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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
PEITHO-3 Trial Summary
This trial will test whether a reduced dose of thrombolytic therapy, given with low-molecular-weight heparin, is effective and safe in patients with intermediate-high-risk acute pulmonary embolism.
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.Check my eligibility
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.See study design
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.
PEITHO-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My heart's right ventricle is not functioning properly, as shown by imaging tests.
PEITHO-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of (1) death from any cause or (2) hemodynamic decompensation or (3) objectively confirmed recurrent PE.
Secondary outcome measures
All-cause mortality
Composite of the primary efficacy endpoint and GUSTO severe or life-threatening bleeding
Confirmed chronic thromboembolic pulmonary hypertension
+11 moreSide 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%
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
PEITHO-3 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
~7390
Find a Location
Who is running the clinical trial?
Boehringer IngelheimIndustry Sponsor
2,507 Previous Clinical Trials
11,340,222 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
1,005 Patients Enrolled for Pulmonary Embolism
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,452,767 Total Patients Enrolled
6 Trials studying Pulmonary Embolism
8,784 Patients Enrolled for Pulmonary Embolism
Instituto de Salud Carlos IIIOTHER_GOV
296 Previous Clinical Trials
636,469 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high chance of experiencing severe health problems or a blood clot coming back, based on specific criteria.I have recently used blood thinners.I have a brain tumor or cancer that has spread to my brain.I have not had surgery or experienced trauma in the last 3 weeks.I am 18 years old or older.Your platelet count is less than 100,000 per microliter.You have had a previous allergic reaction to heparin that caused low platelet count.You have been diagnosed with a blood clot in your lungs within the past 24 hours before joining the study.You are not expected to live for more than 6 months, or you cannot finish the 6-month check-ups.I have had stomach ulcers or esophageal varices in the last 3 months.My blood pressure is not well-controlled.I have had bleeding in my brain not caused by injury.I am taking medication to prevent blood clots.I have recently been given medication to break up blood clots.I recently had a procedure to insert a filter in my vein or remove a clot from my lung.I had a stroke or a mini-stroke in the last 6 months.You have been diagnosed with a blood clot in your lungs within the past two weeks.I have a known issue with my blood vessels, like an aneurysm.You are at risk of serious bleeding.You have a specific heart condition shown by certain imaging tests.Your blood test shows high levels of troponin I or T using a sensitive assay.My blood pressure and heart rate are not stable.Your blood takes longer than usual to clot.You are allergic to certain medications.I am a woman able to have children and am not using birth control.I have been diagnosed with pericarditis or endocarditis.I have severe liver disease or acute pancreatitis.I am currently experiencing active bleeding.My heart's right ventricle is not functioning properly, as shown by imaging tests.
Research Study Groups:
This trial has the following groups:- Group 1: Alteplase
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the potential risks associated with Alteplase?
"Alteplase is generally considered safe due to its efficacy in past clinical trials and the large amount of safety data that has been collected."
Answered by AI
Are we still enrolling patients for this clinical trial?
"The trial is currently active and recruiting patients, with the most recent update being on May 2nd, 2022. The clinical study was first posted online on August 4th, 2021."
Answered by AI
Are there other examples of Alteplase being used in a medical setting?
"Alteplase is being studied in 23 different active clinical trials, 16 of which are Phase 3. The majority of research facilities for Alteplase are located in Hollywood, Florida; however, there are a total of 419 sites running trials worldwide."
Answered by AI
Is this study popular among North American hospitals?
"There are 8 sites enrolling patients in this study, such as Hamilton Health Sciences Corporation in Hamilton, Hamilton Health Sciences and St Jospeh's Hospital Hamilton in Montréal, and Jewish General Hospital in Calgary."
Answered by AI
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