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Tests treatment safety and results for Pulmonary Embolism Acute
Official title Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients
ClinicalTrials.gov ID: NCT06487052
What this study is testing
What is Standard Catheter-Directed Low Dose Thrombolysis?
Standard Catheter-Directed Low Dose Thrombolysis is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pulmonary embolism acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A single-center, open-label, randomized comparative study of two treatment strategies in patients with intermediate-high-risk acute pulmonary embolism (PE). Patients will be randomized in a 1:1 ratio to standard anticoagulant therapy or standard catheter-directed thrombolysis (SСDT) with a low dose of alteplase, followed by evaluation of short- and long-term efficacy and safety in each group
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18 years
- Computed tomography angiography (CTA) - verified proximal (pulmonary trunk and/or main and/or lobar branches of the pulmonary artery) PE and symptom...
- Intermediate-high risk PE with a RV dysfunction (RV/LV diameter ratio \>1 on TTE or CTA) and an elevated biomarker (hs-troponin or NT-proBNP) level
- Signed informed consent
You likely can't join if
- High-risk pulmonary embolism
- Thrombus in the heart chambers on TTE
- Absolute contraindications for the use of thrombolytic therapy: history of hemorrhagic stroke or stroke of unknown etiology; ischemic stroke or...
- Haemoglobin level \< 70 g/L, platelet count ≤ 100 x 109
- Allergic to alteplase or UFH or contrast allergy
- Pregnant or breastfeeding
See the full eligibility criteria
- Age \> 18 years
- Computed tomography angiography (CTA) - verified proximal (pulmonary trunk and/or main and/or lobar branches of the pulmonary artery) PE and symptom onset \< 14 days prior
- Intermediate-high risk PE with a RV dysfunction (RV/LV diameter ratio \>1 on TTE or CTA) and an elevated biomarker (hs-troponin or NT-proBNP) level
- Signed informed consent
- High-risk pulmonary embolism
- Thrombus in the heart chambers on TTE
- Absolute contraindications for the use of thrombolytic therapy: history of hemorrhagic stroke or stroke of unknown etiology; ischemic stroke or transient ischemic attack within the last 6 months; extensive bleeding...
- Haemoglobin level \< 70 g/L, platelet count ≤ 100 x 109
- Allergic to alteplase or UFH or contrast allergy
- Pregnant or breastfeeding
- Clinically significant malignancies
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.