Acute Coronary SyndromePhase 4NCT04814121
Suxiao Jiuxin Pills in Microvascular Obstruction in Patients With Acute Coronary Syndrome
A Phase 4 study testing Suxiao Jiuxin Pills in people with Acute Coronary Syndrome, run by Guangzhou University of Traditional Chinese Medicine.
Trial summary
Microvascular obstruction is the severe complication of percutaneous coronary intervention (PCI) in patients with acute coronary syndrome. Microvascular obstruction after PCI is often association with poor prognosis. Current treatments do not show improvement in prognosis of microvascular obstruction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome
- 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
- 198 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 30 Sep 2023
- Phase
- Phase 4
- 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
- Meet the diagnosis of AMI, prepare for PCI reperfusion therapy;
- Between the ages of 18-75;
- Volunteer to participate in this study and have signed an informed consent form;
- Have a correct understanding of the significance of drug research, and have a good compliance with the observation and evaluation.
Who cannot join
- Not suitable for coronary intervention;
- With unstable hemodynamics;
- Platelet count<100×109;
- Suspected aortic dissection or acute pulmonary embolism;
- With mechanical complications;
- With uncontrolled acute left heart failure and pulmonary edema;
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- With known bleeding history, active bleeding, bleeding constitution, or severe hemostatic and coagulation dysfunction;
- Meantain anticoagulants (such as warfarin or new anticoagulants);
- Severe liver and kidney insufficiency (Child-Pugh B and above, Cr>177μmol/L (2mg/dl) or eGFR<45ml/min/1.73m2);
- CTO, stent stenosis, or severe left main disease;
- History of coronary artery bypass graft surgery;
- Other pathophysiological conditions whose expected survival period is less than 1 year;
- Allergic history to Suxiao Jiuxin Pills;
- Pregnant or lactating women;
- Participating in other clinical studies;
- With other diseases that are not suitable for participating in clinical research.
Trial locations and contacts
No sites are listed yet.
About this study
Microvascular obstruction is the severe complication of percutaneous coronary intervention (PCI) in patients with acute coronary syndrome. Microvascular obstruction after PCI is often association with poor prognosis. Current treatments do not show improvement in prognosis of microvascular obstruction. Suxiao Jiuxin Pills (SXJX) was shown associated with a reduction in MACE, and an improvement of heart function and quality of life in acute coronary syndrome (ACS) patients with early PCI. To evaluate the effectiveness and safety of SXJX in microvascular obstruction after PCI, the investigators designed this study.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Suxiao Jiuxin Pills, The placebo of Suxiao Jiuxin Pills
- Keywords
- Microvascular obstruction, Acute Coronary Syndrome, Percutaneous coronary intervention, Suxiao Jiuxin Pills
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suxiao Jiuxin PillsDrug
Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).
The placebo of Suxiao Jiuxin PillsDrug
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 180 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 180 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.
Change from baseline myocardial infarct size at 6 months
MI size measure by CMR
Measured: 3-5 days after PCI and 180±7 days
Change from baseline incidence of microvascular obstruction at 6 months
Incidence of Microvascular obstruction measure by CMR
Measured: 3-5 days after PCI and 180±7 days
Secondary outcomes (15)
Change from baseline incidence of intramyocardial hemorrhagex at 6 months
Incidence of intramyocardial hemorrhagex measure by CMR
Measured: 3-5 days after PCI and 180±7 days
Change from baseline incidence of area-at-risk at 6 months
Incidence of area-at-risk measure by CMR
Measured: 3-5 days after PCI and 180±7 days
Change of ST segment in electrocardiogram
Change of ST segment in electrocardiogram
Measured: Baseline, immediately after PCI, 5-7 days after PCI, 30±7 days and 180±7 days
Change of CK-MB
CK-MB
Measured: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Change of cTnI
cTnI
Measured: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Change of NT-proBNP
NT-proBNP
Measured: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Change of ejection fraction in echocardiography
Ejection fraction measure by echocardiography
Measured: Baseline, 3-5 days after PCI and 180±7 days
Change of 6 Minute Walk Test
6MWT is used to assess aerobic capacity and endurance
Measured: 3-5 days after PCI, 30±7 days and 180±7 days
Quantitative flow ratio
Index measure by QFR
Measured: During the procedure
Incidence of MACCE
Cardiac death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization and re-hospitalization for heart failure
Measured: Through study completion, an average of 1 year
Incidence of complications of PCI
Cardiac shock, heart failure, mechanical complications and arrhythmia
Measured: Up to 1 month
Incidence of bleeding event
BARC Type 3 or 4
Measured: Up to 6 months
Incidence of stent restenosis
stent restenosis measure by CMR
Measured: 180±7 days
Incidence of death event
Any death
Measured: Through study completion, an average of 1 year
Change of Seattle Angina Questionnaire (SAQ)
Seattle Angina Questionnaire (SAQ), the scale has 19 questions, value of each question is from 1 to 6, higher scores mean a better outcome.
Measured: baseline, 3-5 days after PCI, 30±7 days, 90±7 days and 180±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 May 2021 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814121
- Sponsor's protocol ID
- 2020KT1715
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suxiao Jiuxin Pills in Microvascular Obstruction in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04814121
- Acronym / sponsor ID
- 2020KT1715
- Conditions
- Acute Coronary Syndrome
- Keywords
- Microvascular obstruction, Acute Coronary Syndrome, Percutaneous coronary intervention, Suxiao Jiuxin Pills
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 24 Mar 2021 (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.
Microvascular obstruction is the severe complication of percutaneous coronary intervention (PCI) in patients with acute coronary syndrome. Microvascular obstruction after PCI is often association with poor prognosis. Current treatments do not show improvement in prognosis of microvascular obstruction. Suxiao Jiuxin Pills (SXJX) was shown associated with a reduction in MACE, and an improvement of heart function and quality of life in acute coronary syndrome (ACS) patients with early PCI. To evaluate the effectiveness and safety of SXJX in microvascular obstruction after PCI, the investigators designed this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| 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 180 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 180 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet the diagnosis of AMI, prepare for PCI reperfusion therapy;
- Between the ages of 18-75;
- Volunteer to participate in this study and have signed an informed consent form;
- Have a correct understanding of the significance of drug research, and have a good compliance with the observation and evaluation.
Key exclusion criteria (16 listed)
- Not suitable for coronary intervention;
- With unstable hemodynamics;
- Platelet count<100×109;
- Suspected aortic dissection or acute pulmonary embolism;
- With mechanical complications;
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 PillsSuxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian). | Drug | Suxiao Jiuxin Pills |
| The placebo of Suxiao Jiuxin PillsThe 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
Change from baseline myocardial infarct size at 6 months
Time frame: 3-5 days after PCI and 180±7 days
MI size measure by CMR
Change from baseline incidence of microvascular obstruction at 6 months
Time frame: 3-5 days after PCI and 180±7 days
Incidence of Microvascular obstruction measure by CMR
15 secondary outcomes
Change from baseline incidence of intramyocardial hemorrhagex at 6 months
Time frame: 3-5 days after PCI and 180±7 days
Change from baseline incidence of area-at-risk at 6 months
Time frame: 3-5 days after PCI and 180±7 days
Change of ST segment in electrocardiogram
Time frame: Baseline, immediately after PCI, 5-7 days after PCI, 30±7 days and 180±7 days
Change of CK-MB
Time frame: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Change of cTnI
Time frame: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Change of NT-proBNP
Time frame: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Change of ejection fraction in echocardiography
Time frame: Baseline, 3-5 days after PCI and 180±7 days
Change of 6 Minute Walk Test
Time frame: 3-5 days after PCI, 30±7 days and 180±7 days
Quantitative flow ratio
Time frame: During the procedure
Incidence of MACCE
Time frame: Through study completion, an average of 1 year
Incidence of complications of PCI
Time frame: Up to 1 month
Incidence of bleeding event
Time frame: Up to 6 months
Incidence of stent restenosis
Time frame: 180±7 days
Incidence of death event
Time frame: Through study completion, an average of 1 year
Change of Seattle Angina Questionnaire (SAQ)
Time frame: baseline, 3-5 days after PCI, 30±7 days, 90±7 days and 180±7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suxiao Jiuxin Pills in people with Acute Coronary Syndrome, run by Guangzhou University of Traditional Chinese Medicine.
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 16 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 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minzhou Zhang, Professor (+86-13924266368, minzhouzhang@gzucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline myocardial infarct size at 6 months (time frame: 3-5 days after PCI and 180±7 days). The study lists 2 primary outcomes in all. 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 24 Mar 2021.