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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Pulmonary Embolism With Acute Cor Pulmonale, Pulmonary Embolism, Pulmonary Embolism With Pulmonary Infarction, Pulmonary Embolism Subacute Massive, Right Ventricular Dysfunction, Right Ventricular Failure

In brief

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.

Key facts

Study ID

NCT03988842

Run by

Victor Tapson, MD

People needed

4

Starts

2019-07-25

Expected to finish

2020-04-05

Last updated by the study team

2021-06-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chest CT angiogram (CTA) evidence of proximal Pulmonary Embolism (PE) with a filling defect in at least one main pulmonary artery or lobar artery
• PE symptom duration ≤14 days
• Intermediate-high risk PE: defined as RV dysfunction with an RV/LV diameter ≥ 0.9, sPESI > 0, and either troponin > 0.05ng/mL or BNP > 100 pg/mL, and hemodynamically stable (systolic blood pressure > 90mmHg without the use of vasopressor support)
• Randomization within 24 + 4 hours of anticoagulation
• Signed and dated informed consent obtained from subject or legally authorized representative before initiation of any study procedures

You may not qualify if…

• Weight > 130kg or < 40 kg on day of randomization
• Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
• Recent (within one month) or active bleeding from a major organ
• Major surgery within 14 days
• Clinician deems the subject too high-risk for bleeding using HAS-BLED criteria
• History of any hematologic disease or coagulopathy
• Cirrhosis (as determined by Child-Pugh B or C)
• History of heparin-induced thrombocytopenia (HIT)
• Hemodynamic instability defined as systolic blood pressure (SBP) less than 90mmHg and/or use of vasopressors for greater than 15 minutes
• Severe hypertension as defined as SBP greater than 180mmHg
• Cardiac arrest or active cardiopulmonary resuscitation (CPR)
• Receiving neuraxial anesthesia or undergoing spinal puncture
• Patient with prosthetic heart valves
• Evidence of irreversible neurological compromise
• Evidence of poor functional status
• History of major gastrointestinal bleed within the last month
• Active gastric or duodenal ulcers
• Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to diagnosis
• Lovenox administration within 12 hours of randomization
• Direct-acting oral anticoagulant use (dabigatran, rivaroxaban, apixaban, or edoxaban) with last known dose within 48 hours
• Hemoglobin < 10 g/dL
• Creatinine clearances < 60 mL/min
• Platelets < 100 thousand/µL
• INR > 1.4
• Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 2 times upper limit of normal (ULN)

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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