What side effects are associated with this type of intervention?

Thrombolytic therapy, used to dissolve blood clots in pulmonary embolism, commonly causes bleeding complications, which can range from minor to life-threatening hemorrhages. Other potential side effects include allergic reactions, hypotension, and reperfusion arrhythmias. Due to these serious side effects, thrombolytic therapy is generally reserved for high-risk patients where the benefits are deemed to outweigh the risks.

What prior FDA approvals exist?

The FDA has approved several thrombolytic agents for the treatment of pulmonary embolism, which work by dissolving blood clots. Notable drugs include alteplase (tPA), which is commonly used in acute settings to rapidly break down clots. Other thrombolytics like reteplase and tenecteplase have also been approved for similar indications. These agents are typically administered in emergency situations to improve blood flow and reduce the risk of severe complications associated with pulmonary embolism.

What other types of research exist?

Promising novel alternatives to thrombolytic therapy for pulmonary embolism patients include the use of catheter-directed therapies, which deliver clot-dissolving agents directly to the site of the clot, reducing systemic exposure and potential side effects. Another alternative is mechanical thrombectomy, which physically removes the clot using specialized devices. Additionally, novel anticoagulants and targeted therapies, such as direct oral anticoagulants (DOACs) and factor Xa inhibitors, are being explored for their efficacy in preventing clot progression and recurrence with potentially fewer side effects.

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Thrombolytic Agent

Reduced-Dose Thrombolytic Therapy for Pulmonary Embolism (PEITHO-3 Trial)

Phase 3

Recruiting

Led By Guy Meyer, MD

Research Sponsored by Assistance Publique - Hôpitaux de Paris

Eligibility Criteria Checklist

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

Must have

Age 18 years or older

Right ventricular dysfunction indicated by RV/LV diameter ratio >1.0 on echocardiography apical four-chamber or subcostal four-chamber view or on Computed Tomography Pulmonary Angiography (transverse plane)

Must not have

Recent use of specific anticoagulants

Known central nervous system neoplasm/metastasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Awards & highlights

Pivotal Trial

Summary

This trial tests a smaller dose of a clot-busting drug combined with a blood thinner in patients with serious lung clots. The goal is to see if this approach is effective and safer than higher doses, reducing the risk of severe bleeding.

Who is the study for?

This trial is for adults with a recent acute pulmonary embolism, at elevated risk of early death or recurrence. They must have right ventricular dysfunction and raised serum troponin levels. Exclusions include history of brain bleeding, certain drug treatments, recent surgeries or trauma, severe liver disease, uncontrolled hypertension, and women who are pregnant or not using birth control.

What is being tested?

The study tests if a reduced dose of Alteplase (thrombolytic therapy) plus low-molecular-weight heparin is effective and safe in patients with intermediate-high-risk acute pulmonary embolism compared to placebo. Participants are randomly assigned to receive either the treatment or placebo.

What are the potential side effects?

Alteplase may cause bleeding complications including intracranial hemorrhage, gastrointestinal bleeding, allergic reactions such as rash or swelling around the eyes and lips; it can also lead to reperfusion arrhythmias when blood flow returns after being blocked.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My heart's right ventricle is not functioning properly, as shown by imaging tests.

Exclusion Criteria

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

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I have recently used blood thinners.

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

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My blood pressure is not well-controlled.

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I have had bleeding in my brain not caused by injury.

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I am taking medication to prevent blood clots.

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I have recently been given medication to break up blood clots.

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I recently had a procedure to insert a filter in my vein or remove a clot from my lung.

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I have a known issue with my blood vessels, like an aneurysm.

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My blood pressure and heart rate are not stable.

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I am a woman able to have children and am not using birth control.

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I have been diagnosed with pericarditis or endocarditis.

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I have severe liver disease or acute pancreatitis.

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I am currently experiencing active bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Composite of the primary efficacy endpoint and GUSTO severe or life-threatening bleeding

Utilization of health care ressources

Side effects data

From 2017 Phase 4 trial • 81 Patients • NCT02159521

10%

Deep vein thrombosis

Nausea

Procedural haemorrhage

Pain in extremity

Back pain

Pruritus

Asthma

Haematoma

Anaemia

Bradycardia

Anxiety

Contusion

Haematuria

Lactic acidosis

Blood fibrinogen decreased

Constipation

Dizziness

Oxygen saturation decreased

Upper gastrointestinal haemorrhage

Sinusitis

Epistaxis

Migraine

Drug hypersensitivity

Insomnia

Atrial fibrillation

Hypertension

Haemoptysis

Joint effusion

Pulmonary embolism

Groin pain

Post procedural haemorrhage

Oedema

Injection site haemorrhage

Abdominal pain

Uterine haemorrhage

Rash

Cardiac failure congestive

Ecchymosis

Pneumonia aspiration

Osteomyelitis

Septic shock

Haemorrhage

Venous occlusion

Hypoaesthesia

Dyspnoea

Ventricular extrasystoles

Urinary tract infection

Heparin-induced thrombocytopenia

Pelvic venous thrombosis

Skin ulcer

Dysuria

Squamous cell carcinoma

100%

80%

60%

40%

20%

Study treatment Arm

EkoSonic® Endovascular System

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AlteplaseExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alteplase

2006

Completed Phase 4

~7400

0 / 15Eligibility 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

Thrombolytic therapy, such as the use of recombinant tissue-type plasminogen activator (tPA), works by dissolving blood clots that obstruct pulmonary arteries, thereby restoring normal blood flow and oxygenation in the lungs. This is crucial for patients with Pulmonary Embolism (PE) as it can significantly reduce the risk of severe complications or death. Additionally, anticoagulants like low-molecular-weight heparin and direct oral anticoagulants (DOACs) are used to prevent further clot formation, ensuring that the initial clot does not worsen and that new clots do not develop.