Unstable AnginaPhase 4NCT03037047
Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris
A Phase 4 study testing 0.9% Sodium Chloride Injection and salvianolate injection in people with Unstable Angina, run by Green Valley Group of China at 1 site in China.
Trial summary
This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Unstable Angina
- What is being tested?
- 0.9% Sodium Chloride Injection and salvianolate injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2016to 31 Dec 2018
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient in line with 1979 WHO diagnostic criteria for UA
- Ages eligible for study: 60-85years (adult,senior)
- Traditional Chinese medicine for CHD treatment should be stopped at least 1 week;take CHD drugs standardly
- Participates give written informed consent
Who cannot join
- NSTE-ACS caused by non atherosclerotic disease
- Angina pectoris caused by violent activities, fever, tachycardia, high adrenergic state, mental stress, lack of sleep, eating too full, left ventricular load increased (hypertension, aortic stenosis)
- Angina pectoris caused byanemia, methemoglobinemia and hypoxemia
- Abnormal thyroid function
- Poorly controlled hypertension (systolic pressure ≥160mmHg or diastolic blood pressure ≥100mmHg)
- Severe cardiopulmonary dysfunction
Show all 12Show fewer
- Severe arrhythmia (atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, sinus bradycardia (heart rate < 55),complete left bundle branch block
- Combined liver and kidney and hematopoietic system and other serious diseases, liver function (ALT, AST) 3 times higher than the upper limit of normal renal function, creatinine clearance rate (CrCl) less than 30 ml/min/1.73m2
- Recent 4 weeks underwent surgery and bleeding tendency
- Poor compliance
- At the same time in other clinical researches
- Allergic constitution
Trial locations and contacts
1 site in 1 country.
Hongying Liu, doctor contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospita
Beijing, Beijing Municipality, 100853
Hongying Liu, doctor, +86 10 68182255, xiaowanzi010@163.com
Xiaoying Li, doctor
About this study
Official title: Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris: a Parallel, Double Blind, Randomized, Controlled, Multi-center Trial.
This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris.
Read the detailed description
This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris. Patients will treated with or without salvianolate injection on the basis of conventional therapy for 14 days. The primary measures of effectiveness include the change from baseline to the end of treatment in the angina scores.(Angina score table :sum of 4 items), the variation of EKG (level of the S-T segment)., Additional measures of effectiveness include the change from baseline to the end of the treatment in the Seattle Angina Questionnaire(SAQ),EuroQol-5 Dimensions(EQ-5D) will be performed throughout the study. Patients who complete the double-blind portion of the study will be followed up 28 days. Effectiveness will be assessed at 7 days, 14 days and 28 days. Safety evaluations (incidence of adverse events,, physical examinations, laboratory tests) will be performed at at 7 days, 14 days and 28 days of the study.
- Conditions
- Unstable Angina
- Being tested
- 0.9% Sodium Chloride Injection, salvianolate injection
- Medical subject headings
- Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Sodium Chloride InjectionDrug
Also called Normal saline
Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.
salvianolate injectionDrug
Also called Salvianolate
Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | patients will be treated by 0.9% sodium chloride injection on the basis of conventional therapy for 14 days. Receives: Drug: 0.9% Sodium Chloride Injection |
| Experimental group | Experimental | patients will be treated by salvianolate injection on the basis of conventional therapy for 14 days. Receives: Drug: salvianolate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom of angina pectoris
Measured: up to 14 days
Secondary outcomes (4)
Seattle angina scale score
Measured: up to 28 days
EQ-5D health scale
Measured: up to 28 days
thrombolysis in myocardial infarction risk score
Measured: up to 28 days
Incidence of cardiovascular and cerebrovascular events
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start11 May 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2018 (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 Unstable AnginaStudies 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Valley Group of China
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoying Li, doctor, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037047
- Sponsor's protocol ID
- GV-MD-CT201601
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2017
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cui H, Li XY, Gao XW, Lu X, Wu XP, Wang XF, Zheng XQ, Huang K, Liu F, Luo Z, Yuan HS, Sun G, Kong J, Du XH, Zheng J, Liu HY, Zhang WJ. A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population. Chin J Integr Med. 2019 Oct;25(10):728-735. doi: 10.1007/s11655-019-2710-x. Epub 2019 Nov 28.
PubMed 31782009
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris: a Parallel, Double Blind, Randomized, Controlled, Multi-center Trial.
- ClinicalTrials.gov ID
- NCT03037047
- Acronym / sponsor ID
- GV-MD-CT201601
- Conditions
- Unstable Angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Green Valley Group of ChinaIndustry (pharma, biotech, devices)
- Study start
- 11 May 2016 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 31 Jan 2017 (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.
This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris.
Detailed description
This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris. Patients will treated with or without salvianolate injection on the basis of conventional therapy for 14 days. The primary measures of effectiveness include the change from baseline to the end of treatment in the angina scores.(Angina score table :sum of 4 items), the variation of EKG (level of the S-T segment)., Additional measures of effectiveness include the change from baseline to the end of the treatment in the Seattle Angina Questionnaire(SAQ),EuroQol-5 Dimensions(EQ-5D) will be performed throughout the study. Patients who complete the double-blind portion of the study will be followed up 28 days. Effectiveness will be assessed at 7 days, 14 days and 28 days. Safety evaluations (incidence of adverse events,, physical examinations, laboratory tests) will be performed at at 7 days, 14 days and 28 days of the 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 |
|---|---|---|
| Control group | Placebo comparator | Drug: 0.9% Sodium Chloride Injectionpatients will be treated by 0.9% sodium chloride injection on the basis of conventional therapy for 14 days. |
| Experimental group | Experimental | Drug: salvianolate injectionpatients will be treated by salvianolate injection on the basis of conventional therapy for 14 days. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient in line with 1979 WHO diagnostic criteria for UA
- Ages eligible for study: 60-85years (adult,senior)
- Traditional Chinese medicine for CHD treatment should be stopped at least 1 week;take CHD drugs standardly
- Participates give written informed consent
Key exclusion criteria (12 listed)
- NSTE-ACS caused by non atherosclerotic disease
- Angina pectoris caused by violent activities, fever, tachycardia, high adrenergic state, mental stress, lack of sleep, eating too full, left ventricular load increased (hypertension, aortic stenosis)
- Angina pectoris caused byanemia, methemoglobinemia and hypoxemia
- Abnormal thyroid function
- Poorly controlled hypertension (systolic pressure ≥160mmHg or diastolic blood pressure ≥100mmHg)
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 |
|---|---|---|
| 0.9% Sodium Chloride InjectionAlso: Normal salinePatients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days. | Drug | Control group |
| salvianolate injectionAlso: SalvianolatePatients will treated with salvianolate injection on the basis of conventional therapy for 14 days. | Drug | Experimental group |
Primary outcome
symptom of angina pectoris
Time frame: up to 14 days
4 secondary outcomes
Seattle angina scale score
Time frame: up to 28 days
EQ-5D health scale
Time frame: up to 28 days
thrombolysis in myocardial infarction risk score
Time frame: up to 28 days
Incidence of cardiovascular and cerebrovascular events
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Derived from this study: PubMed 31782009Cui H, Li XY, Gao XW, Lu X, Wu XP, Wang XF, Zheng XQ, Huang K, Liu F, Luo Z, Yuan HS, Sun G, Kong J, Du XH, Zheng J, Liu HY, Zhang WJ. A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population. Chin J Integr Med. 2019 Oct;25(10):728-735. doi: 10.1007/s11655-019-2710-x. Epub 2019 Nov 28.
- 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.
Hongying Liu, doctor contact
Xiaoying Li, doctor study chair
Chinese PLA General Hospital
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 0.9% Sodium Chloride Injection and salvianolate injection in people with Unstable Angina, run by Green Valley Group of China 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: status not confirmed, as of the sponsor's last update on 31 Jan 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 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 Hongying Liu, doctor (xiaowanzi010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom of angina pectoris (time frame: up to 14 days). 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 NCT03037047, 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 31 Jan 2017.