The primary objective of this study is to evaluate safety and initial effectiveness of DS-9231 when taken together with current standard of care. Evaluation will be done with low, medium and then high doses of DS-9231 versus placebo, in participants with medium-risk acute pulmonary embolism.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Percent change from baseline in total thrombus volume
Time frame: Baseline, 48-96 hours after study drug administration
Percentage of participants with various gradations of decrease in total thrombus volume
Time frame: Baseline, 48-96 hours after study drug administration
Number of participants with major or clinically relevant nonmajor bleeding
Time frame: within 7 days after study drug administration
Number of participants with adverse events
Time frame: within 30 days after study drug administration
Percent change from baseline in total thrombus volume
Time frame: Baseline, 30 days after study drug administration
Percentage of participants with with various gradations of decrease in total thrombus volume
Time frame: 30 days after study drug administration
Percent change from baseline in RV/ left ventricle (LV) diameter ratio
Time frame: Baseline, 48-96 hours and 30 days after study drug administration
Number of participants with PE-related deaths
Time frame: within 30 days after study drug administration
Number of participants who died from any cause
Time frame: within 30 days after study drug administration
Percentage of participants with clinical deterioration requiring additional rescue therapy for PE
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Time frame: within 30 days after study drug administration
Number of participants with with recurrent, objectively documented venous thromboembolism (VTE)
Time frame: within 30 days after study drug administration
Participant-reported quality of life on a proprietary scale
Time frame: Baseline, Day 30 after study drug administration
Number of participants with major or clinically relevant nonmajor bleeding
Time frame: within 30 days after study drug administration
Number of participants re-hospitalized for any reason
Time frame: within 30 days after study drug administration
Number of participants with non-bleeding adverse events (AEs)
Time frame: within 30 days after study drug administration
Number of participants with anti-drug antibodies (ADAs)
Time frame: within 30 days after study drug administration
Plasma concentration of DS-9231
Time frame: Baseline to 30 days after study drug administration