Last updated: August 1, 2022
Sponsor: Beijing Northland Biotech. Co., Ltd.
Overall Status: Completed
Phase
2
Condition
Heart Disease
Cardiovascular Disease
Hypercholesterolemia
Treatment
N/AClinical Study ID
NCT05485818
NL005-AMI-IIa
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The subject or its legal representative will voluntarily participate in the study andsign the informed consent;
- Age 18 and 75, regardless of gender;
- STEMI patients with left anterior descending branch single-artery middle occlusion (TIMI grading 0~1, see Appendix 1 for TIMI grading) and receiving PCI;
- No obvious collateral of coronary artery (Rentrop grade 0~1,Rentrop grade see Appendix 2);
- Chest pain occurred for 6 hours and 12 hours before PCI;
- TIMI grade 3 after PCI;
- All subjects (male and female) must agree to use appropriate contraceptive methods (hormonal or barrier contraceptive methods, abstinence) during the study period and upto 6 months after the last administration, and women of childbearing age must testnegative for pregnancy before administration.
Exclusion
Exclusion Criteria:
- Patients who have a history of myocardial infarction or have received coronary arteryacute thrombolytic interventional therapy with bypass surgery;
- patients who received thrombolytic therapy after onset;
- patients who were clearly diagnosed as acute heart failure (Killip grade II,Killipclassification in annex 3);
- Severe arrhythmia that cannot be corrected;
- Aortic dissection or suspected presence;
- Severe liver and kidney dysfunction or severe depletion, etc;
- major surgical history or hemorrhagic stroke in half a year;
- Has or has a history of malignancy;
- Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg inpatients with hypertension after active antihypertensive treatment;
- Clinically, he had a significant history of allergy, especially to mannitol, drugs,protein preparations and biological products;
- Screening of patients who participated in other clinical studies within the first 3months;
- Failure to perform CMR test: such as claustrophobia, renal failure (eGFR < 30ml/min);
- Other conditions not considered suitable for inclusion by the researcher.
Study Design
Total Participants: 62
Study Start date:
November 23, 2020
Estimated Completion Date:
November 18, 2021
Study Description
Connect with a study center
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing,
ChinaSite Not Available

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