Myocardial Reperfusion InjuryPhase 2NCT03995732
Efficacy and Safety Evaluation of PC-SOD for Injection in Reducing Myocardial Reperfusion Injury
A Phase 2 study testing PC-SOD in people with Myocardial Reperfusion Injury, run by Beijing Tide Pharmaceutical Co., Ltd at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Reperfusion Injury
- What is being tested?
- PC-SOD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 18 Jun 2019to 30 Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 75 years, male or female;
- 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 );
- Killip classes I or II;
- Coronary angiography possible within 6 hours of onset;
- 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);
- Willingness to participate in the trial with ethical approval and informed consent provision.
Who cannot join
- General exclusion criteria
- Previous history of myocardial infarction;
- History of myocardial revascularization before screening;
- Thrombolytic treatment after onset;
- Cardiogenic shock;
- Cardiopulmonary resuscitation between onset and screening;
Show all 20Show fewer
- Atrial fibrillation, atrioventricular block (degree I, II or III), and other severe arrhythmias that cannot be corrected and affect hemodynamics;
- Suspected of aortic dissection;
- Diabetes with long-term insulin use, or definite macrovascular or small vascular lesions (stroke, diabetic nephropathy, retinopathy, diabetic foot, and etc.);
- History of major surgeries within 6 months;
- History of stroke within 6 months;
- 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;
- 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;
- Allergy to two or more drugs and/or foods, or known allergy to sucrose;
- 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);
- Pregnancy or lactation in women;
- Participation in other clinical trials within 3 months;
- Situations considered unsuitable for enrollment (such as disease condition or patient compliance).
- Occlusion of left main artery;
- Apart from the left anterior descending branch, other blood vessels requiring revascularization in the same period or within a month.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Ge Junbo, MD, ge.junbo@zs-hospital.sh.cn
- Not yet recruiting
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
Su Xi, MD
About this study
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
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.
Read the 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.
- Conditions
- Myocardial Reperfusion Injury
- Being tested
- PC-SOD, placebo
- Medical subject headings
- Myocardial Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC-SODDrug
PC-SOD will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
placeboDrug
Placebo will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
| Study group | Role | What they receive |
|---|---|---|
| 40 mg treatment group | Experimental | PC-SOD 40 mg dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization. Receives: Drug: PC-SOD |
| 80 mg treatment group | Experimental | PC-SOD 80 mg dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization. Receives: Drug: PC-SOD |
| 160 mg treatment group | Experimental | PC-SOD 160 mg dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization. Receives: Drug: PC-SOD |
| placebo control group | Placebo comparator | placebo dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The myocardial salvage index at 7 d after PCI
The myocardial salvage index is defined as (area of myocardial edema - area of myocardial infarction)/area of myocardial edema.
Measured: 7 days
The area of myocardial infarction at 7 d after PCI (detected by delayed-enhanced MRI [Magnetic Resonance Imaging] )
The area of myocardial infarction is defined as the percentage of left ventricular myocardium occupied by delayed enhancement.
Measured: 7 days
Area of microvascular occlusion at 7 d after PCI
Microvascular occlusion is defined as the area with no enhancement in the infarcted regions where delayed enhancement can be observed on MRI scans.
Measured: 7 days
The area of infarction determined by the AUC (area under curve) for CK-MB (creatine kinase-muscle/brain) at 72h after PCI.
The area of infarction at 72h after surgery will be roughly estimated by calculating the AUC for CK-MB (before operation, and at 6, 12, 24, 48 and 72h after operation, respectively).
Measured: 72 hours
Cardiac function at 7 d after PCI
Cardiac function is assessed by assessing the left ventricular ejection fraction (percentage of stroke output to end-diastolic volume).
Measured: 7 days
The TIMI (thrombolysis in myocardial infarction) grade of coronary blood flow after PCI.
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.
Measured: within 24 hours
The corrected TIMI frame count (cTFC) after PCI.
The left anterior descending (LAD) artery will be analyzed in a 30º right anterior oblique view with 30º cranial angulation. The left circumflex (LCX) will be analyzed in a 30º right anterior oblique view with 30º caudal angulation. The right coronary artery (RCA) will be analyzed in a 45º left anterior oblique view.
Measured: within 24 hours
TIMI myocardial perfusion grade (TMPG) after PCI
Grade 0: no contrast entering the myocardium; Grade 1: the contrast enters myocardium slowly, with myocardial staining not disappearing or lasting for more than 30 s in the targeted vessels; Grade 2: delayed entering and disappearing of contrast in the myocardium, exceeding 3 cardiac cycles; Grade 3: normal entering and disappearing of contrast in the myocardium, occurring within 3 cardiac cycles.
Measured: within 24 hours
Percentage of ST-segment resolution on ECG (electrocardiogram) at 90 min after PCI
ST-resolution is defined as more than 50% of resolution.
Measured: 90 minutes
Number of cardiovascular events within 30 d after PCI
Cardiovascular events included all-cause death, cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization due to heart failure.
Measured: 30 days
SOD (Superoxide Dismutase) activity
Change from Baseline SOD activity at 6h, 12h, 24h, 48h, 72h and 7 d after surgery.
Measured: 0 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
Occurence of adverse events
Occurence of adverse events
Measured: During patient hospitalization, up to 30 days
Cardiac function at 30 d after PCI
Cardiac function is assessed by assessing the left ventricular ejection fraction (percentage of stroke output to end-diastolic volume).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start18 Jun 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Myocardial Reperfusion InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tide Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995732
- Sponsor's protocol ID
- CY-RD101-2
- Other IDs
- GUSU18003
- Status last verified
- Sep 2019
- First submitted
- 5 Jun 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17855673Zweier 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.
PubMed 2826476Werns 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.
PubMed 2185587Kloner 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.
PubMed 2553296Przyklenk 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.
PubMed 3943152Engler 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.
PubMed 2653661Igarashi 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.
PubMed 7996483Wu 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.
PubMed 18070953
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03995732
- Acronym / sponsor ID
- CY-RD101-2
- Conditions
- Myocardial Reperfusion Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tide Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 40 mg treatment group | Experimental | Drug: PC-SODPC-SOD 40 mg dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization. |
| 80 mg treatment group | Experimental | Drug: PC-SODPC-SOD 80 mg dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization. |
| 160 mg treatment group | Experimental | Drug: PC-SODPC-SOD 160 mg dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization. |
| placebo control group | Placebo comparator | Drug: placeboplacebo dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 - 75 years, male or female;
- 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 );
- Killip classes I or II;
- Coronary angiography possible within 6 hours of onset;
- 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);
Key exclusion criteria (20 listed)
- General exclusion criteria
- Previous history of myocardial infarction;
- History of myocardial revascularization before screening;
- Thrombolytic treatment after onset;
- Cardiogenic shock;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC-SODPC-SOD will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization. | Drug | 160 mg treatment group, 40 mg treatment group, 80 mg treatment group |
| placeboPlacebo will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization. | Drug | placebo control group |
Primary outcome
The myocardial salvage index at 7 d after PCI
Time frame: 7 days
The myocardial salvage index is defined as (area of myocardial edema - area of myocardial infarction)/area of myocardial edema.
The area of myocardial infarction at 7 d after PCI (detected by delayed-enhanced MRI [Magnetic Resonance Imaging] )
Time frame: 7 days
The area of myocardial infarction is defined as the percentage of left ventricular myocardium occupied by delayed enhancement.
Area of microvascular occlusion at 7 d after PCI
Time frame: 7 days
Microvascular occlusion is defined as the area with no enhancement in the infarcted regions where delayed enhancement can be observed on MRI scans.
The area of infarction determined by the AUC (area under curve) for CK-MB (creatine kinase-muscle/brain) at 72h after PCI.
Time frame: 72 hours
The area of infarction at 72h after surgery will be roughly estimated by calculating the AUC for CK-MB (before operation, and at 6, 12, 24, 48 and 72h after operation, respectively).
Cardiac function at 7 d after PCI
Time frame: 7 days
Cardiac function is assessed by assessing the left ventricular ejection fraction (percentage of stroke output to end-diastolic volume).
The TIMI (thrombolysis in myocardial infarction) grade of coronary blood flow after PCI.
Time frame: within 24 hours
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.
The corrected TIMI frame count (cTFC) after PCI.
Time frame: within 24 hours
The left anterior descending (LAD) artery will be analyzed in a 30º right anterior oblique view with 30º cranial angulation. The left circumflex (LCX) will be analyzed in a 30º right anterior oblique view with 30º caudal angulation. The right coronary artery (RCA) will be analyzed in a 45º left anterior oblique view.
TIMI myocardial perfusion grade (TMPG) after PCI
Time frame: within 24 hours
Grade 0: no contrast entering the myocardium; Grade 1: the contrast enters myocardium slowly, with myocardial staining not disappearing or lasting for more than 30 s in the targeted vessels; Grade 2: delayed entering and disappearing of contrast in the myocardium, exceeding 3 cardiac cycles; Grade 3: normal entering and disappearing of contrast in the myocardium, occurring within 3 cardiac cycles.
Percentage of ST-segment resolution on ECG (electrocardiogram) at 90 min after PCI
Time frame: 90 minutes
ST-resolution is defined as more than 50% of resolution.
Number of cardiovascular events within 30 d after PCI
Time frame: 30 days
Cardiovascular events included all-cause death, cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization due to heart failure.
SOD (Superoxide Dismutase) activity
Time frame: 0 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
Change from Baseline SOD activity at 6h, 12h, 24h, 48h, 72h and 7 d after surgery.
Occurence of adverse events
Time frame: During patient hospitalization, up to 30 days
Occurence of adverse events
Cardiac function at 30 d after PCI
Time frame: 30 days
Cardiac function is assessed by assessing the left ventricular ejection fraction (percentage of stroke output to end-diastolic volume).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 17855673Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. doi: 10.1056/NEJMra071667. No abstract available.
- Background: PubMed 2826476Zweier 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.
- Background: PubMed 2185587Werns 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.
- Background: PubMed 2553296Kloner 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.
- Background: PubMed 3943152Przyklenk 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.
- Background: PubMed 2653661Engler 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.
- Background: PubMed 7996483Igarashi 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.
- Background: PubMed 18070953Wu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PC-SOD in people with Myocardial Reperfusion Injury, run by Beijing Tide Pharmaceutical Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huo Yong, master (13901333060, drhuoyong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The myocardial salvage index at 7 d after PCI (time frame: 7 days). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03995732, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.