Thrombolysis Methods for Blood Clots in the Lung

Not currently recruiting at 1 trial location

Overseen By Azhar Supariwala, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Northwell Health

Must not be taking: Thrombolytics, Vitamin K antagonists

Disqualifiers: Bleeding disorders, Hypertension, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12-24 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to dissolve blood clots in the lungs, known as pulmonary embolisms (PEs), using the drug Alteplase, a thrombolytic or clot-dissolving medication. It compares a newer method that uses sound waves to guide the drug directly to the clot with a traditional method that delivers the drug through regular IV infusion in the arm. Researchers aim to determine if the traditional method is as effective as the new one. Individuals who have recently experienced a submassive PE, confirmed by a CT scan, and have had symptoms for less than 14 days might be suitable for this trial. As a Phase 4 trial, this research helps understand how the already FDA-approved and effective treatment benefits more patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have taken thrombolytic drugs in the last 4 days, you cannot participate.

What is the safety track record for these treatments?

Research has shown that Alteplase, used in both treatment methods, safely breaks down blood clots. It is often used to treat strokes and heart attacks. Although bleeding can occur with Alteplase, this is expected and aligns with its known safety profile.

For the catheter-directed method using the EKOS system, studies have found it safe and effective. It typically results in little blood loss and minimal injury. Patients often experience long-term improvements in heart function.

Both methods have been used in other conditions and are well-researched, indicating they are generally safe for treating blood clots in the lungs. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatment methods for blood clots in the lungs, which typically involve systemic thrombolysis, these trial methods focus on targeted delivery of medication. Catheter-directed acoustic thrombolysis uses a special catheter system to deliver alteplase directly into the blood clot, potentially increasing effectiveness while minimizing side effects. Meanwhile, peripheral low dose thrombolysis uses a more traditional intravenous approach but at a lower dose, which might reduce bleeding risks. Researchers are excited because these methods promise more precise treatment with potentially better outcomes and fewer complications.

What evidence suggests that this trial's treatments could be effective for submassive pulmonary embolism?

Research shows that catheter-directed thrombolysis, such as the EKOS system, effectively improves heart function and reduces complications in patients with pulmonary embolism (PE). In this trial, one group of participants will receive this treatment. Studies indicate it enhances the function of the right side of the heart and lowers pressure in the lung arteries, with a low risk of bleeding. Another group in this trial will receive a low dose of the medication alteplase, administered peripherally. Research has shown that this method is also effective for treating PE, helping improve heart and lung function. Strong evidence supports both methods for managing submassive PE, demonstrating their effectiveness in dissolving blood clots in the lungs. ^{2 3 6 7 8}

Who Is on the Research Team?

Azhar Supariwala, MD

Principal Investigator

Southside Northwell Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a condition called submassive pulmonary embolism (PE), which involves blood clots in the lungs causing heart issues. Participants must have specific signs of heart strain and be within two weeks of PE symptom onset. Those with minor or resolved symptoms, or other health conditions that could interfere are not eligible.

Inclusion Criteria

My symptoms of pulmonary embolism have been present for 14 days or less.

Signs of RV dysfunction by echocardiogram, or elevated troponin I >0.04, or pro-BNP > 400 on serial measurements.

My heart scan shows a specific type of lung clot.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either peripheral low dose systemic thrombolysis (PLST) or catheter directed acoustic pulse thrombolysis (ACDT) for submassive pulmonary embolism

12-24 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measurements of RV:LV ratio and pulmonary pressures

30 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Alteplase
• EKOS

Trial Overview The study compares two treatments for breaking up blood clots in the lungs: peripheral low dose systemic thrombolysis (PLST) using drugs to dissolve clots throughout the body, versus catheter directed acoustic pulse thrombolysis (ACDT) targeting clot areas directly. It aims to see if PLST is just as effective as ACDT at improving heart function and lowering lung artery pressure.

How Is the Trial Designed?

Group I: Peripheral low dose thrombolysis Experimental Treatment 1 Intervention

Peripheral low dose thrombolysis will use a peripheral vein into an arm as in routine intravenous therapy. This is the experimental arm. Alteplate (R-tpa) belong to thrombolytic or fibrnolytic drug class. Routine hospital policies for peripheral venous therapy will be used. A fixed dose of 24 mg of Activase (Atleplase) over 12 hours or 2.0 mg/hr will be administered peripherally. Simultaneously, intravenous unfractionated heparin will be given with a target partial thromboplastin time of 40 to 60 secs.

Group II: Catheter directed acoustic thrombolysis Active Control 1 Intervention

For ACDT, routine hospital protocols and EKOS(generic) will be used. EKOS is made up of 3 parts which include the drug delivery pulmonary artery catheter, a removable microsonic device, and a reusable Eko-Sonic control unit. Venous access will be obtained by ultrasound guidance in the internal jugular vein or femoral vein. After catheter placement, the right heart pressures will be measured. R-tpa will be directly given into the pulmonary catheter. A fixed dose of 24 mg of tpa over 12 hours or 2.0mg/hr will be given. For unilateral PE, a single catheter will be used with infusion rate of 2 mg//hr and two catheters will be used for bilateral PEs each with 1 mg /hr infusion rate. Intravenous unfractionated heparin will be given with a target partial thromboplastin time of 40 to 60 secs.

Alteplase is already approved in United States, European Union for the following indications:

Approved in United States as Activase for:

• Acute ischemic stroke
• Acute myocardial infarction
• Pulmonary embolism
• Blocked central venous catheter

Approved in European Union as Actilyse for:

• Acute ischemic stroke
• Acute myocardial infarction
• Pulmonary embolism
• Blocked central venous catheter

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK536918/

Catheter-Directed Thrombolysis of Pulmonary Embolism - NCBI This minimally invasive technique, delivering thrombolytic agents directly to the clot via catheterization, promises targeted therapy with potentially reduced ...

2. jscai.org jscai.org/article/S2772-9303(25)01154-8/fulltext

The EKOS-PE Study The EKOS therapy is associated with significant long-term improvement in RV function, low mortality, and favorable perceived QoL, supporting its use in massive ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.123.013448

Prospective Multicenter International Registry of ... A multicenter international registry designed to study the treatment of acute PE with USCDT, with focus on safety outcomes.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0049384823000889

Clinical outcomes of ultrasound-assisted coagulation ... Ultrasound-assisted catheter-directed thrombolysis (USAT) may reverse right ventricular dysfunction due to acute pulmonary embolism (PE) with a favorable safety ...

5. bostonscientific.com bostonscientific.com/us/en/healthcare-professionals/products/thrombectomy-systems/ekos-endovascular-system/fp00000423.html

EKOS™ Endovascular System EKOS is a safe, repeatable and reliable treatment that dissolves thrombus quickly with low lytic, low blood loss and low trauma – resulting in proven long-term ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12462068/

The EKOS-PE Study - PMC - PubMed Central The EKOS therapy is associated with significant long-term improvement in RV function, low mortality, and favorable perceived QoL, supporting its use in massive ...

7. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.113.005544

Randomized, Controlled Trial of Ultrasound-Assisted ... In patients with acute pulmonary embolism, systemic thrombolysis improves right ventricular (RV) dilatation, is associated with major ...

8. jcvaonline.com jcvaonline.com/article/S1053-0770(21)00882-X/fulltext

Evolving Management Trends and Outcomes in Catheter ... This technique involves using 4/5-Fr catheters, such as Uni-Fuse, that are advanced within a pulmonary thrombus under fluoroscopic guidance.