Stratify Ii

2024-515712-45-00 Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 4 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 210
Countries 1
Sites 4

Pulmonary embolism

The STRATIFY II trial investigates the efficacy of three different approaches to reducing thrombus burden in patients with acute intermediate high-risk pulmonary embolism: percutaneous embolectomy (the Flow Triever® system, INARI medical or The AlphaVac® system, Angiodynamics), loww dose (10 mg ov over 6 hours) altepla…

Key facts

Sponsor
Rigshospitalet
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Decision date (initial)
2024-10-18
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The STRATIFY II trial investigates the efficacy of three different approaches to reducing thrombus burden in patients with acute intermediate high-risk pulmonary embolism: percutaneous embolectomy (the Flow Triever® system, INARI medical or The AlphaVac® system, Angiodynamics), loww dose (10 mg ov over 6 hours) alteplase and heparin with the option to perform full-dose thrombolysis. As a co-primary secondary endpoint, the trial assesses the incremental efficacy of the embolectomy versus the catheter-based low dose thrombolysis approach.

Conditions and MedDRA coding

Pulmonary embolism

VersionLevelCodeTermSystem organ class
21.0 PT 10037377 Pulmonary embolism 100000004855

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Age ≥ 18 years
  2. Intermediate high-risk pulmenary embolism according to ESC criteria
  3. Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography
  4. 14 days of symptoms or less, with significant worsening of symptoms within 7 days
  5. Class II risk assessed by the Pulmonary Embolism Severity Index

Exclusion criteria 8

  1. Altered mental state (GCS < 14)
  2. No qualifying CT angiography performed (> 24 hour since CT angiography)
  3. Women of childbearing 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. History of haemorrhagic stroke or stroke of unknown origin b. Ischaemic stroke in previous 6 months c. Central nervous system neoplasm d. Major trauma, surgery, or head injury in previous 3 weeks a. Bleeding diathesis – Active bleeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous treated groups (embolectomy and USAT combined) to heparin/LMWH group (n=140 versus n=70)
  2. Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous embolectomy and USAT (n=70 versus n=70)

Secondary endpoints 8

  1. Bleeding complications (major and minor bleeding complication according the TIMI classification)
  2. Duration of index admission, including hospital-based rehabilitation
  3. Dyspnoea index (Visual analogue scale) after 48-96 h and after 3 months
  4. Rate of further interventions for pulmonary embolism during admission (embolectomy, full dose thrombolysis, mechanical ventilation, need for vasopressors, cardiopulmonary resuscitation, VA-ECMO etc.)
  5. Mortality in the three arms (log-rank), and hazard ratio in multivariable analysis using the UFH/LMWH as reference.
  6. Incidence of tricuspid regurgitation (TR) gradient > 40 mmHg at 3 months follow-up echocardiography
  7. Six-minute walking distance (6MWD) at 3 months follow-up comparing the three groups
  8. Quality of life (PEmbQoL) at 3 months follow-up comparing the three groups

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Actilyse 10 mg powder and solvent for solution for injection and infusion

PRD355835 · Product

Active substance
Alteplase
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INFUSION
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
B01AD02 — ALTEPLASE
Marketing authorisation
PL 14598/0183
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Heparin

SCP100373670 · ATC

Active substance
Heparin
Substance synonyms
HEPARIINI, HEPARINUM
Route of administration
INFUSION
Max daily dose
60000 IU international unit(s)
Max total dose
120000 IU international unit(s)
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
B01AB01 — HEPARIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

Tinzaparin Sodium

SCP125024106 · ATC

Active substance
Tinzaparin Sodium
Route of administration
INFUSION
Max daily dose
175 IU/kg international unit(s)/kilogram
Max total dose
1050 IU/kg international unit(s)/kilogram
Max treatment duration
6 Day(s)
Authorisation status
Authorised
ATC code
B01AB10 — TINZAPARIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

94 Total trials 54 Recruiting 24 Ended
Academic / Non-commercial
Sponsor organisation
Rigshospitalet
Address
Blegdamsvej 9
City
Copenhagen Oe
Postcode
2100
Country
Denmark

Scientific contact point

Organisation
Rigshospitalet
Contact name
Jesper Kjærgaard

Public contact point

Organisation
Rigshospitalet
Contact name
Jesper Kjærgaard

Third parties 3

OrganisationCity, countryDuties
Odense University Hospital
ORG-100007716
 Odense C, Denmark On site monitoring
Aalborg University Hospital
ORG-100022335
 Aalborg, Denmark On site monitoring
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Locations

1 EU/EEA country · 4 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Authorised, recruitment pending 210 4
Rest of world — 0 —

Investigational sites

Denmark

4 sites · Authorised, recruitment pending
Odense University Hospital
Cardiology, J. B. Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Cardiology, Blegdamsvej 9, 2100, Copenhagen Oe
Aalborg University Hospital
Cardiology, Hobrovej 18-22, 9000, Aalborg
Hvidovre Hospital
Cardiology, Kettegaard Alle 36, 2650, Hvidovre

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-515712-45-00 4.1
Protocol (for publication) D1_Protocol 2024-515712-45-00 TC 4.1
Protocol (for publication) D4_Patient facing documents Questionnaire BFI 1
Protocol (for publication) D4_Patient facing documents Questionnaire EQ-5D-5L 1
Protocol (for publication) D4_Patient facing documents Questionnaire PE dyspn score 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 2
Recruitment arrangements (for publication) K1_Recruitment arrangements TC 2
Subject information and informed consent form (for publication) L1_ICF Right not to know 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults 4.1
Subject information and informed consent form (for publication) L2_Other subject information material Data protection 1
Subject information and informed consent form (for publication) L2_Other subject information material Participant rights 1
Summary of Product Characteristics (SmPC) (for publication) G2_SMPC Actilyse 1
Summary of Product Characteristics (SmPC) (for publication) G2_SMPC heparin UFH 1
Summary of Product Characteristics (SmPC) (for publication) G2_SMPC Innohep LMWH 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-08-06 Denmark Acceptable
2024-10-18
 2024-10-18
2 SUBSTANTIAL MODIFICATION SM-1 2026-02-04 Denmark Acceptable
2026-03-13
 2026-03-13

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