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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2024-11-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial with 1:1:1 allocation to treatment strata

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Primary endpoint will be assessed by assessor blinded to the intervention

Study Groups

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USAT + low dose thrombolysis

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

Group Type ACTIVE_COMPARATOR

Alteplase 20 Mg Powder for Solution for Injection Vial

Intervention Type DRUG

Low dose alteplase delivered IV or bu Ultrasound Assisted Thrombolysis device

Ultrasound assisted Thrombolysis

Intervention Type DEVICE

Ultrasound assisted thrombolysis (USAT)

Low dose thrombolysis

Intravenous low dose thrombolysis (20 mg of rtPA, Alteplase) over 6 hours plus UFH or low molecular weight heparin (LMWH).

Group Type ACTIVE_COMPARATOR

Alteplase 20 Mg Powder for Solution for Injection Vial

Intervention Type DRUG

Low dose alteplase delivered IV or bu Ultrasound Assisted Thrombolysis device

Heparin alone

UFH or low molecular weight heparin (LMWH) only (with option for conventional thrombolysis according to local protocols for hemodynamic deterioration)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Alteplase 20 Mg Powder for Solution for Injection Vial

Low dose alteplase delivered IV or bu Ultrasound Assisted Thrombolysis device

Intervention Type DRUG

Ultrasound assisted Thrombolysis

Ultrasound assisted thrombolysis (USAT)

Intervention Type DEVICE

Eligibility Criteria

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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

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

1. Hemorrhagic stroke or stroke of unknown origin at any time
2. Ischemic stroke in the preceding 6 months
3. Central nervous system damage or neoplasms
4. Recent major trauma/surgery/head injury in the preceding 3 weeks
5. Gastrointestinal bleeding within the last month
6. Known bleeding risk

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No