Coronary Heart DiseasePhase 2NCT01615003
The Study of MicroRNA Genomics of Blood Stasis Syndrome and of Coronary Heart Disease
A Phase 2 study testing Xuesaitong soft capsule in people with Coronary Heart Disease and Unstable Angina, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
In this study, typical cases of blood stasis syndrome of coronary heart disease are selected, by using microRNA chip, cDNA microarray and other bioinformatics technologies to filter and verify related miRNA and its target gene of 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, Blood Stasis Syndrome
- 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
- May 2012to Dec 2014
- 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
- Tongue dark
- 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'an men Hispital
Beijing, Beijing Municipality, 100000
Fei Teng, master, 13581985462, echo-teng@126.com
Gui Yu, master, 13488835663
About this study
Official title: The Analysis of Blood Stasis Syndromeand of Coronary Heart Disease Related MicroRNA Genomics and Target Gene Regulatory Networks
In this study, typical cases of blood stasis syndrome of coronary heart disease are selected, by using microRNA chip, cDNA microarray and other bioinformatics technologies to filter and verify related miRNA and its target gene of Coronary Heart disease. Meanwhile, intervene by Xuesaitong soft capsules to investigate related miRNA and its target gene of Coronary Heart disease.
- Being tested
- Xuesaitong soft capsule, Xuesaitong soft capsule Placebo
- Keywords
- MicroRNA, coronary heart disease, unstable angina, blood stasis syndrome, Xuesaitong soft 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
Xuesaitong soft capsule, soft capsule, Ingredients:PNS, Specification:0.33 per bag, once take two pills and twice a day during a month.
Xuesaitong soft capsule PlaceboDrug
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 |
| control group | 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: Xuesaitong soft capsule Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina
The change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina by real RT-PCR.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615003
- Sponsor's protocol ID
- NNSF81173116
- Status last verified
- Jan 2014
- First submitted
- 28 May 2012
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of Blood Stasis Syndromeand of Coronary Heart Disease Related MicroRNA Genomics and Target Gene Regulatory Networks
- ClinicalTrials.gov ID
- NCT01615003
- Acronym / sponsor ID
- NNSF81173116
- Keywords
- MicroRNA, coronary heart disease, unstable angina, blood stasis syndrome, Xuesaitong soft capsule
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Jun 2012 (estimated)
- 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 blood stasis syndrome of coronary heart disease are selected, by using microRNA chip, cDNA microarray and other bioinformatics technologies to filter and verify related miRNA and its target gene of Coronary Heart disease. Meanwhile, intervene by Xuesaitong soft capsules to investigate related miRNA and its target gene of Coronary Heart 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 |
|---|---|---|
| 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. |
| control group | Placebo comparator | Drug: Xuesaitong soft capsule PlaceboPatients 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 (6 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
- Tongue dark
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 capsuleXuesaitong soft capsule, soft capsule, Ingredients:PNS, Specification:0.33 per bag, once take two pills and twice a day during a month. | Drug | Xuesaitong soft capsule group |
| Xuesaitong soft capsule PlaceboXuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month. | Drug | control group |
Primary outcome
the change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina
Time frame: 1 month
The change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina by real RT-PCR.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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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.
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 Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 6 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 14 Jan 2014. 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 Fei Teng, master (13581985462, echo-teng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina (time frame: 1 month). 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 14 Jan 2014.