Pulmonary Embolism
Conditions
Keywords
Sub-massive acute pulmonary embolism
Brief summary
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.
Interventions
DRUGDS-9231
DS-9231 in saline solution for intravenous infusion
DRUGPlacebo
Placebo is matching saline solution for intravenous infusion
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Ascending doses in sequential cohorts (1-3) will be evaluated against placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Had protocol-defined pulmonary embolism (PE) * Has stable systolic blood pressure (SBP) \>90 mm Hg * Has evidence of right ventricular (RV) dysfunction * Has executed informed consent
Exclusion criteria
* Has history or plans for thrombotic therapy outside protocol allowance * Has other contraindications for participation * Has laboratory results outside protocol-specified limits * Is pregnant, nursing, and/or not willing or able to use protocol-defined contraceptives * Has history or condition, or participated in another investigational study that (per protocol or in the opinion of the investigator) might compromise: 1. the safety or well-being of the participant or the participant's offspring 2. the safety of study staff 3. the analysis of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in total thrombus volume | Baseline, 48-96 hours after study drug administration |
| Percentage of participants with various gradations of decrease in total thrombus volume | Baseline, 48-96 hours after study drug administration |
| Number of participants with major or clinically relevant nonmajor bleeding | within 7 days after study drug administration |
| Number of participants with adverse events | within 30 days after study drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants who died from any cause | within 30 days after study drug administration |
| Percentage of participants with clinical deterioration requiring additional rescue therapy for PE | within 30 days after study drug administration |
| Number of participants with with recurrent, objectively documented venous thromboembolism (VTE) | within 30 days after study drug administration |
| Participant-reported quality of life on a proprietary scale | Baseline, Day 30 after study drug administration |
| Percent change from baseline in total thrombus volume | Baseline, 30 days after study drug administration |
| Number of participants re-hospitalized for any reason | within 30 days after study drug administration |
| Number of participants with non-bleeding adverse events (AEs) | within 30 days after study drug administration |
| Number of participants with anti-drug antibodies (ADAs) | within 30 days after study drug administration |
| Plasma concentration of DS-9231 | Baseline to 30 days after study drug administration |
| Number of participants with major or clinically relevant nonmajor bleeding | within 30 days after study drug administration |
| Percentage of participants with with various gradations of decrease in total thrombus volume | 30 days after study drug administration |
| Percent change from baseline in RV/ left ventricle (LV) diameter ratio | Baseline, 48-96 hours and 30 days after study drug administration |
| Number of participants with PE-related deaths | within 30 days after study drug administration |
Outcome results
None listed