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Safety, tolerability, pharmacokinetics, and pharmacodynamics of recombinant neorudin (yeast) for injection in the treatment of non-ST-segment elevation acute coronary syndrome (NSTE-ACS)

Clinical study of recombinant neorudin (yeast) for injection

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050044
Enrollment
Unknown
Registered
2021-08-16
Start date
2021-08-16
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-ST-segment elevation acute coronary syndrome (NSTE-ACS)

Interventions

test group:No

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. There is no gender limit, and the age is between 18 and 75 years old (including the threshold); 2. Patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) with relatively stable disease and no indication for emergency interventional therapy, with a GRACE score of 140 but the patient clearly refuses to undergo interventional therapy (medical records). The written word in Chinese shall indicate "rejection of interventional treatment" and sign); 3. Ischemic pain lasting more than 10 minutes within 24 hours before admission, or clinical symptoms equivalent to it, such as chest tightness, suffocation, pressure, etc.; 4. Symptom-related ECG changes: new or possibly new ST-segment depression greater than or equal to 0.1 mV (greater than or equal to 1 mm) or short-term ST-segment elevation greater than or equal to 0.1 mV (at least 2 consecutive leads) ; 5. Subjects with BMI <35kg/m2; voluntarily participate in the test and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Hypertension that cannot be controlled with medication (systolic > 180mmHg, or diastolic > 110mmHg); 2. Increased risk of bleeding; previous hemorrhagic stroke; intracranial aneurysm; Trauma or major surgery (including bypass surgery) within 1 month; currently suffering from active bleeding diseases; 3. Patients with gastrointestinal ulcer, gastrointestinal hemorrhage history or current positive fecal occult blood; 4. Have clear anticoagulant indications other than ACS, are using anticoagulants or have a large number of antiplatelet drugs within 24 hours (e.g., clopidogrel sulfate load >=300mg/ day, ticagrelor tablet load 180mg/day; Aspirin 300mg/ day); 5. Patients receiving heparin/LMWH within 12h; 6. Activated partial thrombin time (APTT) was greater than the upper limit of normal; 7. The time of cardio-pulmonary resuscitation was more than 10 minutes in the past 4 weeks; 8. Serious organic heart disease: LVEF=3xULN or total bilirubin (TBIL) >=2xULN; or creatinine clearance rate (Ccr) =400ml) within the last 3 months; 16. A previous history of alcohol abuse (i.e., 28 or more units per week for men and 21 or more units per week for women (1 unit contains 14g of alcohol, such as 360mL beer or 25mL 40% alcohol or 150mL wine); or drinking regularly (i.e., more than 14 standard units per week) in the 6 months prior to screening; or unable to abstain from alcohol during the experiment; 17. A history of drug abuse or drug dependence within 1 year before screening; 18. Participation in other clinical trials and taken experimental drugs in recent 3 months; 19. Other conditions that the investigator considers inappropriate for this study.

Design outcomes

Primary

MeasureTime frame
APTT, TT;

Secondary

MeasureTime frame
D-dimer and fibrinogen degradation products;

Countries

China

Contacts

Public ContactLiang Yan, Liu Huichen

Fuwai Hospital, Chinese Academy of Medical Sciences

fwliangyan2016@163.com+86 15699870217

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026