Condition or disease | Intervention/treatment | Phase |
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Myocardial Reperfusion Injury | Drug: PC-SOD Drug: placebo | Phase 2 |
The study is a randomized, single-blind, multi-center, placebo-controlled trial to preliminarily evaluate the efficacy and safety of PC-SOD, and to provide a basis for dose selection in the next stage of study.
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Masking Description: | Since the appearance of PC-SOD preparations cannot be identical to that of placebo, and treatment groups have different administration doses, the study will be conducted in a single-blind manner, where only subjects (and families) are blinded and do not know whether they are treated by PC-SOD or placebo before unblinding. 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. |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety Evaluation of Phosphatidyl Choline Cu/Zn Superoxide Dismutase (PC-SOD) for Injection in Reducing Myocardial Reperfusion Injury: a Multicenter, Randomized, Single-blind, Placebo-controlled Dose-finding Study |
Actual Study Start Date : | June 18, 2019 |
Estimated Primary Completion Date : | October 31, 2020 |
Estimated Study Completion Date : | March 30, 2021 |
Arm | Intervention/treatment |
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Experimental: 40 mg treatment group
PC-SOD 40 mg dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
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Drug: PC-SOD
PC-SOD will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
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Experimental: 80 mg treatment group
PC-SOD 80 mg dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
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Drug: PC-SOD
PC-SOD will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
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Experimental: 160 mg treatment group
PC-SOD 160 mg dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
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Drug: PC-SOD
PC-SOD will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
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Placebo Comparator: placebo control group
placebo dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
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Drug: placebo
Placebo will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
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Coronary artery reperfusion will be assessed by the TIMI grading system, whose grades include:
Grade 0: no contrast filling at the occlusion site and distal end; Grade 1: the contrast passes some of the occluded sites, but cannot fill the distal vessels; Grade 2: the contrast can fill the distal end of coronary artery completely, but the filling and clearing of contrast is slower than that of normal coronary artery; Grade 3: the contrast can fill the distal end rapidly and completely, and can be removed quickly.
The TIMI flow grades will be determined by two physicians separately. In case of disagreement, a lead physician will help make the final call.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
General exclusion criteria
Exclusion criteria for angiography
Contact: Huo Yong, master | 13901333060 | drhuoyong@163.com |
China, Hubei | |
Wuhan Asia Heart Hospital | Not yet recruiting |
Wuhan, Hubei, China, 430022 | |
Contact: Su Xi, MD | |
China, Shanghai | |
Zhongshan Hospital | Recruiting |
Shanghai, Shanghai, China, 200032 | |
Contact: Ge Junbo, MD ge.junbo@zs-hospital.sh.cn |
Tracking Information | |||||
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First Submitted Date ICMJE | June 5, 2019 | ||||
First Posted Date ICMJE | June 24, 2019 | ||||
Last Update Posted Date | September 26, 2019 | ||||
Actual Study Start Date ICMJE | June 18, 2019 | ||||
Estimated Primary Completion Date | October 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy and Safety Evaluation of PC-SOD for Injection in Reducing Myocardial Reperfusion Injury | ||||
Official Title ICMJE | Efficacy and Safety Evaluation of Phosphatidyl Choline Cu/Zn Superoxide Dismutase (PC-SOD) for Injection in Reducing Myocardial Reperfusion Injury: a Multicenter, Randomized, Single-blind, Placebo-controlled Dose-finding Study | ||||
Brief Summary | The current study aims to evaluate different doses of PC-SOD injections for efficacy and safety in comparison to placebo, in order to provide a basis for future clinical trials in terms of experimental design and dose selection. | ||||
Detailed Description |
The study is a randomized, single-blind, multi-center, placebo-controlled trial to preliminarily evaluate the efficacy and safety of PC-SOD, and to provide a basis for dose selection in the next stage of study. 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Masking Description: Since the appearance of PC-SOD preparations cannot be identical to that of placebo, and treatment groups have different administration doses, the study will be conducted in a single-blind manner, where only subjects (and families) are blinded and do not know whether they are treated by PC-SOD or placebo before unblinding. 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. |
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Condition ICMJE | Myocardial Reperfusion Injury | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
120 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 30, 2021 | ||||
Estimated Primary Completion Date | October 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: General exclusion criteria
Exclusion criteria for angiography
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03995732 | ||||
Other Study ID Numbers ICMJE | CY-RD101-2 GUSU18003 ( Other Identifier: GUSU Group ) |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Beijing Tide Pharmaceutical Co., Ltd | ||||
Study Sponsor ICMJE | Beijing Tide Pharmaceutical Co., Ltd | ||||
Collaborators ICMJE | Peking University First Hospital | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Beijing Tide Pharmaceutical Co., Ltd | ||||
Verification Date | September 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |