Coronary Heart DiseasePhase 2NCT03083119
Efficacy and Safety of Xuesaitong Soft Capsule for Coronary Heart Disease Unstable Angina
A Phase 2 study testing Xuesaitong soft capsule in people with Coronary Heart Disease and Unstable Angina, run by Jie Wang at 1 site in China.
Trial summary
In this study, typical cases of coronary heart disease are selected. They will be intervened by Xuesaitong soft capsules to investigate efficacy and safety for Coronary Heart disease. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Coronary Heart Disease, Unstable Angina
- What is being tested?
- Xuesaitong soft capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2017to 20 Aug 2017
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of coronary angiography unstable angina
- Clinical diagnosis of unstable angina
- Age of 30 to 75 years old
- Not use thrombolysis, dilate coronary drugs within two weeks
- Sign the consent
Who cannot join
- Severe valvular heart disease
- Insulin-dependent diabetes
- mental disease
- Combined with severe liver, kidney, hematopoietic system disorder
- Patients with malignant tumors
- Pregnancy or breast-feeding women
- Recent history of trauma
- Drug allergy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang Anmen Hospital
Beijing, Beijing Municipality, 100029
Lian Duan, +8601088001817, popale2003@163.com
About this study
Official title: The Methylation Regulation Mechanism of Blood Stasis Relevant miRNA Expression on Coronary Heart Disease
In this study, typical cases of coronary heart disease are selected. They will be intervened by Xuesaitong soft capsules to investigate efficacy and safety for Coronary Heart disease.
- Conditions
- Coronary Heart Disease, Unstable Angina
- Being tested
- Xuesaitong soft capsule, Placebo oral capsule
- Medical subject headings
- Coronary Disease, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xuesaitong soft capsuleDrug
Panax Notoginseng Saponins, Specification:0.33 per bag, once take two pills and twice a day during a month.
Placebo oral capsuleDrug
Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.
| Study group | Role | What they receive |
|---|---|---|
| Xuesaitong soft capsule group | Experimental | Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and Xuesaitong soft capsule. Receives: Drug: Xuesaitong soft capsule |
| Placebo Comparator | Placebo comparator | Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and placebo. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events
death, myocardial infarction, hospitalization for unstable angina or stroke
Measured: 60 days
Seattle Angina Questionnaire
to evaluate patients by Seattle Angina Questionnaire
Measured: 60 days
blood stasis syndrome scale of Coronary heart disease angina pectoris
to evaluate patients by blood stasis syndrome scale of Coronary heart disease angina pectoris
Measured: 60
Secondary outcomes (1)
lipid
Triacylglyceride,total cholesterol, low densith lipoprotein, high densith lipoprotein
Measured: 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start20 Mar 2017 (estimated)
- Primary completion20 Apr 2017 (estimated)
- Study completion20 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jie Wang, Principal investigator, Guang Anmen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083119
- Sponsor's protocol ID
- 81473561
- Status last verified
- Mar 2017
- First submitted
- 13 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Duan L, Liu Y, Li J, Zhang Y, Dong Y, Liu C, Wang J. Panax notoginseng Saponins Alleviate Coronary Artery Disease Through Hypermethylation of the miR-194-MAPK Pathway. Front Pharmacol. 2022 Jun 16;13:829416. doi: 10.3389/fphar.2022.829416. eCollection 2022.
PubMed 35784716
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Methylation Regulation Mechanism of Blood Stasis Relevant miRNA Expression on Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT03083119
- Acronym / sponsor ID
- 81473561
- Conditions
- Coronary Heart Disease, Unstable Angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Jie WangUniversity, hospital or other
- Study start
- 20 Mar 2017 (estimated)
- Primary completion
- 20 Apr 2017 (estimated)
- Study completion
- 20 Aug 2017 (estimated)
- First posted
- 17 Mar 2017 (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.
In this study, typical cases of coronary heart disease are selected. They will be intervened by Xuesaitong soft capsules to investigate efficacy and safety for Coronary Heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xuesaitong soft capsule group | Experimental | Drug: Xuesaitong soft capsulePatients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and Xuesaitong soft capsule. |
| Placebo Comparator | Placebo comparator | Drug: Placebo oral capsulePatients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and placebo. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of coronary angiography unstable angina
- Clinical diagnosis of unstable angina
- Age of 30 to 75 years old
- Not use thrombolysis, dilate coronary drugs within two weeks
- Sign the consent
Key exclusion criteria (8 listed)
- Severe valvular heart disease
- Insulin-dependent diabetes
- mental disease
- Combined with severe liver, kidney, hematopoietic system disorder
- Patients with malignant tumors
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 |
|---|---|---|
| Xuesaitong soft capsulePanax Notoginseng Saponins, Specification:0.33 per bag, once take two pills and twice a day during a month. | Drug | Xuesaitong soft capsule group |
| Placebo oral capsuleXuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month. | Drug | Placebo Comparator |
Primary outcome
major adverse cardiovascular events
Time frame: 60 days
death, myocardial infarction, hospitalization for unstable angina or stroke
Seattle Angina Questionnaire
Time frame: 60 days
to evaluate patients by Seattle Angina Questionnaire
blood stasis syndrome scale of Coronary heart disease angina pectoris
Time frame: 60
to evaluate patients by blood stasis syndrome scale of Coronary heart disease angina pectoris
1 secondary outcome
lipid
Time frame: 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Derived from this study: PubMed 35784716Duan L, Liu Y, Li J, Zhang Y, Dong Y, Liu C, Wang J. Panax notoginseng Saponins Alleviate Coronary Artery Disease Through Hypermethylation of the miR-194-MAPK Pathway. Front Pharmacol. 2022 Jun 16;13:829416. doi: 10.3389/fphar.2022.829416. eCollection 2022.
- 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.
Jie Wang principal investigator
Guang Anmen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xuesaitong soft capsule in people with Coronary Heart Disease and Unstable Angina, run by Jie Wang 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 5 inclusion and 8 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 17 Mar 2017. 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 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 Lian Duan (+8601088001817, popale2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiovascular events (time frame: 60 days). The study lists 3 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 NCT03083119, which also lists 1 linked publication.
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 17 Mar 2017.