Acute Pulmonary EmbolismPhase 2rPANCT04110275
Injection of Recombinant Human Tissue-type Plasminogen Activator Derivative for Acute Pulmonary Embolism(rPA)
A Phase 2 study testing Recombinant human tissue-type plasminogen activator derivative and Recombinant human tissue-type plasminogen activator in people with Acute Pulmonary Embolism, run by Angde Biotech Pharmaceutical Co., Ltd..
Trial summary
The purpose of this trial is to compare the efficacy and safety of Recombinant Human Tissue-Type Plasminogen Activator Derivative(rPA) and Recombinant Tissue-Type Plasminogen Activator(rt-PA) for the treatment of acute pulmonary embolism. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pulmonary Embolism
- What is being tested?
- Recombinant human tissue-type plasminogen activator derivative and Recombinant human tissue-type plasminogen activator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Aug 2021
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with high-risk acute pulmonary embolism: the main manifestations are shock and hypotension.Systemic systolic blood pressure <90 millimetre of mercury (mmHg) (1mmHg=0.133kPa), or a decrease from the base value ≥40 millimetre of mercury for more than 15min.
- Patients with moderate to high-risk acute pulmonary embolism who have worsened anticoagulant therapy require thrombolytic therapy:
- (Patients with moderate to high-risk acute pulmonary embolism: Right ventricular dysfunction (RVD) and elevated cardiac biomarkers coexist.)
- RVD diagnostic criteria: imaging evidence including echocardiography or CT:1) Ultrasound examination is consistent with the following performance: 1. right ventricular dilatation (right ventricular end-diastolic diameter / left ventricular end-diastolic diameter > 1.0 or 0.9); 2. right ventricular free wall movement amplitude decreased; 3. tricuspid regurgitation speed increased; 4. tricuspid annulus systolic displacement decreased (<17mm); 2) Computed Tomographic Pulmonary Angiography examination meets the following conditions: right ventricular dilatation (right ventricular end-diastolic diameter / left ventricular end-diastolic diameter > 1.0 or 0.9) found at the four-chamber heart level;
- Cardiac biological markers including N terminal pro B type natriuretic peptide (NT-proBNP/BNP) and troponin elevation;
- Diagnostic criteria for worsening after anticoagulant therapy in patients with moderate to high risk acute pulmonary embolism:
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- Hemodynamic deterioration (defined as meeting at least one of the following conditions: 1. requires cardiopulmonary resuscitation; 2. systemic systolic blood pressure <90 mmHg (1 mmHg = 0.133 kPa), or a decrease in basal value ≥ 40 mmHg for more than 15 min, or with terminal Low organ perfusion (limb cold or urine volume <30 ml/hr, or mental confusion); 3. need to infuse a booster drug (except dopamine <5 μg/kg/min) to maintain adequate tissue perfusion and systolic blood pressure > 90 mmHg ;
- The time from onset to the time of thrombolysis is ≤ 14 days;
- Male patients must agree to take effective contraceptive measures during treatment and at least 28 days after the end of the trial, and do not donate sperm during this period; women of childbearing age must be negative within the first 72 hours of randomization, and agree to adopt effective contraceptive measures during treatment and at least 28 days afterwards the last treatment.
- Voluntary signing of written informed consent form.
Who cannot join
- a history of hemorrhagic stroke or unexplained stroke;
- Ischemic stroke or transient ischemic attack within 3 months;
- Central nervous system damage or tumor;
- Surgery and trauma of the brain or spine within 2 months;
- Active internal bleeding within 1 month (such as gastrointestinal bleeding, hemoptysis, blood in the stool, etc.);
- High risk of bleeding: evidence or history of bleeding disorders, bleeding tendency, bleeding constitution or coagulopathy;
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- oral anticoagulant (can be randomized after a certain period of time, such as oral rivaroxaban can be randomized after 1 day of elution, oral warfarin can be performed at International Normalized Ratio <2.0 random);
- 1 week after pregnancy or delivery;
- vascular puncture of the site that cannot be oppressed;
- Cardiopulmonary resuscitation within 10 days;
- Hypertension that is difficult to control (systolic blood pressure > 180 mmHg and / or diastolic blood pressure ≥ 110 mmHg);
- Liver function is grade C of Child-Pugh ;
- Infective endocarditis;
- History of aneurysms or arteriovenous malformations, or suspected aortic dissection;
- Cardiac thrombosis;
- Diabetes with hemorrhagic retinopathy or other hemorrhagic eye diseases;
- Laboratory inspection:Platelets (PLT) <90×109/L;Alanine aminotransferase (ALT) > 2.5 × ULN, aspartate aminotransferase (AST) > 2.5 ×Upper Limit of Normal (ULN);Endogenous creatinine clearance (Ccr) ≤ 50ml/min (calculated according to the Cockcroft-Gault formula);Alkaline phosphatase (ALP) > 2.0 × ULN;
- Severe cardiac insufficiency occurred in the past 6 months, New York Heart Association Heart Function Rating (NYHA classification) ≥ III;
- Participate in other clinical trials within 1 month prior to enrollment;
- Known or suspected hypersensitivity to plasminogen activator, or allergic to contrast agents, or drugs administered during the trial;
- People with mental disorders;
- Accompanied by other serious diseases that may prevent them from entering or affecting their survival, such as cancer or AIDS;
- Any disease or condition that is not suitable for intravenous thrombolysis;
- Other diseases or conditions that the investigator believes are not suitable for the trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of Thrombolytic Therapy With Recombinant Human Tissue-type Plasminogen Activator Derivative for Acute Pulmonary Embolism
The purpose of this trial is to compare the efficacy and safety of Recombinant Human Tissue-Type Plasminogen Activator Derivative(rPA) and Recombinant Tissue-Type Plasminogen Activator(rt-PA) for the treatment of acute pulmonary embolism.
This trial includes two stages, the first stage is to study the dosage of administration of the test drug(rPA), the second is to compare the efficacy and safety of rPA and rt-PA. Both of the two stages are randomized, open and parallel controlled.
Read the detailed description
This trial is a multicenter, randomized, open and parallel controlled project designed for patients with acute pulmonary embolism requiring thrombolysis after anticoagulant therapy in high-risk and middle-high risk populations.
For the first stage: Subjects who are qualified for the screening criteria according to the inclusion and exclusion criteria will be randomly assigned to low-dose test drugs, high-dose test drugs or reference drugs for thrombolytic therapy at a ratio of 1:1:1.
For the second stage: Subjects who are qualified for the screening criteria according to the inclusion and exclusion criteria will be randomly assigned to rPA(test group)or rt-PA(control group) for thrombolytic therapy at a ratio of 1:1.
- Conditions
- Acute Pulmonary Embolism
- Being tested
- Recombinant human tissue-type plasminogen activator derivative, Recombinant human tissue-type plasminogen activator
- Keywords
- Acute Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human tissue-type plasminogen activator derivativeDrug
Also called Ruitongli
Recombinant human tissue-type plasminogen activator derivative(rPA,chemical name: Reteplase,brand name:Ruitongli) 18mg/10ml/stick, provided by AngDe Biotech Pharmaceutical Co.,LIMITED(LTD)
Recombinant human tissue-type plasminogen activatorDrug
Also called Actilyse
Recombinant human tissue-type plasminogen activator(rt-PA,chemical name:Alteplase,brand name: Actilyse)50mg/stick,provided by Boehringer Ingelheim Pharma Gesellschaft mit beschrankter Haftung(GmbH)\&Co,
| Study group | Role | What they receive |
|---|---|---|
| low dose group | Experimental | Recombinant human tissue-type plasminogen activator derivative(rPA) for injection: 18 mg, Intravenous injection for 2 minutes or more.
A separate venous access should be used for bolus injection,a common venous access shared with other drugs is not allowed for injection. And no other drugs mixed with test drug during the injection. Receives: Drug: Recombinant human tissue-type plasminogen activator derivative |
| high dose group | Experimental | Recombinant human tissue-type plasminogen activator derivative (rPA) for injection: the first injection of 18 mg rPA is pushed slowly for 2 minutes or more,the second injection of 9mg rtPA is pushed for 1 minute or more.The interval between the two injections should be controlled accurately about 30 minutes.
A separate venous access should be used for bolus injection,a common venous access shared with other drugs is not allowed for injection. And no other drugs mixed with test drug during the injection. Receives: Drug: Recombinant human tissue-type plasminogen activator derivative |
| comparative group | Active comparator | Recombinant tissue plasminogen activator for injection: continuous intravenous injection for 2 hours. Receives: Drug: Recombinant human tissue-type plasminogen activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
the opening rate of thrombus
The pulmonary artery occlusion index is calculated according to Qanadli scores. There are 10 segmental arteries in each pulmonary artery (3 in the upper lobes, 2 in the middle or lingual arteries, and 5 in the inferior lobes), 1 segment of arterial partial obstruction is 1 point, complete obstruction is 2 points, and the total score is divided by 40 (the total score of complete obstruction of bilateral pulmonary arteries) is the pulmonary artery obstruction index.
Thrombus opening rate is calculated by the Qanadli CT embolization index, the formula is as follows: improvement (%) = (significant improvement cases + mild improvement cases) / overall number of cases, significant improvement = Qanadli CT embolization index decreased from baseline ≥ 75%; mild improvement = Qanadli CT embolization index decreased by ≥25% and <75% from baseline; unchanged = Qanadli CT embolization index decreased <25% from baseline; deterioration = Qanadli CT embolization index increased from baseline.
Measured: 48 hours (Day 3)after injection
Secondary outcomes (14)
Mortality and recurrence rate
Observe the mortality and recurrence cases within in 7 days after the injection
Measured: within 7 days after injection
The incidence rates of endpoint events
endpoint events includes mortality, recurrent rate of symptomatic venous thromboembolism,hemodynamic deterioration or any other complications.
Measured: within 30 days after injection
the ratio of right ventricular end-diastolic diameter/left ventricular end-diastolic diameter
Compare the ratio of diameter before and after the thrombolytic therapy between two groups(low dose of rPA and high dose of rPA)
Measured: Day 2 (24h), Day 3 (48h), Day 7, Day 30 after injection
The ratio of N terminal pro B type natriuretic peptide/B-type natriuretic peptide
Compare the ratio of diameter before and after the thrombolytic therapy between two groups(low dose of rPA and high dose of rPA)
Measured: Day 2 (24h), Day 3 (48h), Day 7, Day 30 after injection
Thrombotic load
Compare the ratio before and after the injection
Measured: Day 3（48h）、Day 30 after injection
the opening rate of thrombus
calculated by Qanadli CT embolization index
Measured: Day 30 after injection
the occurrence rate of adverse event
Incidence of Treatment-Emergent Adverse Events
Measured: through study completion, an average of 1.5 year
blood pressure
both systolic and diastolic will be assessed
Measured: through study completion, an average of 1.5 year
life signs
body temperature
Measured: through study completion, an average of 1.5 year
pulse
the beating rate of blood through the body, which can be assessed through touching
Measured: through study completion, an average of 1.5 year
Hemoglobin
the concentration of hemoglobin will be measured and reported in the results data table
Measured: through study completion, an average of 1.5 year
red blood cell
number of red blood cells per unit will be measured and reported in the results data table
Measured: through study completion, an average of 1.5 year
white blood cell
number of white blood cells per unit will be measured and reported in the results data table
Measured: through study completion, an average of 1.5 year
platelet
number of platelet per unit will be measured and reported in the results data table
Measured: through study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study startOct 2019 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pulmonary EmbolismStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angde Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- zhenguo Zhai, Doctor, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110275
- Sponsor's protocol ID
- CRAD-RTL-203
- Acronym
- rPA
- Status last verified
- Oct 2019
- First submitted
- 24 Sep 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of Thrombolytic Therapy With Recombinant Human Tissue-type Plasminogen Activator Derivative for Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT04110275
- Acronym / sponsor ID
- rPA / CRAD-RTL-203
- Conditions
- Acute Pulmonary Embolism
- Keywords
- Acute Pulmonary Embolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Angde Biotech Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2019 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 1 Oct 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.
The purpose of this trial is to compare the efficacy and safety of Recombinant Human Tissue-Type Plasminogen Activator Derivative(rPA) and Recombinant Tissue-Type Plasminogen Activator(rt-PA) for the treatment of acute pulmonary embolism.
This trial includes two stages, the first stage is to study the dosage of administration of the test drug(rPA), the second is to compare the efficacy and safety of rPA and rt-PA. Both of the two stages are randomized, open and parallel controlled.
Detailed description
This trial is a multicenter, randomized, open and parallel controlled project designed for patients with acute pulmonary embolism requiring thrombolysis after anticoagulant therapy in high-risk and middle-high risk populations.
For the first stage: Subjects who are qualified for the screening criteria according to the inclusion and exclusion criteria will be randomly assigned to low-dose test drugs, high-dose test drugs or reference drugs for thrombolytic therapy at a ratio of 1:1:1.
For the second stage: Subjects who are qualified for the screening criteria according to the inclusion and exclusion criteria will be randomly assigned to rPA(test group)or rt-PA(control group) for thrombolytic therapy at a ratio of 1:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose group | Experimental | Drug: Recombinant human tissue-type plasminogen activator derivativeRecombinant human tissue-type plasminogen activator derivative(rPA) for injection: 18 mg, Intravenous injection for 2 minutes or more. A separate venous access should be used for bolus injection,a common venous access shared with other drugs is not allowed for injection. And no other drugs mixed with test drug during the injection. |
| high dose group | Experimental | Drug: Recombinant human tissue-type plasminogen activator derivativeRecombinant human tissue-type plasminogen activator derivative (rPA) for injection: the first injection of 18 mg rPA is pushed slowly for 2 minutes or more,the second injection of 9mg rtPA is pushed for 1 minute or more.The interval between the two injections should be controlled accurately about 30 minutes. A separate venous access should be used for bolus injection,a common venous access shared with other drugs is not allowed for injection. And no other drugs mixed with test drug during the injection. |
| comparative group | Active comparator | Drug: Recombinant human tissue-type plasminogen activatorRecombinant tissue plasminogen activator for injection: continuous intravenous injection for 2 hours. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with high-risk acute pulmonary embolism: the main manifestations are shock and hypotension.Systemic systolic blood pressure <90 millimetre of mercury (mmHg) (1mmHg=0.133kPa), or a decrease from the base value ≥40 millimetre of mercury for more than 15min.
- Patients with moderate to high-risk acute pulmonary embolism who have worsened anticoagulant therapy require thrombolytic therapy:
- (Patients with moderate to high-risk acute pulmonary embolism: Right ventricular dysfunction (RVD) and elevated cardiac biomarkers coexist.)
- RVD diagnostic criteria: imaging evidence including echocardiography or CT:1) Ultrasound examination is consistent with the following performance: 1. right ventricular dilatation (right ventricular end-diastolic diameter / left ventricular end-diastolic diameter > 1.0 or 0.9); 2. right ventricular free wall movement amplitude decreased; 3. tricuspid regurgitation speed increased; 4. tricuspid annulus systolic displacement decreased (<17mm); 2) Computed Tomographic Pulmonary Angiography examination meets the following conditions: right ventricular dilatation (right ventricular end-diastolic diameter / left ventricular end-diastolic diameter > 1.0 or 0.9) found at the four-chamber heart level;
- Cardiac biological markers including N terminal pro B type natriuretic peptide (NT-proBNP/BNP) and troponin elevation;
Key exclusion criteria (24 listed)
- a history of hemorrhagic stroke or unexplained stroke;
- Ischemic stroke or transient ischemic attack within 3 months;
- Central nervous system damage or tumor;
- Surgery and trauma of the brain or spine within 2 months;
- Active internal bleeding within 1 month (such as gastrointestinal bleeding, hemoptysis, blood in the stool, etc.);
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 human tissue-type plasminogen activator derivativeAlso: RuitongliRecombinant human tissue-type plasminogen activator derivative(rPA,chemical name: Reteplase,brand name:Ruitongli) 18mg/10ml/stick, provided by AngDe Biotech Pharmaceutical Co.,LIMITED(LTD) | Drug | high dose group, low dose group |
| Recombinant human tissue-type plasminogen activatorAlso: ActilyseRecombinant human tissue-type plasminogen activator(rt-PA,chemical name:Alteplase,brand name: Actilyse)50mg/stick,provided by Boehringer Ingelheim Pharma Gesellschaft mit beschrankter Haftung(GmbH)\&Co, | Drug | comparative group |
Primary outcome
the opening rate of thrombus
Time frame: 48 hours (Day 3)after injection
The pulmonary artery occlusion index is calculated according to Qanadli scores. There are 10 segmental arteries in each pulmonary artery (3 in the upper lobes, 2 in the middle or lingual arteries, and 5 in the inferior lobes), 1 segment of arterial partial obstruction is 1 point, complete obstruction is 2 points, and the total score is divided by 40 (the total score of complete obstruction of bilateral pulmonary arteries) is the pulmonary artery obstruction index. Thrombus opening rate is calculated by the Qanadli CT embolization index, the formula is as follows: improvement (%) = (significant improvement cases + mild improvement cases) / overall number of cases, significant improvement = Qanadli CT embolization index decreased from baseline ≥ 75%; mild improvement = Qanadli CT embolization index decreased by ≥25% and <75% from baseline; unchanged = Qanadli CT embolization index decreased <25% from baseline; deterioration = Qanadli CT embolization index increased from baseline.
14 secondary outcomes
Mortality and recurrence rate
Time frame: within 7 days after injection
The incidence rates of endpoint events
Time frame: within 30 days after injection
the ratio of right ventricular end-diastolic diameter/left ventricular end-diastolic diameter
Time frame: Day 2 (24h), Day 3 (48h), Day 7, Day 30 after injection
The ratio of N terminal pro B type natriuretic peptide/B-type natriuretic peptide
Time frame: Day 2 (24h), Day 3 (48h), Day 7, Day 30 after injection
Thrombotic load
Time frame: Day 3（48h）、Day 30 after injection
the opening rate of thrombus
Time frame: Day 30 after injection
the occurrence rate of adverse event
Time frame: through study completion, an average of 1.5 year
blood pressure
Time frame: through study completion, an average of 1.5 year
life signs
Time frame: through study completion, an average of 1.5 year
pulse
Time frame: through study completion, an average of 1.5 year
Hemoglobin
Time frame: through study completion, an average of 1.5 year
red blood cell
Time frame: through study completion, an average of 1.5 year
white blood cell
Time frame: through study completion, an average of 1.5 year
platelet
Time frame: through study completion, an average of 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Individual participant dataSharing planned: No
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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.
zhenguo Zhai, Doctor principal investigator
China-Japan Friendship Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human tissue-type plasminogen activator derivative and Recombinant human tissue-type plasminogen activator in people with Acute Pulmonary Embolism, run by Angde Biotech Pharmaceutical Co., Ltd..
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 10 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yongbiao xu, Manager (008615163577213, xuyongbiao2@crbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the opening rate of thrombus (time frame: 48 hours (Day 3)after injection). 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 11 Oct 2019.