Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pu… (NCT03988842) | Clinical Trial Compass
TerminatedPhase 4
Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism
Stopped: COVID-19 pandemic
United States4 participantsStarted 2019-07-25
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 punc…
What they're measuring
1
Change in Extent of Clot Lysis in the Experimental Arm