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Completed

NCT Number: NCT04970381

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, 100037, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Participants With Left Ventricular Thrombus Resolution at 6 Weeks/Number of Participants at 6 Weeks

    Time frame: 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

  2. Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 6 Weeks/Number of Participants at 6 Weeks

    Time frame: 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

  3. Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 12 Weeks/Number of Participants at 12 Weeks

    Time frame: 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

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Acronym: R-DISSOLVE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2021
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.