Trial Outcomes & Findings for An Exploratory stuDy of effectIveneSs and Safety of rivarOxaban in Patients With Left VEntricular Thrombus (R-DISSOLVE) (NCT NCT04970381)

Last Updated: 2024-08-02

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

75 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-08-02

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	75
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rivaroxaban n=75 Participants Rivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks
Age, Continuous	50.3 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	75 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	75 participants n=5 Participants
BMI, kg/m2	24.5 kg/m2 STANDARD_DEVIATION 3.1 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Rivaroxaban n=64 Participants Rivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks
Number of Participants With Left Ventricular Thrombus Resolution at 12 Weeks/Number of Participants at 12 Weeks	50 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Rivaroxaban n=62 Participants Rivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks
Number of Participants With Left Ventricular Thrombus Resolution at 6 Weeks/Number of Participants at 6 Weeks	41 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Rivaroxaban n=62 Participants Rivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks
Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 6 Weeks/Number of Participants at 6 Weeks	59 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Rivaroxaban n=64 Participants Rivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks
Number of Participants With Left Ventricular Thrombus Resolution or Reduction at 12 Weeks/Number of Participants at 12 Weeks	61 Participants

Adverse Events

Rivaroxaban

Serious events: 7 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Rivaroxaban n=75 participants at risk Rivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks
Cardiac disorders Rehospitalization	9.3% 7/75 • 6 months

Other adverse events

Other adverse events
Measure	Rivaroxaban n=75 participants at risk Rivaroxaban: Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks
Skin and subcutaneous tissue disorders Allergy causing rivaroxaban discontinuation	1.3% 1/75 • 6 months

Additional Information

Prof. Yan Liang

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Phone: +8618801287180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place