsequent thromboembolism, comparison of anticoagulation, surgical removal, and antiplatelet agents. J Atheroscler Thromb. 2013;20(1):73-93. doi: 10.5551/jat.13540. Epub 2012 Sep 18.
PubMed 22986555
O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX, Anderson JL, Jacobs AK, Halperin JL, Albert NM, Brindis RG, Creager MA, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Kushner FG, Ohman EM, Stevenson WG, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 Jan 29;127(4):e362-425. doi: 10.1161/CIR.0b013e3182742cf6. Epub 2012 Dec 17. No abstract available.
PubMed 23247304
Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PubMed 28886621
Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
PubMed 15842354
Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Stork S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27.
PubMed 28844192
Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, van Eickels M, Cohen A; X-TRA study and CLOT-AF registry investigators. Left atrial thrombus resolution in atrial fibrillation or flutter: Results of a prospective study with rivaroxaban (X-TRA) and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2016 Aug;178:126-34. doi: 10.1016/j.ahj.2016.05.007. Epub 2016 May 17.
PubMed 27502860
Cai Y, Yang Q, Quan X, Lang X, Yu L, Yang Y, Zhu J, Liang Y. Impact of left ventricular ejection fraction on left ventricular thrombus resolution. J Cardiothorac Surg. 2026 Apr 21;21(1):543. doi: 10.1186/s13019-026-04106-9.
PubMed 42015174
Yang Q, Quan X, Zhang Y, Feng G, Zhang T, Wang C, Yu D, Yu L, Yang Y, Zhu J, Liang Y. An exploratory study of effectiveness and safety of rivaroxaban in patients with left ventricular thrombus (R-DISSOLVE). J Thromb Thrombolysis. 2023 May;55(4):649-659. doi: 10.1007/s11239-023-02790-1. Epub 2023 Mar 20.
PubMed 36940069

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Study of Effectiveness and Safety of Rivaroxaban in Patients With Left Ventricular Thrombus
ClinicalTrials.gov ID: NCT04970381
Acronym / sponsor ID: R-DISSOLVE / FW-2020-1380
Conditions: Ventricular Mural Thrombosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: China National Center for Cardiovascular DiseasesOther government
Study start: 27 Sep 2020 (actual)
Primary completion: 30 Oct 2022 (actual)
Study completion: 30 Oct 2022 (actual)
First posted: 21 Jul 2021 (actual)
Results: Posted 2 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rivaroxaban	Experimental	Drug: RivaroxabanRivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks. The dosage of rivaroxaban was typically 20mg once daily, or 15mg once daily if patients were on dual antiplateletagents, or with creatinine clearance of 30-50mL/min.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients over 18 years old;
Patients with left ventricular thrombus newly found by body surface ultrasound less than or equal to 3 months before selection, with no limitation on basic diseases;
Patients who received standard anticoagulant therapy for less than 4 weeks before enrollment did not use antiplatelet drugs or only used single antiplatelet drugs;
The patients voluntarily joined the study and signed the informed consent.

Key exclusion criteria (12 listed)

Patients with contraindications to rivaroxaban anticoagulation therapy;
Patients with a history of acute pulmonary embolism or deep venous thrombosis within a week need intensive anticoagulant therapy;
Patients with history of hemorrhagic stroke within one week;
Patients with cardiac benign and malignant tumors;
Aspirin and P2Y12 receptor antagonists should be kept;

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
RivaroxabanRivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks. The dosage of rivaroxaban was typically 20mg once daily, or 15mg once daily if patients were on dual antiplateletagents, or with creatinine clearance of 30-50mL/min.	Drug	Rivaroxaban

Primary outcome

Number of Participants With Left Ventricular Thrombus Resolution at 12 Weeks/Number of Participants at 12 Weeks
Time frame: 12 weeks
the rate of left ventricular thrombus resolution at 12 weeks=Number of Participants with left ventricular thrombus resolution at 12 weeks/Number of Participants at 12 weeks

3 secondary outcomes

Number of Participants With Left Ventricular Thrombus Resolution at 6 Weeks/Number of Participants at 6 Weeks
Time frame: 6 weeks
Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 6 Weeks/Number of Participants at 6 Weeks
Time frame: 6 weeks
Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 12 Weeks/Number of Participants at 12 Weeks
Time frame: 12 weeks

Results and safety

Results posted to the registry on 2 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rivaroxaban	75	66

Primary outcome: Number of Participants With Left Ventricular Thrombus Resolution at 12 Weeks/Number of Participants at 12 Weeks

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Rivaroxaban n = 64
Value	50

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rivaroxaban	7 of 75 (9.3%)	1 of 75 (1.3%)	2 of 75

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22986555Lee JM, Park JJ, Jung HW, Cho YS, Oh IY, Yoon CH, Suh JW, Chun EJ, Choi SI, Youn TJ, Lim C, Cho GY, Chae IH, Park KH, Choi DJ. Left ventricular thrombus and subsequent thromboembolism, comparison of anticoagulation, surgical removal, and antiplatelet agents. J Atheroscler Thromb. 2013;20(1):73-93. doi: 10.5551/jat.13540. Epub 2012 Sep 18.
Background: PubMed 23247304O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX, Anderson JL, Jacobs AK, Halperin JL, Albert NM, Brindis RG, Creager MA, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Kushner FG, Ohman EM, Stevenson WG, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 Jan 29;127(4):e362-425. doi: 10.1161/CIR.0b013e3182742cf6. Epub 2012 Dec 17. No abstract available.
Background: PubMed 28886621Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
Background: PubMed 15842354Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
Background: PubMed 28844192Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Stork S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27.
Background: PubMed 27502860Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, van Eickels M, Cohen A; X-TRA study and CLOT-AF registry investigators. Left atrial thrombus resolution in atrial fibrillation or flutter: Results of a prospective study with rivaroxaban (X-TRA) and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2016 Aug;178:126-34. doi: 10.1016/j.ahj.2016.05.007. Epub 2016 May 17.
Derived from this study: PubMed 42015174Cai Y, Yang Q, Quan X, Lang X, Yu L, Yang Y, Zhu J, Liang Y. Impact of left ventricular ejection fraction on left ventricular thrombus resolution. J Cardiothorac Surg. 2026 Apr 21;21(1):543. doi: 10.1186/s13019-026-04106-9.
Derived from this study: PubMed 36940069Yang Q, Quan X, Zhang Y, Feng G, Zhang T, Wang C, Yu D, Yu L, Yang Y, Zhu J, Liang Y. An exploratory study of effectiveness and safety of rivaroxaban in patients with left ventricular thrombus (R-DISSOLVE). J Thromb Thrombolysis. 2023 May;55(4):649-659. doi: 10.1007/s11239-023-02790-1. Epub 2023 Mar 20.
Individual participant dataSharing planned: Undecided

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 study testing Rivaroxaban in people with Ventricular Mural Thrombosis, run by China National Center for Cardiovascular Diseases at 1 site in China.

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 12 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 2 Aug 2024. 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 China. 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?

Yes. Results are posted in the registry (first posted 2 Aug 2024). 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?

Number of Participants With Left Ventricular Thrombus Resolution at 12 Weeks/Number of Participants at 12 Weeks (time frame: 12 weeks). 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 NCT04970381, which also lists 8 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 2 Aug 2024.