What side effects are associated with this type of intervention?

The most common treatments for pulmonary embolism, such as anticoagulation therapy and catheter-directed thrombolysis, have several known side effects. Anticoagulation therapy can lead to bleeding complications, including gastrointestinal bleeding and intracranial hemorrhage. Catheter-directed thrombolysis, which enhances clot dissolution by delivering thrombolytic drugs directly to the clot, can also cause bleeding, particularly at the puncture site, and may result in complications such as infection, vessel damage, or embolization of clot fragments.

What prior FDA approvals exist?

The FDA has approved several treatments for pulmonary embolism (PE) that enhance clot dissolution in combination with anticoagulation. One such treatment is catheter-directed thrombolysis, which involves the use of a catheter to deliver thrombolytic drugs directly to the site of the clot. Devices like the EkoSonicTM Endovascular System, which uses ultrasound to enhance the delivery and efficacy of thrombolytic agents, are also being studied for their effectiveness in treating PE. These treatments aim to improve outcomes by more effectively dissolving clots while minimizing the risk of bleeding associated with systemic thrombolysis.

What other types of research exist?

Promising, novel alternatives to the EkoSonicTM Endovascular device for pulmonary embolism patients include catheter-directed thrombolysis (CDT) with ultrasound facilitation, mechanical thrombectomy devices, and advanced pharmacomechanical thrombolysis systems. These methods aim to enhance clot dissolution and improve clinical outcomes in PE patients.

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Anticoagulant

Catheter-directed Thrombolysis for Pulmonary Embolism (HI-PEITHO Trial)

Phase 4

Recruiting

Led By Stavros Konstantinides, MD

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-80 years, inclusive

Objectively confirmed acute PE, based on computed tomography pulmonary angiography (CTPA) showing a filling defect in at least one main or proximal lobar pulmonary artery

Must not have

History of intracranial or intraocular bleeding at any time

Chronic treatment with antiplatelet agents other than low-dose acetylsalicylic acid or clopidogrel 75 mg once daily (but not both). Dual antiplatelet therapy is excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial compares two treatments for blood clots in the lungs in patients at higher risk of complications. One treatment uses only blood thinners, while the other combines blood thinners with a device that uses sound waves to break up clots. The goal is to see which treatment is better at reducing serious problems and death.

Who is the study for?

Adults aged 18-80 with a recent diagnosis of acute pulmonary embolism, at elevated risk of early death or hemodynamic collapse, but not in shock or needing intensive care for other reasons. They must have certain clinical signs like increased heart rate and specific blood test results. Excluded are those who've had major bleeding issues, strokes, certain surgeries recently, severe infections like COVID-19 if it's not the main issue, pregnant women, and people on some chronic medications.

What is being tested?

The HI-PEITHO study is testing two treatments for pulmonary embolism: standard anticoagulation therapy alone versus anticoagulation plus the EkoSonicTM Endovascular System to break up clots. Participants will be randomly assigned to one of these treatments and monitored over a year through several follow-ups to see which treatment reduces death and complications more effectively.

What are the potential side effects?

Possible side effects include bleeding risks associated with heparin use (like bruising or nosebleeds), potential allergic reactions to device materials or medication excipients used in the trial interventions. The endovascular system might also cause local irritation where it's inserted.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have a confirmed pulmonary embolism shown by a CT scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had bleeding in my brain or eyes at some point.

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I only take low-dose aspirin or clopidogrel for my chronic condition, not both.

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I am currently experiencing active bleeding.

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I have not had a cardiac arrest or needed CPR recently.

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I have had a stroke or mini-stroke in the last 6 months, or any time before that which left me permanently disabled.

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I have a brain tumor or cancer that has spread to my brain.

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I am on a long-term blood thinner like apixaban or rivaroxaban.

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I have taken apixaban or rivaroxaban within the last 12 hours.

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I am on chronic vitamin K treatment or have a blood clotting disorder with an INR > 1.5.

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I have experienced shock due to a pulmonary embolism, with low blood pressure and signs of poor organ function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cardiorespiratory decompensation or collapse

PE recurrence

PE-related mortality

Other study objectives

All-cause mortality

All-cause mortality, cardiorespiratory collapse or recurrence of PE

Change from baseline in RV dysfunction on echocardiography

+12 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Anticoagulation and EkoSonicTM Endovascular SystemActive Control2 Interventions

Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH) and EkoSonicTM Endovascular System \[ultrasound-facilitated catheter-directed delivery of thrombolytic: 2 mg bolus/catheter + 1 mg/hour/catheter for 7 hours (total of 9 or 18 mg\]

Group II: AnticoagulationActive Control1 Intervention

Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pulmonary Embolism (PE) include anticoagulation and thrombolysis. Anticoagulation therapy, such as with heparin or warfarin, prevents further clot formation and allows the body's natural fibrinolytic system to break down the existing clot. Thrombolysis involves the use of drugs like tissue plasminogen activator (tPA) to actively dissolve clots. The EkoSonicTM Endovascular device enhances this process by using ultrasound waves to facilitate the penetration of thrombolytic agents into the clot, improving the efficiency of clot dissolution. This combination is crucial for PE patients as it can rapidly reduce the clot burden, improve blood flow, and decrease the risk of complications such as right heart failure and death.