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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

Summary

This trial will compare two ways of treating pulmonary embolism, by either using blood thinners or a device to dissolve blood clots.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cardiorespiratory decompensation or collapse
PE recurrence
PE-related mortality
Other outcome measures
All-cause mortality
All-cause mortality, cardiorespiratory collapse or recurrence of PE
Cardiorespiratory decompensation
+18 more

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)

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.

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
724 Previous Clinical Trials
933,579 Total Patients Enrolled
9 Trials studying Pulmonary Embolism
2,126 Patients Enrolled for Pulmonary Embolism
University Medical Center MainzOTHER
20 Previous Clinical Trials
37,036 Total Patients Enrolled
National PERT Consortium, Inc.UNKNOWN

Media Library

Anticoagulation with heparin (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04790370 — Phase 4
Pulmonary Embolism Research Study Groups: Anticoagulation and EkoSonicTM Endovascular System, Anticoagulation
Pulmonary Embolism Clinical Trial 2023: Anticoagulation with heparin Highlights & Side Effects. Trial Name: NCT04790370 — Phase 4
Anticoagulation with heparin (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04790370 — Phase 4
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