Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism

Completed · Phase 4

Conditions studied: Pulmonary Embolism and Thrombosis

In brief

The objective is to determine the optimum dose of thrombolytic and duration of the ultrasound procedure (together defined as the APT Procedure) as a treatment for acute submassive pulmonary embolism (PE). Symptomatic submassive PE are participants with acute (less than or equal to \[≤\]14 days) PE with normal systemic arterial blood pressure (greater than \[\>\] 90 mmHg) and evidence of RV dysfunction (right ventricular to left ventricular diameter ratio, that is; RV/LV ratio greater than or equal to \[≥\] 0.9). Participants with submassive PE will be randomized to one of four APT treatment groups: ultrasound of 2 and 6 hours (hrs) with r-tPA 2 milligrams (mg)/hr/catheter and ultrasound 4 and 6 hours with r-tPA, 1 mg/hr/catheter. On 08 June 2016, randomization into treatment group 4 (APT/6 hours-r-tPA/2 mg/hr/catheter) was closed following a reported intracranial hemorrhage (ICH) and death in a study participant in this arm.

Key facts

Study ID

NCT02396758

Run by

Boston Scientific Corporation

People needed

131

Starts

2015-06-12

Expected to finish

2020-01-30

Last updated by the study team

2021-07-19

Who can join

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

You may qualify if…

• Male or female greater than or equal to (≥) 18 years of age and less than or equal to (≤) 75 years of age.
• CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery).
• PE symptom duration ≤14 days.
• Submassive PE: RV/LV diameter ≥ 0.9 from CTA and hemodynamically stable. For Participants in UK Sites: Submassive PE: RV/LV diameter ≥ 0.9 from CTA, hemodynamically stable and an elevated biomarker.
• Must be treated within 48 hours of diagnosis of PE by CTA.
• Signed Informed consent obtained from subject or Legally Authorized Representative.

You may not qualify if…

• 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 seven days of screening for study enrollment.
• Clinician deems the subject high-risk for catastrophic bleeding.
• History of heparin-induced thrombocytopenia (HIT).
• Catheter-based pharmacomechanical treatment for PE within 3 days of study enrollment.
• Systolic blood pressure (SBP) less than 90 mm Hg and/or use of vasopressors.
• Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR).
• Evidence of irreversible neurological compromise.
• Life expectancy < one year. For Participants in UK Sites: Life expectancy < one year or enrollment in hospice care.
• Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study.
• Out-of-Range Laboratory Values: Hematocrit < 30%, Platelets < 100 thousand/microliter (μL), International normalized ratio (INR) > 3.
• Creatinine outside the normal range for the treating institution.
• Participant is pregnant (positive pregnancy test; women of childbearing capacity must be tested) or breast feeding.
• Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: participants with non-melanoma primary skin cancers are eligible to participate in the study.
• Known allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or iodinated contrast except for mild-moderate contrast allergies for which steroid pre-medication can be used.
• History of any hematologic disease potentially involving abnormal platelet number or function.

Where it is running

• Cedars Sinai — Beverly Hills, California, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• Florida Hospital Tampa — Tampa, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• University Hospital — Augusta, Georgia, United States
• St. Vincent Medical Group — Indianapolis, Indiana, United States
• Jewish Hospital — Louisville, Kentucky, United States
• East Jefferson General Hospital — Metairie, Louisiana, United States
• Detroit Medical Center — Detroit, Michigan, United States
• Mount Carmel Health System — Columbus, Ohio, United States
• UPMC Hamot — Erie, Pennsylvania, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Houston Methodist Sugarland Hospital — Richmond, Texas, United States
• Inova Alexandria Hospital — Alexandria, Virginia, United States
• Providence Sacred Heart Medical Center — Spokane, Washington, United States
• Royal Devon & Exeter Hospital — Exeter, England, United Kingdom
• Medway Maritime Hospital — Gillingham, England, United Kingdom
• Royal Free Hospital — London, England, United Kingdom
• St. Thomas Hospital — London, England, United Kingdom
• Ninewells Hospital — Dundee, Scotland, United Kingdom

Full record on ClinicalTrials.gov

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