Actively Recruiting
Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism
Led by Supergene, LLC · Updated on 2025-12-05
486
Participants Needed
24
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE)
CONDITIONS
Official Title
Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 and over
- Verified diagnosis of intermediate high-risk PE by CTPA within 2 weeks of symptom onset
- Right ventricular dysfunction with RV/LV end-diastolic diameter ratio over 1.0 by CTPA
- Increased risk of early death or hemodynamic collapse defined by:
- Systolic blood pressure between 90 and 110 mm Hg for more than 15 minutes
- Respiratory rate over 20 per minute or oxygen saturation under 90% without oxygen support
- Chronic heart failure with left ventricular ejection fraction under 40%
- Serum troponin I levels over 14 pg/mL if under 75 years, or over 45 pg/mL if 75 years or older
- Use of reliable contraception throughout the study and for 3 weeks after, including documented infertility or menopause for women, and use of barrier contraception or documented infertility for men
- Signed and dated informed consent to participate
You will not qualify if you...
- High-risk PE with hemodynamic instability
- Current or recent (within 6 months) extensive bleeding or intracranial hemorrhage
- Hemorrhagic stroke within the last 6 months
- History of central nervous system diseases including tumors or aneurysms
- Intracranial or spinal surgery within the last 2 months
- Major surgery or trauma within the last 4 weeks
- Recent puncture of an incompressible blood vessel
- Severe liver disease or active hepatitis
- Confirmed gastric or duodenal ulcer within the last 3 months
- Neoplasm with increased bleeding risk
- Use of Dabigatran without prior idarucizumab administration
- Arterial aneurysms or vascular developmental defects
- Acute pancreatitis
- Bacterial endocarditis or pericarditis
- Suspected aortic dissecting aneurysm
- Any other condition deemed by the investigator to pose high bleeding risk
- Pregnancy or lactation
- Known allergy to non-immunogenic recombinant staphylokinase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
RZD Medicine hospital
Barnaul, Altayskiy Kray, Russia, 656038
Actively Recruiting
2
V.F. Dolgopolov Vyselki Central District Hospital
Vyselki, Krasnodarskiy Kray, Russia, 353100
Actively Recruiting
3
Asinovskaya District Hospital
Asino, Tomsk Oblast, Russia, 636840
Completed
4
Belgorod Regional Clinical Hospital of St. Joseph
Belgorod, Russia, 308007
Actively Recruiting
5
Kuzbass Cardiology center
Kemerovo, Russia, 650002
Actively Recruiting
6
Center of Neurology and Cardiology
Kirov, Russia, 610035
Actively Recruiting
7
Regional Clinical Hospital №2
Krasnodar, Russia, 350012
Actively Recruiting
8
Lipetsk City Hospital No. 4 "Lipetsk-Med"
Lipetsk, Russia, 398006
Actively Recruiting
9
F.I. Inozemtsev City Clinical Hospital
Moscow, Russia, 105187
Actively Recruiting
10
Moscow Multidisciplinary Clinical Center "Kommunarka"
Moscow, Russia, 108814
Actively Recruiting
11
S.S. Yudin City Clinical Hospital
Moscow, Russia, 115446
Actively Recruiting
12
V.M. Buyanov City Clinical Hospital
Moscow, Russia, 115516
Actively Recruiting
13
S.P. Botkin City Clinical Hospital
Moscow, Russia
Actively Recruiting
14
N.A. Semashko Nizhny Novgorod Regional Clinical Hospital
Nizhny Novgorod, Russia, 603093
Actively Recruiting
15
N.N. Burdenko Penza Regional Clinical hospital
Penza, Russia, 440026
Withdrawn
16
G.A. Zakharyin Clinical hospital №6
Penza, Russia, 440071
Actively Recruiting
17
City Clinical Hospital №4
Perm, Russia, 614107
Withdrawn
18
City Hospital No. 26
Saint Petersburg, Russia, 196247
Actively Recruiting
19
City Hospital No. 15
Saint Petersburg, Russia, 198205
Actively Recruiting
20
V.P. Polyakov Samara Regional Clinical Cardiology Dispensary
Samara, Russia, 443070
Actively Recruiting
21
Tomsk regional cilinical hospital
Tomsk, Russia, 634063
Actively Recruiting
22
Tver Regional Clinical Hospital
Tver', Russia, 170036
Actively Recruiting
23
Ufa Emergency City Hospital
Ufa, Russia, 450092
Actively Recruiting
24
City Clinical Hospital of Emergency medicine №25
Volgograd, Russia, 400138
Actively Recruiting
Research Team
S
Sergey S. Markin, MD, PhD
CONTACT
S
Sergey N. Tereschenko, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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