Efficacy and Safety Evaluation of PC-SOD for Injection in Reducing Myocardial Reperfusion Injury
NCT ID: NCT03995732
Last Updated: 2019-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2019-06-18
2021-03-30
Brief Summary
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Detailed Description
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For each participant, the trial will be divided into the screening/treatment (screening and treatment conducted during the first visit, 0 d) and safety follow-up (1 - 30 d) stages.
The study will screen 120 eligible subjects. After successful screening, the subjects will be randomly assigned into four groups of equal size, including the 40 mg PC-SOD, 80 mg PC-SOD, 160 mg PC-SOD and placebo control groups. Subjects in each group will be administered the corresponding intervention, followed by PCI treatment. During the safety follow-up stage, the subjects will receive basic treatment based on Guidelines for Management of Patients with ST-segment elevation myocardial infarction. Treatments will include dual anti-platelet therapy, beta-blockers, ACEI/ARB (angiotensin-converting enzyme inhibitor/ angiotensin receptor blocker), statins, anticoagulants, and so on.
By comparing the efficacy and safety endpoints of patients in the experimental and placebo control groups, the study aims to preliminarily evaluate the efficacy and safety of different doses of PC-SOD in reducing myocardial reperfusion injury.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interpretation of cardiac MRI and ECG will also be conducted in a blinding manner. Images of all subjects will be evaluated blindly by researchers not directly involved in the study.
Study Groups
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40 mg treatment group
PC-SOD 40 mg dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
PC-SOD
PC-SOD will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
80 mg treatment group
PC-SOD 80 mg dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
PC-SOD
PC-SOD will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
160 mg treatment group
PC-SOD 160 mg dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
PC-SOD
PC-SOD will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
placebo control group
placebo dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
placebo
Placebo will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
Interventions
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PC-SOD
PC-SOD will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
placebo
Placebo will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
Eligibility Criteria
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Inclusion Criteria
2. Meeting the diagnostic criteria of AMI (chest pain for over 10 - 20 min, which could not be relieved completely by oral nitroglycerin; ST elevation ≥ 2 mm in two or more adjacent leads in leads V1-V5 );
3. Killip classes I or II;
4. Coronary angiography possible within 6 hours of onset;
5. Emergent coronary angiography showing occlusion in left anterior descending artery (TIMI grade 0 - 1); patients with this symptom could also be included despite inconformity to criterion 2);
6. Willingness to participate in the trial with ethical approval and informed consent provision.
Exclusion Criteria
2. History of myocardial revascularization before screening;
3. Thrombolytic treatment after onset;
4. Cardiogenic shock;
5. Cardiopulmonary resuscitation between onset and screening;
6. Atrial fibrillation, atrioventricular block (degree I, II or III), and other severe arrhythmias that cannot be corrected and affect hemodynamics;
7. Suspected of aortic dissection;
8. Diabetes with long-term insulin use, or definite macrovascular or small vascular lesions (stroke, diabetic nephropathy, retinopathy, diabetic foot, and etc.);
9. History of major surgeries within 6 months;
10. History of stroke within 6 months;
11. History of immune disorders within 6 months (such as cancer, lymphoma, HIV or hepatitis), or use of immunosuppressive agents at doses that can cause immunosuppression within 10 days;
12. Clinically significant diseases of the respiratory, digestive, blood, immune, endocrine, nervous or urinary systems (renal insufficiency in particular), and diseases that might cause serious risk to patients based on the judgement of researchers;
13. Allergy to two or more drugs and/or foods, or known allergy to sucrose;
14. Any contraindications for cardiac MRI, such as implantation of metal objects (pacemakers and/or implantable defibrillators; insulin pumps, or any other electronic devices; cerebral clips, aneurysm clips, and etc.), and other contraindications (such as claustrophobia);
15. Pregnancy or lactation in women;
16. Participation in other clinical trials within 3 months;
17. Situations considered unsuitable for enrollment (such as disease condition or patient compliance).
1. Occlusion of left main artery;
2. Apart from the left anterior descending branch, other blood vessels requiring revascularization in the same period or within a month.
18 Years
75 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Beijing Tide Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Su Xi, MD
Role: primary
References
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Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. doi: 10.1056/NEJMra071667. No abstract available.
Zweier JL. Measurement of superoxide-derived free radicals in the reperfused heart. Evidence for a free radical mechanism of reperfusion injury. J Biol Chem. 1988 Jan 25;263(3):1353-7.
Werns SW, Lucchesi BR. Free radicals and ischemic tissue injury. Trends Pharmacol Sci. 1990 Apr;11(4):161-6. doi: 10.1016/0165-6147(90)90068-J.
Kloner RA, Przyklenk K, Whittaker P. Deleterious effects of oxygen radicals in ischemia/reperfusion. Resolved and unresolved issues. Circulation. 1989 Nov;80(5):1115-27. doi: 10.1161/01.cir.80.5.1115.
Przyklenk K, Kloner RA. Superoxide dismutase plus catalase improve contractile function in the canine model of the "stunned myocardium". Circ Res. 1986 Jan;58(1):148-56. doi: 10.1161/01.res.58.1.148.
Engler R, Gilpin E. Can superoxide dismutase alter myocardial infarct size? Circulation. 1989 May;79(5):1137-42. doi: 10.1161/01.cir.79.5.1137. No abstract available.
Igarashi R, Hoshino J, Ochiai A, Morizawa Y, Mizushima Y. Lecithinized superoxide dismutase enhances its pharmacologic potency by increasing its cell membrane affinity. J Pharmacol Exp Ther. 1994 Dec;271(3):1672-7.
Wu E, Ortiz JT, Tejedor P, Lee DC, Bucciarelli-Ducci C, Kansal P, Carr JC, Holly TA, Lloyd-Jones D, Klocke FJ, Bonow RO. Infarct size by contrast enhanced cardiac magnetic resonance is a stronger predictor of outcomes than left ventricular ejection fraction or end-systolic volume index: prospective cohort study. Heart. 2008 Jun;94(6):730-6. doi: 10.1136/hrt.2007.122622. Epub 2007 Dec 10.
Other Identifiers
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GUSU18003
Identifier Type: OTHER
Identifier Source: secondary_id
CY-RD101-2
Identifier Type: -
Identifier Source: org_study_id
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