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

Primary Purpose

Ventricular Mural Thrombosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rivaroxaban
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Mural Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients over 18 years old;
  2. 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;
  3. Patients who received standard anticoagulant therapy for less than 4 weeks before enrollment did not use antiplatelet drugs or only used single antiplatelet drugs;
  4. The patients voluntarily joined the study and signed the informed consent.

Exclusion Criteria:

  1. Patients with contraindications to rivaroxaban anticoagulation therapy;
  2. Patients with a history of acute pulmonary embolism or deep venous thrombosis within a week need intensive anticoagulant therapy;
  3. Patients with history of hemorrhagic stroke within one week;
  4. Patients with cardiac benign and malignant tumors;
  5. Aspirin and P2Y12 receptor antagonists should be kept;
  6. 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;
  7. The patient's history of intracerebral hemorrhage and active hemorrhage was 8 months;
  8. Patients with hematological diseases, hemoglobin < 100g / L, platelet < 80 x 10^9 / L;
  9. Women with pregnancy status, planned pregnancy and lactation period;
  10. Patients with life expectancy less than 1 year;
  11. Patients enrolled in other clinical studies;
  12. 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.

Sites / Locations

  • Fuwai Hospital, Chinese Academy of Medical Sciences & Pecking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rivaroxaban

Arm Description

Outcomes

Primary Outcome Measures

Thrombus resolution rate
The left ventricular thrombus resolution rate at 12 weeks

Secondary Outcome Measures

Thrombus resolution rate
The left ventricular thrombus resolution rate at 6 weeks
Thrombus resolution or reduction rate
The left ventricular thrombus resolution or reduction rate at 6 weeks
Thrombus resolution or reduction rate
The left ventricular thrombus resolution or reduction rate at 12 weeks

Full Information

First Posted
July 11, 2021
Last Updated
June 24, 2022
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT04970381
Brief Title
An Exploratory stuDy of effectIveneSs and Safety of rivarOxaban in Patients With Left VEntricular Thrombus (R-DISSOLVE)
Acronym
R-DISSOLVE
Official Title
An Exploratory Study of Effectiveness and Safety of Rivaroxaban in Patients With Left Ventricular Thrombus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Mural Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Intervention Description
Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks
Primary Outcome Measure Information:
Title
Thrombus resolution rate
Description
The left ventricular thrombus resolution rate at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Thrombus resolution rate
Description
The left ventricular thrombus resolution rate at 6 weeks
Time Frame
6 weeks
Title
Thrombus resolution or reduction rate
Description
The left ventricular thrombus resolution or reduction rate at 6 weeks
Time Frame
6 weeks
Title
Thrombus resolution or reduction rate
Description
The left ventricular thrombus resolution or reduction rate at 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Qing, Master
Email
www.sunnydog1028@163.com
Facility Information:
Facility Name
Fuwai Hospital, Chinese Academy of Medical Sciences & Pecking Union Medical College
City
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Liang

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22986555
Citation
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Results Reference
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Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
15842354
Citation
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.
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Citation
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.
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An Exploratory stuDy of effectIveneSs and Safety of rivarOxaban in Patients With Left VEntricular Thrombus (R-DISSOLVE)

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