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Pulmonary EmbolismPhase 3STRATIFYNCT04088292

Low Dose Thrombolysis, Ultrasound Assisted Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism

A Phase 3 study testing Alteplase 20 Mg Powder for Solution for Injection Vial and Ultrasound assisted Thrombolysis in people with Pulmonary Embolism, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Open label clinical randomized trial comparing three strategies for managing acute intermediate-high risk pulmonary embolism Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism
What is being tested?
Alteplase 20 Mg Powder for Solution for Injection Vial and Ultrasound assisted Thrombolysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
4 sitesDenmark
Study dates
6 Jun 2019to 30 Nov 2024
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Informed consent for trial participation
  • Intermediate high-risk PE according to ESC criteria
  • Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography
  • 14 days of symptoms or less

Who cannot join

  • Altered mental state (GCS < 14)
  • No qualifying CT angiography performed (> 24 hour since CT angiography)
  • Females of child bearing potential, unless negative HCG test is present
  • Thrombolysis for PE within 14 days of randomization
  • Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism)
  • Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed)
Show all 14Show fewer
  • Comorbidity making 6 months survival unlikely
  • Absolute contraindications for thrombolysis
  • Hemorrhagic stroke or stroke of unknown origin at any time
  • Ischemic stroke in the preceding 6 months
  • Central nervous system damage or neoplasms
  • Recent major trauma/surgery/head injury in the preceding 3 weeks
  • Gastrointestinal bleeding within the last month
  • Known bleeding risk

Trial locations and contacts

4 sites in 1 country.

Denmark4 sites

  • Copenhagen University Hospital Bispebjerg Hospital

    Bispebjerg, DK2400

  • Copenhagen University Hospital Rigshospitalet

    Copenhagen, DK2100

  • Copenhagen University Hospital Gentofte

    Gentofte Municipality, Capital Region, 2900

  • Copenhagen University Hospital, Herlev Gentofte Hospital

    Herlev, DK2730

Other trials in Denmark

About this study

Open label clinical randomized trial comparing three strategies for managing acute intermediate-high risk pulmonary embolism

Read the detailed description

Trial acronym: STRATIFY Background: Intermediate-high risk pulmonary embolism (PE) is associated with a significant risk of death or hemodynamic deterioration. The optimal treatment strategy should balance efficacy in reducing thrombus burden and hemodynamic compromise with risk of complications, in particular bleeding. Previous studies have investigated conventional high-dose, short term thrombolysis by (rtPA), finding a reduction in risk hemodynamic deterioration, but no reduction in mortality and a substantial increase in significant bleeding complications.

Catheter based techniques and low dose thrombolysis may offer lower risk of complication with reasonable efficacy. Such studies have not been performed in RCTs with a reasonable sample size, and no study have compared low dose intravenous thrombolysis and catheter based techniques.

The current trial addresses this paucity of data by randomizing patients to one of three treatment modalities:

Intervention: 1:1:1 randomization, stratified for site to

  • UltraSound Assisted Thrombolysis (USAT) with low dose thrombolysis (20 mg of rtPA, Alteplase) over 6 hours plus unfractionated heparin (UFH) or low molecular weight heparin (LMWH) within 12 hours of randomization
  • Intravenous low dose thrombolysis (20 mg of rtPA, Alteplase) over 6 hours plus UFH or low molecular weight heparin (LMWH).
  • UFH or low molecular weight heparin (LMWH) only (with option for conventional thrombolysis according to local protocols for hemodynamic deterioration) Design: Regional collaborative, randomized trial with 1:1:1 allocation of 210 patients with acute intermediate-high risk PE with no absolute contraindications to thrombolysis
Being tested
Alteplase 20 Mg Powder for Solution for Injection Vial, Ultrasound assisted Thrombolysis
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alteplase 20 Mg Powder for Solution for Injection VialDrug

    Low dose alteplase delivered IV or bu Ultrasound Assisted Thrombolysis device

  • Ultrasound assisted ThrombolysisDevice

    Ultrasound assisted thrombolysis (USAT)

Study groups in NCT04088292
Study groupRoleWhat they receive
USAT + low dose thrombolysisActive comparatorUltraSound Assisted Thrombolysis (USAT) with low dose thrombolysis (20 mg of rtPA, Alteplase) over 6 hours plus unfractionated heparin (UFH) or low molecular weight heparin (LMWH) within 12 hours of randomization
Receives: Drug: Alteplase 20 Mg Powder for Solution for Injection Vial; Device: Ultrasound assisted Thrombolysis
Low dose thrombolysisActive comparatorIntravenous low dose thrombolysis (20 mg of rtPA, Alteplase) over 6 hours plus UFH or low molecular weight heparin (LMWH).
Receives: Drug: Alteplase 20 Mg Powder for Solution for Injection Vial
Heparin aloneNo interventionUFH or low molecular weight heparin (LMWH) only (with option for conventional thrombolysis according to local protocols for hemodynamic deterioration)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in Miller score comparing low dose thrombolysis and heparin alone groups

    Reduction in Miller Score and on follow-up (48-96 h) CT pulmonary Angiography comparing low-dose rtPA (±USAT) to UFH/LMWH group (p<0.01, N=210)

    Measured: at 48 to 96 hours post randomization

  2. Reduction i Miller score comparing low dose thrombolysis by iv and by USATgroups

    reduction in Miller Score and on follow-up (48-96 h) CT pulmonary Angiography comparing low-dose rtPA by USAT to iv, p<0.04, N=140)

    Measured: at 48 to 96 hours post randomization

Secondary outcomes (9)

  1. Incidence of bleeding complications

    Bleeding complications (major and minor bleeding complication according the TIMI classification)

    Measured: Until hospital discharge, on average 1 week

  2. Length of stay of index admission

    Duration of index admission, including hospital based rehabilitation

    Measured: End of study, expected to be 5 years

  3. Dyspnea index by visual analogue scale

    Dyspnea index (Visual analog scale) after 48-96 h and after 3 months

    Measured: End of study, expected to be 5 years

  4. Change in oxygen supplement (FiO2)

    FiO2 (in %)

    Measured: at 48 to 96 hours post randomization

  5. Mortality rate

    Mortality in the three groups (log-rank), and hazard ratio in multivariable analysis using the UFH/LMWH as reference

    Measured: End of study, expected to be 5 years

  6. Incidence of Pulmonary Hypertension

    Incidence of TR gradient > 40 mmHg at 3 months follow-up echocardiography

    Measured: 3 months follow-up

  7. 6 minute walk distance af follow-up

    6 minute walk distance at 3 months follow-up visit

    Measured: 3 months follow-up

  8. Health related Quality of Life (PEmb-QoL)

    Health related Quality of Life at 3 months follow-up using PEmb-QoL (Pulmonary Embolism Quality of Life) ranging from 0 to 100, higher score indicating worse Quality of Life

    Measured: 3 months follow-up

  9. Health related Quality of Life (EQ-5D-5L)

    5Q-5D-5L (EuroQoL 5 dimension, 5 level questionnaire, ranging from -0.59 to 1, where 1 is the best possible health state)

    Measured: 3 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2019
  2. Study start6 Jun 2019
  3. Primary completion5 Jun 2024
  4. Study completion30 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized clinical trial with 1:1:1 allocation to treatment strata
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04088292
Sponsor's protocol ID
STRATIFY-1
Acronym
STRATIFY
Status last verified
Nov 2024
First submitted
9 Sep 2019
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Undecided: Main trial database

Publications

  • Kjaergaard J, Bang LE, Sonne-Holm E, Wiberg S, Holmvang L, Lassen JF, Sorensen R, Hofsten DE, Ulriksen PS, Jawad S, Palm P, Soe C, Ersboll MK, Boesgaard S, Moller JE, Thune JJ, Hassager C, Tilsted HH, Lonborg J, Egstrup M, Kristiansen OP, Seven E, Lindholm MG, Eskesen K, Fano S, Carlsen J. Randomized trial of low-dose, ultrasound-assisted thrombolysis or heparin for pulmonary embolism. Cardiovasc Res. 2026 Mar 26;122(4):539-549. doi: 10.1093/cvr/cvag038.

    PubMed 41610160

  • Kjaergaard J, Carlsen J, Sonne-Holm E, Wiberg S, Holmvang L, Lassen JF, Sorensen R, Hofsten D, Ulriksen PS, Jawad S, Palm P, Thune JJ, Hassager C, Kristiansen OP, Eskesen K, Fano S, Bang LE. A randomized trial of low-dose thrombolysis, ultrasound-assisted thrombolysis, or heparin for intermediate-high risk pulmonary embolism-the STRATIFY trial: design and statistical analysis plan. Trials. 2024 Dec 28;25(1):853. doi: 10.1186/s13063-024-08688-4.

    PubMed 39732696

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alteplase 20 Mg Powder for Solution for Injection Vial and Ultrasound assisted Thrombolysis in people with Pulmonary Embolism, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Miller score comparing low dose thrombolysis and heparin alone groups (time frame: at 48 to 96 hours post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04088292, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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