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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

Study 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Mortality
Other outcome measures
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%
Bradycardia
3%
Asthma
3%
Haematoma
3%
Anaemia
3%
Haematuria
3%
Pruritus
3%
Contusion
3%
Anxiety
1%
Upper gastrointestinal haemorrhage
1%
Dyspnoea
1%
Pulmonary embolism
1%
Osteomyelitis
1%
Urinary tract infection
1%
Epistaxis
1%
Joint effusion
1%
Abdominal pain
1%
Dizziness
1%
Uterine haemorrhage
1%
Post procedural haemorrhage
1%
Oedema
1%
Groin pain
1%
Skin ulcer
1%
Migraine
1%
Blood fibrinogen decreased
1%
Cardiac failure congestive
1%
Venous occlusion
1%
Heparin-induced thrombocytopenia
1%
Atrial fibrillation
1%
Septic shock
1%
Oxygen saturation decreased
1%
Rash
1%
Haemoptysis
1%
Constipation
1%
Sinusitis
1%
Haemorrhage
1%
Dysuria
1%
Hypoaesthesia
1%
Insomnia
1%
Drug hypersensitivity
1%
Squamous cell carcinoma
1%
Hypertension
1%
Pneumonia aspiration
1%
Lactic acidosis
1%
Ecchymosis
1%
Injection site haemorrhage
1%
Pelvic venous thrombosis
1%
Ventricular extrasystoles
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
~7390

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,902 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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Alteplase been authorized by the FDA?

"According to our experts at Power, Alteplase is believed to be safe and has been assigned a rating of 3. This medication has already passed through Phase 4 trials, suggesting it's achieved approval status."

Answered by AI

What is the capacity of subjects who are able to partake in this research project?

"This clinical trial has closed its recruitment process. The original posting was on January 28th 2019 and the last update happened April 4th 2022. For those searching for new trials, there are currently 269 studies admitting patients with ventricular dysfunction and 22 administering alteplase actively recruiting participants."

Answered by AI

Does this research permit the participation of individuals younger than 25 years?

"According to the study's inclusion criteria, 18-89 year olds are eligible for enrollment. There are 35 trials specifically targeting participants under 18 and 264 studies recruiting those over 65 years old."

Answered by AI

What kind of participants is this research team looking for?

"This clinical trial seeks 31 individuals, aged 18 to 89, who have been diagnosed with ventricular dysfunction. In order to participate in the study they must also possess: Symptoms of RV impairment detected by echocardiogram or an elevated troponin I >0.04 or pro-BNP>400 on serial measurements; The capacity for informed consent; Submassive PE revealed through CT scan imaging displaying saddle pulmonary embolism, central right and/or left main pulmonary artery emboli.; Confirmed submassive PE with a ratio of Right Ventricular Dimension (RVD) to Left Ventricle Dimension (LVD) ≥1"

Answered by AI

Could you elaborate on previous experiments involving Alteplase?

"At present, there are 22 studies conducted for Alteplase, 15 of which are at Phase 3. Most trials occur in Hollywood, Florida; nevertheless, overall 418 locations disperse the medication."

Answered by AI

Is enrollment in this trial occurring presently?

"The recruitment phase for this clinical trial has concluded. The study was initially posted on the 28th of January 2019, and updated lastly on April 4th 2022. For those desiring to participate in similar trials, there are presently 269 studies searching for individuals with ventricular dysfunction, plus an additional 22 recruiting participants that require Alteplase treatment."

Answered by AI
Recent research and studies
The American Journal of MedicineJournal
Deep Vein Thrombosis and Pulmonary Embolism in Two Cohorts: The Longitudinal Investigation of Thromboembolism Etiology
Cushman, Mary, Albert W Tsai, Richard H White, Susan R Heckbert, Wayne D Rosamond, Paul Enright, and Aaron R Folsom. 2004. “Deep Vein Thrombosis and Pulmonary Embolism in Two Cohorts: The Longitudinal Investigation of Thromboembolism Etiology”. The American Journal of Medicine. Elsevier BV. doi:10.1016/j.amjmed.2004.01.018.
CirculationJournal
Randomized, Controlled Trial of Ultrasound-assisted Catheter-directed Thrombolysis for Acute Intermediate-risk Pulmonary Embolism
Kucher, Nils, Peter Boekstegers, Oliver J. Müller, Christian Kupatt, Jan Beyer-Westendorf, Thomas Heitzer, Ulrich Tebbe, et al.. 2014. “Randomized, Controlled Trial of Ultrasound-assisted Catheter-directed Thrombolysis for Acute Intermediate-risk Pulmonary Embolism”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.113.005544.
Arteriosclerosis, Thrombosis, and Vascular BiologyJournal
Influence of Γ′ Fibrinogen Splice Variant on Fibrin Physical Properties and Fibrinolysis Rate
Collet, J.P., C. Nagaswami, D.H. Farrell, G. Montalescot, and J.W. Weisel. 2004. “Influence of Γ′ Fibrinogen Splice Variant on Fibrin Physical Properties and Fibrinolysis Rate”. Arteriosclerosis, Thrombosis, and Vascular Biology. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/01.atv.0000109748.77727.3e.
Thrombosis ResearchJournal
Bolus Tenecteplase for Right Ventricle Dysfunction in Hemodynamically Stable Patients with Pulmonary Embolism
Becattini, Cecilia, Giancarlo Agnelli, Aldo Salvi, Stefano Grifoni, Leonardo Goffredo Pancaldi, Iolanda Enea, Franco Balsemin, Mauro Campanini, Angelo Ghirarduzzi, and Franco Casazza. 2010. “Bolus Tenecteplase for Right Ventricle Dysfunction in Hemodynamically Stable Patients with Pulmonary Embolism”. Thrombosis Research. Elsevier BV. doi:10.1016/j.thromres.2009.09.017.
~5 spots leftby Apr 2025
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