Randomized Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism

Overview

About this study

This is a Phase 1b, double-blind (Principal Investigators, study subjects, Sponsor, Academic Research Organization ARO and Clinical Research Organization CRO blinded), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics PK, and pharmacodynamics PD of DS-1040b in subjects with acute submassive pulmonary embolism.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Male or female subjects, age 18 to 75 years admitted to hospital with a clinical diagnosis of acute PE categorized as low risk or intermediate-risk or submassive PE and for whom catheter-based therapy is not planned;
  • Subjects must have a CTA scan confirming the PE diagnosis and with at least one measurable index lesion in a segmental or larger pulmonary artery prior to randomization;
  • Subjects should be in otherwise satisfactory health in the opinion of the Investigator;
  • Subjects must be able to provide written informed consent.

Exclusion Criteria:

  • Subjects with acute PE categorized as high-risk or massive, or who are hemodynamically unstable, evidenced by a heart rate > 120 /min and a systolic blood pressure (SBP) of < 90 mmHg for more than 15 consecutive minutes or a drop in SBP of > 40 mmHg since presentation;
  • Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned;
  • Subjects with PE lesions only in the sub-segmental or smaller arteries;
  • Subjects receiving any vitamin K antagonists (VKAs) prior to randomization or receiving more than 36 hours treatment with LMW(low molecular weight Heparin) in therapeutic doses prior to randomization;
  • Subjects who had a prior intracranial hemorrhage, known arteriovenous malformation or aneurysm, head trauma, or evidence of active bleeding;
  • Subjects who within 48 hours of randomization have used an anti-Factor IIa agent such as dabigatran or an anti-FXa agent such as rivaroxaban, apixaban, or edoxaban;
  • Subjects who within 21 days prior to randomization have had gastrointestinal or genitourinary bleeding;
  • Subjects who within 14 days prior to randomization have had major surgery or a lumbar puncture (or epidural steroid injection);
  • Subjects with diagnosed active liver disease or with elevation of liver enzymes/bilirubin.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Sanjay Misra, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20391799

Mayo Clinic Footer