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Thrombolytic Agent
Thrombolysis Methods for Blood Clots in the Lung
Phase 4
Waitlist Available
Led By Azhar Supariwala, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PE symptom duration less than or equal to 14 days -
Submassive PE confirmed by right ventricular dimension to left ventricular dimension ratio ≥ 1 in apical 4-chamber view echo/CT scan.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial looks at two ways to treat people with a type of blood clot in the lung, to see which is better at improving heart function and reducing pressure in the lung arteries.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include bleeding complications due to alteplase, a medication used to break down blood clots; this can range from mild bruising to serious internal bleeding. The EKOS procedure may cause local pain, infection at the catheter site, or damage to blood vessels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My symptoms of pulmonary embolism have been present for 14 days or less.
Select...
My heart scan shows a specific type of lung clot.
Select...
I am 18 years or older and can give my consent.
Select...
My CT scan shows a large clot in the main lung artery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Mortality
Other study objectives
Pulmonary pressures
Right ventricle (RV) to Left ventricle (LV) ratio
Side effects data
From 2017 Phase 4 trial • 81 Patients • NCT0215952110%
Deep vein thrombosis
8%
Nausea
6%
Procedural haemorrhage
4%
Pain in extremity
4%
Back pain
3%
Pruritus
3%
Asthma
3%
Haematoma
3%
Anaemia
3%
Bradycardia
3%
Anxiety
3%
Contusion
3%
Haematuria
1%
Hypertension
1%
Pelvic venous thrombosis
1%
Lactic acidosis
1%
Blood fibrinogen decreased
1%
Constipation
1%
Dizziness
1%
Oxygen saturation decreased
1%
Upper gastrointestinal haemorrhage
1%
Sinusitis
1%
Epistaxis
1%
Migraine
1%
Drug hypersensitivity
1%
Insomnia
1%
Atrial fibrillation
1%
Haemoptysis
1%
Joint effusion
1%
Groin pain
1%
Pneumonia aspiration
1%
Post procedural haemorrhage
1%
Oedema
1%
Injection site haemorrhage
1%
Abdominal pain
1%
Uterine haemorrhage
1%
Rash
1%
Cardiac failure congestive
1%
Pulmonary embolism
1%
Ecchymosis
1%
Osteomyelitis
1%
Septic shock
1%
Haemorrhage
1%
Venous occlusion
1%
Hypoaesthesia
1%
Dyspnoea
1%
Ventricular extrasystoles
1%
Urinary tract infection
1%
Heparin-induced thrombocytopenia
1%
Skin ulcer
1%
Dysuria
1%
Squamous cell carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
EkoSonic® Endovascular System
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Peripheral low dose thrombolysisExperimental Treatment1 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 thrombolysisActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alteplase
2006
Completed Phase 4
~7400
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,103 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
30 Patients Enrolled for Pulmonary Embolism
Azhar Supariwala, MD5.02 ReviewsPrincipal Investigator - Southside Northwell Hospital
Northwell Health
5Patient Review
Bedside manner is amazing. Excellent doctor.