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Clinical Trials/EUCTR2017-005075-91-DK
EUCTR2017-005075-91-DK
Active, Not Recruiting
Phase 1

OW DOSE THROMBOLYSIS, ULTRASOUND ASSISTED THROMBOLYSIS OR HEPARIN FOR INTERMEDIATE HIGH RISK PULMONARY EMBOLISM - STRATIFY

Copenhagen University Hospital Rigshospitalet0 sites210 target enrollmentMay 25, 2018
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ConditionsAcute 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 disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsActilyse

Overview

Phase
Phase 1
Intervention
Not specified
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)
Sponsor
Copenhagen University Hospital Rigshospitalet
Enrollment
210
Status
Active, Not Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 25, 2018
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Copenhagen University Hospital Rigshospitalet

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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