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

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Recruiting
CT.gov ID
NCT04970381
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
29.3
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Exploratory Study of Effectiveness and Safety of Rivaroxaban in Patients With Left Ventricular Thrombus
Actual Study Start Date :
Jul 22, 2021
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rivaroxaban

Drug: Rivaroxaban
Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks

Outcome Measures

Primary Outcome Measures

  1. Thrombus resolution rate [12 weeks]

    The left ventricular thrombus resolution rate at 12 weeks

Secondary Outcome Measures

  1. Thrombus resolution rate [6 weeks]

    The left ventricular thrombus resolution rate at 6 weeks

  2. Thrombus resolution or reduction rate [6 weeks]

    The left ventricular thrombus resolution or reduction rate at 6 weeks

  3. Thrombus resolution or reduction rate [12 weeks]

    The left ventricular thrombus resolution or reduction rate at 12 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fuwai Hospital, Chinese Academy of Medical Sciences & Pecking Union Medical College Beijing China 100037

Sponsors and Collaborators

  • China National Center for Cardiovascular Diseases

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT04970381
Other Study ID Numbers:
  • FW-2020-1380
First Posted:
Jul 21, 2021
Last Update Posted:
Jun 29, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Thrombosis
Rivaroxaban

Study Results

No Results Posted as of Jun 29, 2022