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Thrombolytic Agent

Alteplase for Pulmonary Embolism

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

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.

Eligible Conditions
  • Pulmonary Embolism
  • Pulmonary Hypertension
  • Blood Clot
  • Right Ventricular Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 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
Mortality
Other study objectives
Pulmonary pressures
Right ventricle (RV) to Left ventricle (LV) ratio

Side effects data

From 2017 Phase 4 trial • 81 Patients • NCT02159521
10%
Deep vein thrombosis
8%
Nausea
6%
Procedural haemorrhage
4%
Pain in extremity
4%
Back pain
3%
Anaemia
3%
Haematoma
3%
Pruritus
3%
Asthma
3%
Bradycardia
3%
Anxiety
3%
Contusion
3%
Haematuria
1%
Joint effusion
1%
Constipation
1%
Insomnia
1%
Lactic acidosis
1%
Hypertension
1%
Haemorrhage
1%
Oxygen saturation decreased
1%
Sinusitis
1%
Atrial fibrillation
1%
Epistaxis
1%
Ecchymosis
1%
Injection site haemorrhage
1%
Migraine
1%
Blood fibrinogen decreased
1%
Pneumonia aspiration
1%
Abdominal pain
1%
Haemoptysis
1%
Groin pain
1%
Oedema
1%
Urinary tract infection
1%
Upper gastrointestinal haemorrhage
1%
Uterine haemorrhage
1%
Post procedural haemorrhage
1%
Cardiac failure congestive
1%
Dizziness
1%
Drug hypersensitivity
1%
Pulmonary embolism
1%
Heparin-induced thrombocytopenia
1%
Pelvic venous thrombosis
1%
Osteomyelitis
1%
Septic shock
1%
Rash
1%
Venous occlusion
1%
Hypoaesthesia
1%
Dyspnoea
1%
Ventricular extrasystoles
1%
Skin ulcer
1%
Dysuria
1%
Squamous cell carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
EkoSonic® Endovascular System

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
~7120

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
473 Previous Clinical Trials
472,231 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.
~5 spots leftby Oct 2025
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