Acute Myocardial InfarctionPhase 4NCT05466968
Intervention of Suxiao Jiuxin Pill on Instability of Vulnerable Plaque in Acute Myocardial Infarction
A Phase 4 study testing Suxiao Jiuxin Pills in people with Acute Myocardial Infarction, run by Xiaolu Li at 1 site in China.
Trial summary
The incidence of cardiovascular disease is still high in China under the condition of non-standard treatment of Western medicine. Acute coronary plaque rupture and thrombosis is an extreme manifestation of instability of "vulnerable plaque", which is the result of the joint action of multiple factors. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Suxiao Jiuxin Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-75;
- Meet the diagnosis of AMI global definition version 4，admit from emergency department;
- Prepare for emergency coronary angiography and PCI reperfusion therapy;
- Volunteer to participate in this study and have signed an informed consent form.
Who cannot join
- AMI with cardiogenic shock (Killip grade ≥ grade III) and no response to vasopressin;
- AMI complicated with severe arrhythmia (persistent ventricular tachycardia, ventricular fibrillation);
- AMI complicated with mechanical complications (ventricular septal perforation, papillary muscle rupture, intracardiac thrombus, ventricular free wall rupture);
- Severe systemic diseases (immune system diseases, sepsis and other serious infections, blood system diseases, massive hemorrhage caused by anticoagulation and antithrombotic therapy, and severe organ failure (such as ALT ≥ 3 ULN, cr> 134 μ Mol/l (2mg/dl) or egfr<45ml/min/1.73m2);
- History of cerebral hemorrhage and cerebral aneurysm within 3 months;
- Mental patients;
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- Malignant tumor or other pathophysiological condition with expected survival less than 1 year;
- Those who are allergic to the drug components of this study;
- Pregnant or lactating women;
- Patients who have participated in clinical trials of other drugs within 3 months before enrollment or took other Chinese patent medicines with similar effects within the first three months of enrollment;
- Other diseases with clinical significance that may cause serious danger to patients.
- In TCM syndrome types, Qi deficiency, Yang deficiency and other deficiency syndrome types, and cold congealing heart pulse syndrome types in positive syndrome types.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Trial of Suxiao Jiuxin Pill on the Instability of Vulnerable Plaque With Integrated Traditional Chinese Medicine and Western Medicine in Acute ST-segment Elevation Myocardial Infarction(STEMI) Patient
The incidence of cardiovascular disease is still high in China under the condition of non-standard treatment of Western medicine. Acute coronary plaque rupture and thrombosis is an extreme manifestation of instability of "vulnerable plaque", which is the result of the joint action of multiple factors. The intervention of unstable plaque reversal from multiple factors is inherently reasonable. Compared with the treatment of thrombosis and unstable plaque in western medicine, quick acting Jiuxin Pill can not only calm and relieve pain for pain and other symptoms, but also regulate immune inflammation and metabolic disorder, improve microcirculation and anti myocardial ischemia. In order to evaluate the efficacy, safety and modern scientific basis of Suxiao Jiuxin Pill in acute myocardial infarction (AMI), the investigators designed this study.
Read the detailed description
Under the condition of standardized western medicine treatment, the incidence and disability rate of cardiovascular disease in China is still high. There has been a wealth of clinical practice in the treatment of acute myocardial infarction with traditional Chinese medicine, and clinical evidence-based exploration is an inevitable trend. Suxiao Jiuxin Pill is a classic old medicine, but large-scale randomized controlled trial are still needed to consolidate the efficacy, safety and modern scientific basis in acute myocardial infarction (AMI). This pilot single center standardization research is the most basic support and exploration. This project can enhance the influence of Suxiao Jiuxin pills in the context of modern science, which will help the products to be more widely used in Chinese and western hospitals, benefit more patients, reduce the health economics cost of patients with acute ischemia of coronary heart disease at home and abroad, and reduce the social burden. From the perspective of local "vulnerable plaque" instability and "vulnerable patients" systemic inflammation outbreak driving plaque rupture, this study aims to clarify the effect of Suxiao Jiuxin Pill on thrombotic lesions, systemic and clinical short-term prognosis in patients with acute ST segment elevation myocardial infarction (STEMI) from multi-target and multi-component. This study provides evidence for the mechanism of Suxiao Jiuxin Pill in the comprehensive prevention and treatment of pathophysiological disorders in STEMI patients.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Suxiao Jiuxin Pills, The placebo of Suxiao Jiuxin Pills
- Keywords
- acute myocardial infarction, suxiao jiuxin pills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suxiao Jiuxin PillsDrug
Also called SJP group
Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).
The placebo of Suxiao Jiuxin PillsDrug
Also called Con group
The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.
| Study group | Role | What they receive |
|---|---|---|
| Suxiao Jiuxin Pills | Experimental | Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days Receives: Drug: Suxiao Jiuxin Pills |
| The placebo of Suxiao Jiuxin Pills | Placebo comparator | The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days Receives: Drug: The placebo of Suxiao Jiuxin Pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of MMP-9
MMP-9 measure by Elisa
Measured: Up to 30 minutes after administration
Secondary outcomes (11)
Changes of TIMI myocardial perfusion (TMP) of "criminal vessel".
TMP measure by CAG
Measured: Up to 30 minutes after administration
Changes in the local morphology of vulnerable plaque
Proportion of lipid / necrotic core in plaque area by IVUS
Measured: Up to 30 minutes after administration
Changes of PCSK9 in vulnerable plaque
PCSK9 measure by Elisa
Measured: Up to 30 minutes after administration
Expression changes of local SMC-FC transformation indexes in vulnerable plaque
LOX-1 measure by Elisa
Measured: Up to 30 minutes after administration
Expression changes of Local EC function index of vulnerable plaque
iNOS measure by Elisa
Measured: Up to 30 minutes after administration
Expression changes of Local angiogenic factors in vulnerable plaque
VEGF measure by Elisa
Measured: Up to 30 minutes after administration
Expression changes of indicators associated with vulnerable plaque rupture events
TNF-a measure by Elisa
Measured: Up to 30 minutes after administration
Changes in coagulation related indicators in vulnerable plaque
Coagulation factor X measure by Elisa
Measured: Up to 30 minutes after administration
The changes of inflammation related indicators
IL-6 by Omics research
Measured: 3 months after PCI
Changes of remodeling indexes
LVEF measure by UCG
Measured: 3 months after PCI
Changes in the incidence of MACE
Recurrent unstable angina pectoris, non fatal myocardial infarction, cardiogenic death, revascularization (pci+cabg), stroke, heart failure requiring hospitalization and all-cause death measure by data statistics
Measured: 3 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: Suxiao Jiuxin Pills Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days Placebo Comparator: The placebo of Suxiao Jiuxin Pills The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaolu Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaolu Li, Qianfoshan Hospital
- Investigators
- Xiaolu Li, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466968
- Sponsor's protocol ID
- YXLL-KY-2022(030)
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Suxiao Jiuxin Pill on the Instability of Vulnerable Plaque With Integrated Traditional Chinese Medicine and Western Medicine in Acute ST-segment Elevation Myocardial Infarction(STEMI) Patient
- ClinicalTrials.gov ID
- NCT05466968
- Acronym / sponsor ID
- YXLL-KY-2022(030)
- Conditions
- Acute Myocardial Infarction
- Keywords
- acute myocardial infarction, suxiao jiuxin pills
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Xiaolu LiUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 20 Jul 2022 (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 incidence of cardiovascular disease is still high in China under the condition of non-standard treatment of Western medicine. Acute coronary plaque rupture and thrombosis is an extreme manifestation of instability of "vulnerable plaque", which is the result of the joint action of multiple factors. The intervention of unstable plaque reversal from multiple factors is inherently reasonable. Compared with the treatment of thrombosis and unstable plaque in western medicine, quick acting Jiuxin Pill can not only calm and relieve pain for pain and other symptoms, but also regulate immune inflammation and metabolic disorder, improve microcirculation and anti myocardial ischemia. In order to evaluate the efficacy, safety and modern scientific basis of Suxiao Jiuxin Pill in acute myocardial infarction (AMI), the investigators designed this study.
Detailed description
Under the condition of standardized western medicine treatment, the incidence and disability rate of cardiovascular disease in China is still high. There has been a wealth of clinical practice in the treatment of acute myocardial infarction with traditional Chinese medicine, and clinical evidence-based exploration is an inevitable trend. Suxiao Jiuxin Pill is a classic old medicine, but large-scale randomized controlled trial are still needed to consolidate the efficacy, safety and modern scientific basis in acute myocardial infarction (AMI). This pilot single center standardization research is the most basic support and exploration. This project can enhance the influence of Suxiao Jiuxin pills in the context of modern science, which will help the products to be more widely used in Chinese and western hospitals, benefit more patients, reduce the health economics cost of patients with acute ischemia of coronary heart disease at home and abroad, and reduce the social burden. From the perspective of local "vulnerable plaque" instability and "vulnerable patients" systemic inflammation outbreak driving plaque rupture, this study aims to clarify the effect of Suxiao Jiuxin Pill on thrombotic lesions, systemic and clinical short-term prognosis in patients with acute ST segment elevation myocardial infarction (STEMI) from multi-target and multi-component. This study provides evidence for the mechanism of Suxiao Jiuxin Pill in the comprehensive prevention and treatment of pathophysiological disorders in STEMI patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental: Suxiao Jiuxin Pills Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days Placebo Comparator: The placebo of Suxiao Jiuxin Pills The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days
| Arm | Type | Receives |
|---|---|---|
| Suxiao Jiuxin Pills | Experimental | Drug: Suxiao Jiuxin PillsSuxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days |
| The placebo of Suxiao Jiuxin Pills | Placebo comparator | Drug: The placebo of Suxiao Jiuxin PillsThe placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 18-75;
- Meet the diagnosis of AMI global definition version 4，admit from emergency department;
- Prepare for emergency coronary angiography and PCI reperfusion therapy;
- Volunteer to participate in this study and have signed an informed consent form.
Key exclusion criteria (12 listed)
- AMI with cardiogenic shock (Killip grade ≥ grade III) and no response to vasopressin;
- AMI complicated with severe arrhythmia (persistent ventricular tachycardia, ventricular fibrillation);
- AMI complicated with mechanical complications (ventricular septal perforation, papillary muscle rupture, intracardiac thrombus, ventricular free wall rupture);
- Severe systemic diseases (immune system diseases, sepsis and other serious infections, blood system diseases, massive hemorrhage caused by anticoagulation and antithrombotic therapy, and severe organ failure (such as ALT ≥ 3 ULN, cr> 134 μ Mol/l (2mg/dl) or egfr<45ml/min/1.73m2);
- History of cerebral hemorrhage and cerebral aneurysm within 3 months;
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 |
|---|---|---|
| Suxiao Jiuxin PillsAlso: SJP groupSuxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian). | Drug | Suxiao Jiuxin Pills |
| The placebo of Suxiao Jiuxin PillsAlso: Con groupThe placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste. | Drug | The placebo of Suxiao Jiuxin Pills |
Primary outcome
Changes of MMP-9
Time frame: Up to 30 minutes after administration
MMP-9 measure by Elisa
11 secondary outcomes
Changes of TIMI myocardial perfusion (TMP) of "criminal vessel".
Time frame: Up to 30 minutes after administration
Changes in the local morphology of vulnerable plaque
Time frame: Up to 30 minutes after administration
Changes of PCSK9 in vulnerable plaque
Time frame: Up to 30 minutes after administration
Expression changes of local SMC-FC transformation indexes in vulnerable plaque
Time frame: Up to 30 minutes after administration
Expression changes of Local EC function index of vulnerable plaque
Time frame: Up to 30 minutes after administration
Expression changes of Local angiogenic factors in vulnerable plaque
Time frame: Up to 30 minutes after administration
Expression changes of indicators associated with vulnerable plaque rupture events
Time frame: Up to 30 minutes after administration
Changes in coagulation related indicators in vulnerable plaque
Time frame: Up to 30 minutes after administration
The changes of inflammation related indicators
Time frame: 3 months after PCI
Changes of remodeling indexes
Time frame: 3 months after PCI
Changes in the incidence of MACE
Time frame: 3 months after PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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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.
Xiaolu Li principal investigator
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suxiao Jiuxin Pills in people with Acute Myocardial Infarction, run by Xiaolu Li at 1 site 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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nannan Li (15865266456, 1003023531@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of MMP-9 (time frame: Up to 30 minutes after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2022.