Coronary Microvascular DiseasePhase 4NCT04220372
Tongxinluo Capsule for Coronary Microvascular Disease
A Phase 4 study testing Tongxinluo in people with Coronary Microvascular Disease, run by Qilu Hospital of Shandong University.
Trial summary
To investigate the efficacy and safety of Tongxinluo in patients with microvascular angina pectoris. Long-term follow-up of 1 to 5 years will be performed to evaluate the effect of Tongxinluo on long-term adverse cardiovascular events in patients with coronary microvascular disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Microvascular Disease
- What is being tested?
- Tongxinluo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jan 2025
- 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
- Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
- Coronary normal or stenosis < 20%;
- Ischemic depression in ST segment during resting or exercise;
- Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;
- Subjects or their guardians agreed to participate in this study.
Who cannot join
- Previous myocardial infarction or PCI or CABG treatment;
- A history of heart failure or LVEF < 50%;
- Severe arrhythmia;
- Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
- A history of stroke within half a year;
- Diabetes difficult to control;
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- Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm;
- Familial hypercholesterolemia;
- Takayasu arteritis, Kawasaki disease or coronary artery malformation;
- Pregnant or nursing, or having the intention to give birth within one year;
- Hepatic or renal dysfunction;
- Other diseases which may cause serious risks to patients;
- Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;
- Allergic to contrast agents or blood products;
- Patients who participated in clinical research of other drugs within 3 months before being selected.
About this study
Official title: The Efficacy and Safety of Tongxinluo Capsule in Patients With Coronary Microvascular Disease
To investigate the efficacy and safety of Tongxinluo in patients with microvascular angina pectoris. Long-term follow-up of 1 to 5 years will be performed to evaluate the effect of Tongxinluo on long-term adverse cardiovascular events in patients with coronary microvascular disease.
- Conditions
- Coronary Microvascular Disease
- Being tested
- Tongxinluo, Placebo
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TongxinluoDrug
Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD
PlaceboDrug
Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD
| Study group | Role | What they receive |
|---|---|---|
| Tongxinluo Capsule | Experimental | Not described Receives: Drug: Tongxinluo |
| Placebo Capsule | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Coronary Flow Reserve
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DiseaseStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan-Pan Hao, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220372
- Sponsor's protocol ID
- Tongxinluo and CMVD
- Status last verified
- Jan 2020
- First submitted
- 5 Jan 2020
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Tongxinluo Capsule in Patients With Coronary Microvascular Disease
- ClinicalTrials.gov ID
- NCT04220372
- Acronym / sponsor ID
- Tongxinluo and CMVD
- Conditions
- Coronary Microvascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 7 Jan 2020 (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.
To investigate the efficacy and safety of Tongxinluo in patients with microvascular angina pectoris. Long-term follow-up of 1 to 5 years will be performed to evaluate the effect of Tongxinluo on long-term adverse cardiovascular events in patients with coronary microvascular disease.
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 |
|---|---|---|
| Tongxinluo Capsule | Experimental | Drug: Tongxinluo |
| Placebo Capsule | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
- Coronary normal or stenosis < 20%;
- Ischemic depression in ST segment during resting or exercise;
- Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;
- Subjects or their guardians agreed to participate in this study.
Key exclusion criteria (15 listed)
- Previous myocardial infarction or PCI or CABG treatment;
- A history of heart failure or LVEF < 50%;
- Severe arrhythmia;
- Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
- A history of stroke within half a year;
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 |
|---|---|---|
| TongxinluoProvided by Shijiazhuang Yiling Pharmaceutical CO., LTD | Drug | Tongxinluo Capsule |
| PlaceboProvided by Shijiazhuang Yiling Pharmaceutical CO., LTD | Drug | Placebo Capsule |
Primary outcome
Changes of Coronary Flow Reserve
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tongxinluo in people with Coronary Microvascular Disease, run by Qilu Hospital of Shandong University.
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 5 inclusion and 15 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 7 Jan 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Coronary Flow Reserve (time frame: 1 year). 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 7 Jan 2020.