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Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism

NCT03988842 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-06-11

Study results available
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Summary

The purpose of this study is to examine the degree to which pulmonary embolism (clot) can be dissolved when treated with a very low dose of a systemic thrombolytic drug (clot buster) along with standard anticoagulant therapy as compared to the standard of care anticoagulant therapy alone.

Conditions

  • Pulmonary Embolism With Acute Cor Pulmonale
  • Pulmonary Embolism
  • Pulmonary Embolism With Pulmonary Infarction
  • Pulmonary Embolism Subacute Massive
  • Right Ventricular Dysfunction
  • Right Ventricular Failure

Interventions

DRUG

Alteplase

Lyophilized powder for reconstitution in 50mg vials

DRUG

Unfractionated heparin

Heparin sodium in 0.45% sodium chloride injection for intravenous use

DRUG

Placebo

Saline solution reconstituted to mimic Alteplase 50mg vial

DRUG

Apixaban

Apixaban tablet

Sponsors & Collaborators

Principal Investigators

  • Victor F Tapson, MD · Cedars-Sinai Medical Center

  • Aaron S Weinberg, MD · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-25
Primary Completion
2020-04-05
Completion
2020-04-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03988842 on ClinicalTrials.gov