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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
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 activator(rt-PA,chemical name:Alteplase,brand name: Actilyse)50mg/stick,provided by Boehringer Ingelheim Pharma Gesellschaft mit beschrankter Haftung(GmbH)\&Co,
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.
Time frame: 48 hours (Day 3)after injection
Mortality and recurrence rate
Observe the mortality and recurrence cases within in 7 days after the injection
Time frame: 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.
Time frame: 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)
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
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Compare the ratio of diameter before and after the thrombolytic therapy between two groups(low dose of rPA and high dose of rPA)
Time frame: Day 2 (24h), Day 3 (48h), Day 7, Day 30 after injection
Thrombotic load
Compare the ratio before and after the injection
Time frame: Day 3(48h)、Day 30 after injection
the opening rate of thrombus
calculated by Qanadli CT embolization index
Time frame: Day 30 after injection
the occurrence rate of adverse event
Incidence of Treatment-Emergent Adverse Events
Time frame: through study completion, an average of 1.5 year
blood pressure
both systolic and diastolic will be assessed
Time frame: through study completion, an average of 1.5 year
life signs
body temperature
Time frame: through study completion, an average of 1.5 year
pulse
the beating rate of blood through the body, which can be assessed through touching
Time frame: through study completion, an average of 1.5 year
Hemoglobin
the concentration of hemoglobin will be measured and reported in the results data table
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1.5 year