Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 6 Weeks/Number of Participants at 6 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences & Pecking Union Medical College | Beijing | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22986555 | Background | 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. | |
| 23247304 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rivaroxaban | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rivaroxaban | Rivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 12 weeks |
|
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rivaroxaban | Rivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rehospitalization | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy causing rivaroxaban discontinuation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Yan Liang | Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College | +8618801287180 | fwyy2803@163.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2020 | Mar 5, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2020 | Mar 5, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| 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 | 12 weeks |
| 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. |
| 28886621 | Background | 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. |
| 15842354 | Background | 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. |
| 28844192 | Background | 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. |
| 27502860 | Background | 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. |
| 42015174 | Derived | 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. doi: 10.1186/s13019-026-04106-9. Online ahead of print. |
| 36940069 | Derived | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI, kg/m2 | Mean | Standard Deviation | kg/m2 |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 2 |
| 75 |
| 7 |
| 75 |
| 1 |
| 75 |
Not provided
Not provided
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |