Pulmonary EmbolismPhase 3STEPNCT03966079
Thrombolysis Endovascular Treatment of Pulmonary Embolism
A Phase 3 study testing recombinant tissue plasminogen activator in people with Pulmonary Embolism and Acute Pulmonary Embolism, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
To assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Acute Pulmonary Embolism
- What is being tested?
- recombinant tissue plasminogen activator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Jan 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- CT evidence of proximal PE
- Age ≥ 18 years
- Pulmonary embolism symptom duration ≤14 days
- Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) OR Submassive PE (RV diameter-to-LV diameter ≥ 0.9 on contrast-enhanced chest CT)
Who cannot join
- Age <18 years
- PE symptom duration >14 days
- Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
- Recent (within one month) or active bleeding from a major organ
- Pregnancy
- Chronic pulmonary hypertension or severe chronic obstructive pulmonary disease
Show all 10Show fewer
- Administration of thrombolytic agents within the previous 3 days
- Life expectancy < 30 days
- Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
- Inability to follow protocol requirements
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, 102218
About this study
Official title: Single-dose rtPA Thrombolysis Endovascular Treatment of Pulmonary Embolism With Right Ventricular Dysfunction:a Pilot Study
To assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA
Read the detailed description
The patients with right ventricular dysfunction who are diagnosed by CT pulmonary angiography will receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the in this study. The Change of RV to LV Diameter Ratio,Rate of death,rate of major bleeding,pulmonary embolism recurrence at 1month will be reviewed to assess the efficacy and safety.
- Conditions
- Pulmonary Embolism, Acute Pulmonary Embolism
- Being tested
- recombinant tissue plasminogen activator
- Keywords
- Acute Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant tissue plasminogen activatorDrug
Also called rtPA
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter Receives: Drug: recombinant tissue plasminogen activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of RV to LV Diameter Ratio
Determine whether single-dose rtpa catheter-directed thrombolysis decrease the ratio of right ventricular (RV)-to-left ventricular (LV) diameter within 1month in patients with right ventricular dysfunction
Measured: baseline and 30days after baseline
Secondary outcomes (3)
Rate of death
Measured: 30days
Rate of major Bleeding
Measured: 30days
Pulmonary embolism recurrence
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jan 2017
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wu weiwei, doctor, Study director, Director of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966079
- Sponsor's protocol ID
- BeijingTCGH
- Acronym
- STEP
- Status last verified
- Nov 2020
- First submitted
- 20 May 2019
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose rtPA Thrombolysis Endovascular Treatment of Pulmonary Embolism With Right Ventricular Dysfunction:a Pilot Study
- ClinicalTrials.gov ID
- NCT03966079
- Acronym / sponsor ID
- STEP / BeijingTCGH
- Conditions
- Pulmonary Embolism, Acute Pulmonary Embolism
- Keywords
- Acute Pulmonary Embolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA
Detailed description
The patients with right ventricular dysfunction who are diagnosed by CT pulmonary angiography will receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the in this study. The Change of RV to LV Diameter Ratio,Rate of death,rate of major bleeding,pulmonary embolism recurrence at 1month will be reviewed to assess the efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Drug: recombinant tissue plasminogen activatorPatients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CT evidence of proximal PE
- Age ≥ 18 years
- Pulmonary embolism symptom duration ≤14 days
- Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) OR Submassive PE (RV diameter-to-LV diameter ≥ 0.9 on contrast-enhanced chest CT)
Key exclusion criteria (10 listed)
- Age <18 years
- PE symptom duration >14 days
- Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
- Recent (within one month) or active bleeding from a major organ
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant tissue plasminogen activatorAlso: rtPAPatients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter | Drug | Intervention arm |
Primary outcome
Change of RV to LV Diameter Ratio
Time frame: baseline and 30days after baseline
Determine whether single-dose rtpa catheter-directed thrombolysis decrease the ratio of right ventricular (RV)-to-left ventricular (LV) diameter within 1month in patients with right ventricular dysfunction
3 secondary outcomes
Rate of death
Time frame: 30days
Rate of major Bleeding
Time frame: 30days
Pulmonary embolism recurrence
Time frame: 30days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wu weiwei, doctor study director
Director of department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing recombinant tissue plasminogen activator in people with Pulmonary Embolism and Acute Pulmonary Embolism, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of RV to LV Diameter Ratio (time frame: baseline and 30days after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2020.