Comparing three different treatment options for acute clots in the pulmonary vessels

Phase 1

• Conditions: Acute Pulmonary Embolism, intermediate high risk (visible impact on right ventricular structure and function, and biochemical markers og myocardial damage according to the European Society of Cardiology Guidelines); MedDRA version: 21.0Level: PTClassification code 10037377Term: Pulmonary embolismSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-005075-91-DK
• Lead Sponsor: Copenhagen University Hospital Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-25
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1)Age = 18 years
2)Informed consent for trial participation
3)Intermediate high-risk PE according to ESC criteria
4)Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography
5)14 days of symptoms or less

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1)Altered mental state (GCS < 14)
2)No qualifying CT angiography performed (> 24 hour since CT angiography)
3)Females of child bearing potential, unless negative HCG test is present
4)Thrombolysis for PE within 14 days of randomization
5)Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism)
6)Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed)
7)Comorbidity making 6 months survival unlikely
8)Absolute contraindications for thrombolysis
a.Hemorrhagic stroke or stroke of unknown origin at any time
b.Ischemic stroke in the preceding 6 months
c.Central nervous system damage or neoplasms
d.Recent major trauma/surgery/head injury in the preceding 3 weeks
e. Gastrointestinal bleeding within the last month
f.Known bleeding risk
Relative contraindications do not preclude randomization. Relative contraindications include: Transient ischemic attack in the preceding 6 months, Oral anticoagulant therapy, Pregnancy, or within one week pPost partum, Non-compressible puncture site, Traumatic resuscitation, Refractory hypertension (systolic blood pressure >180 mm Hg), Advanced liver disease, Infective endocarditis, Active peptic ulcer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified