Angina, StablePhase 4NCT02280850
Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina
A Phase 4 study testing Guanxin Shutong Capsule and nitroglycerine in people with Angina, Stable, run by Shaanxi Buchang Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
Compared with placebo, assess of the efficacy and safety of Guanxin Shutong capsule to treat chronic stable angina (syndrome of blood stasis resistance), and the result will be used for the basis of later Ⅳ clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Angina, Stable
- What is being tested?
- Guanxin Shutong Capsule and nitroglycerine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Oct 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptom of chronic stable angina is sustained for 3 months or over 3 months (typical symptoms of myocardial ischemia occurred at least 2 times in the latest week, and angina type is stable angina (Canada CCS class Ⅰ、Ⅱ or Ⅲ);
- Blood stasis resistance on traditional Chinese medicine syndrome differentiation;
- Patients who meet the following any situation:
- had coronary angiography and verified a least one main branch of coronary stenosis ≥50%;
- have typical angina symptom, and also have positive ETT result or CTA shows at least one main branch of coronary stenosis ≥50%;
- had history of myocardial infarct (at least 6 months).
- Written informed consent.
Who cannot join
- Acute coronary syndrome or highly suspected acute coronary syndrome;
- Variant angina or unstable angina;
- Myocardial infarction within the past 6 months;
- Left main disease and without revascularization was verified through angiography or CTA;
- Moderate to severe aortic stenosis, hypertrophic Obstructive Cardiomyopathy or congestive heart-failure (NYHA class Ⅲ-Ⅳ);
- Patients who were received PCI/CABG within 1 year;
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- Patients who are poor control of high blood pressure (SBP>170mmHg, or DBP>100mmHg);
- Patients who have hypotension (SBP<90mmHg, DBP<60mmHg) or had orthostatic hypotension;
- ECG shows complete left bundle branch block, pre-excitation syndrome, left ventricular hypertrophy or pacemaker rhythm;
- Hypohepatia (ALT or bilirubin level is higher than upper limit), renal insufficiency (serum creatinine level is higher than upper limit);
- Active peptic ulcer or skin ulcer;
- Diagnosed chest pain caused by severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, gallbladder-cardiac syndrome, gastroesophageal reflux, esophageal hiatus hernia or in aortic dissection;
- Patients had hematological disorder, specific bleeding or warfarin caused bleeding;
- Drug abuser, patients with history of alcoholism in the past 2 years or dependency to known drugs;
- Psychopath;
- Patients who can't compelet exercise test (note: just for partial patients who need to complete exercise test);
- Pregnancy or lactation;
- Patients who are known or suspected hypersensitive to the study medicine or allergic constitution;
- Patients who were received big surgery within 4 weeks or participated in other clinical trials within 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, 110045
Han Yaling, Academician, +86-24-28856123, guanxinshutong@126.com
About this study
Official title: Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina: A Randomised, Double-blind, Placebo-controlled Clinical Trial
Compared with placebo, assess of the efficacy and safety of Guanxin Shutong capsule to treat chronic stable angina (syndrome of blood stasis resistance), and the result will be used for the basis of later Ⅳ clinical trial.
Read the detailed description
- Procedures 1.1 Start-up stage (-14~0 Day)
- Inquire medical history, medication use, accompanied treatment, etc;
- Sign informed consent;
- Measure vital signs and conduct physical examination;
- Record symptom and signs;
- Confirm inclusion/exclusion criteria, and put patients who meet inclusion criteria into start-up stage;
- Record participators' history of angina pectoris and treatment, or select stable angina from outpatient service (without medicate);
- Allocate screen number, hand out Guanxi Shutong Capsules Placebo and record card of angina/nitroglycerin used;
- Advise patient return visit with an empty belly 2 weeks later. 1.2 Interview 1 (Baseline 0 Day) (1) Measure vital signs; (2)Accomplish all the examination items: Blood routines, Urine routines, Stool routines + Occult blood, Hepatorenal function (AST, ALT, TBIL, ALP, γ-GT, BUN, Cr), Four coagulation tests (TT, PT, APTT, FIB), Blood fat (TC, TG, HDL-C, LDL-C), 12 leads electrocardiogram, Seattle Angina Ques-tionnaire (SAQ). Additionally, premenopausal women receive urine pregnancy test; (3) Exercise treadmill testing (ETT): around am. 10:00 (Note: Just for the patients who need ETT); (4) Record symptoms and signs ( Score of syndrome of Chinese medicine and Score of angina); (5) Randomize and allocate drug number; (6) Hand out the drugs for 2 weeks and record card of angina/nitroglycerin used; (7) Advise patient return visit 2 weeks later. 1.3 Interview 2 (14±2 Day)
- Inquire adverse events;
- Inquire accompanied treatment and record combined medication.
- Measure vital signs;
- Record symptoms and signs (Score of syndrome of Chinese medicine and Score of angina);
- Withdraw remained drugs and box, and record card;
- Hand out the drugs for 2 weeks and record card of angina/nitroglycerin used;
- Advise patient return visit 2 weeks later. 1.4 Interview 3 (28±2 Day) (1) Inquire adverse events; (2) Inquire accompanied treatment and record combined medication. (3) Measure vital signs; (4) Record symptoms and signs (Score of syndrome of Chinese medicine and Score of angina); (5) 12 leads electrocardiogram (6) Accomplish all the examination items: Blood routines, Urine routines, Stool routines + Occult blood, Hepatorenal function (AST, ALT, TBIL, ALP, γ-GT, BUN, Cr), Four coagulation tests (TT, PT, APTT, FIB), Blood fat (TC, TG, HDL-C, LDL-C), 12 leads electrocardiogram, Seattle Angina Ques-tionnaire (SAQ); (7) Exercise treadmill testing (ETT) (Note: Just for the patients who need ETT); (8) Withdraw remained drugs and box, and record card; (9) Assess compliance; (10) Summarize the clinical trial.
- Conditions
- Angina, Stable
- Being tested
- Guanxin Shutong Capsule, Placebo Capsule, nitroglycerine
- Keywords
- Angina
- Medical subject headings
- Angina, Stable, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guanxin Shutong CapsuleDrug
3 capsules three times a day; Duration: 4 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
Placebo CapsuleDrug
3 capsules three times a day; Duration: 4 weeks.
nitroglycerineDrug
Adults: 0.25mg-0.5mg (half pill or 1 pill) once, sub-lingual. One more pill per 5 minutes untill pain relief. If total dose is 3 pills in 15 minutes and the pain is still in, please seek medical advice urgently.
The participators in both arms who have agina symptom will take Nitroglycerine. So the accumulated consumption of participators is the one of the maesuremnts.
| Study group | Role | What they receive |
|---|---|---|
| Guanxin Shutong Capsule | Experimental | 3 capsules once, tid, Oral Duration: 4 weeks Receives: Drug: Guanxin Shutong Capsule; Drug: nitroglycerine |
| Placebo Capsule | Placebo comparator | Placebo capsule and Guanxin Shutong Capsule the same appearance are made by SHAANXI BUCHANG PHARMACEUTICAL CO.,LTD.
3 capsules once, tid, Oral Duration: 4 weeks Receives: Drug: Placebo Capsule; Drug: nitroglycerine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic effect to Angina ( Average value of angina frequency)
Record angina frequency per week. Record date is Start-up Stage 1st week, Start-up Stage 2st week, Interview Stage 1st week, Interview Stage 2st week, Interview Stage 3st week and Interview Stage 4st week (Toal of 6 times).
Measured: 6 weeks
Exercise treadmill testing (ETT)
ST-segment displacement in electrocardiogram: Observe ST-segment displacement of J point after 60ms, including the degree of ST-segment depression.
Measured: 4 weeks
Secondary outcomes (6)
Usage of nitroglycerine per day (average value)
Measured: 4 weeks
Seattle Angina Ques-tionnaire (SAQ)
Measured: 4 weeks
Scores on Chinese medical syndrome scale
Primary symptom: Chest pains (0; Slight: 2; Moderate: 4; Severe: 6) Chest congestion (0; Slight: 2; Moderate: 4; Severe: 6) Secondary symptom: Palpitation (0; Slight: 1; Moderate: 2; Severe: 3) Shortness of breath (0; Slight: 1; Moderate: 2; Severe: 3) Insomnia (0; Slight: 1; Moderate: 2; Severe: 3)
Measured: 4 weeks
Electrocardiogram manifestation
Compare the changes of electrocardiogram manifestation (such as ST segment, T wave) of angina before and after treatment.
Measured: 4 weeks
Time of angina break out from exercise beginning in ETT
Measured: 4 weeks
Time of ST below 1 mm from exercise beginning in ETT
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015 (estimated)
- Study completionOct 2015 (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 Angina, StableStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Buchang Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lv Shuzheng, Principal investigator, Beijing Anzhen HospitalZhang Yan, Principal investigator, The Affiliated Hospital of Liaoning Hospital of Traditional Chinese MedicineChen Bojun, Principal investigator, The Second Affiliated Hospital of Guangzhou University of Traditional Chinese MedicineLuo Wei, Principal investigator, Xuzhou Central HospitalJiang Binghua, Principal investigator, Shandong University of Traditional Chinese MedicineZhang Zhenxian, Principal investigator, Luohe Hospital of Traditional Chinese MedicineXing Yanjun, Principal investigator, First Hospital of Shijiazhuang City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280850
- Sponsor's protocol ID
- YL-CTP-Z20020055
- Status last verified
- Oct 2014
- First submitted
- 23 Oct 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Li Y, Zhang L, Lv S, Wang X, Zhang J, Tian X, Zhang Y, Chen B, Liu D, Yang J, Dong P, Xu Y, Song Y, Shi J, Li L, Wang X, Han Y. Efficacy and safety of oral Guanxinshutong capsules in patients with stable angina pectoris in China: a prospective, multicenter, double-blind, placebo-controlled, randomized clinical trial. BMC Complement Altern Med. 2019 Dec 11;19(1):363. doi: 10.1186/s12906-019-2778-z.
PubMed 31829173
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina: A Randomised, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02280850
- Acronym / sponsor ID
- YL-CTP-Z20020055
- Conditions
- Angina, Stable
- Keywords
- Angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shaanxi Buchang Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 3 Nov 2014 (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.
Compared with placebo, assess of the efficacy and safety of Guanxin Shutong capsule to treat chronic stable angina (syndrome of blood stasis resistance), and the result will be used for the basis of later Ⅳ clinical trial.
Detailed description
- Procedures 1.1 Start-up stage (-14~0 Day)
- Inquire medical history, medication use, accompanied treatment, etc;
- Sign informed consent;
- Measure vital signs and conduct physical examination;
- Record symptom and signs;
- Confirm inclusion/exclusion criteria, and put patients who meet inclusion criteria into start-up stage;
- Record participators' history of angina pectoris and treatment, or select stable angina from outpatient service (without medicate);
- Allocate screen number, hand out Guanxi Shutong Capsules Placebo and record card of angina/nitroglycerin used;
- Advise patient return visit with an empty belly 2 weeks later. 1.2 Interview 1 (Baseline 0 Day) (1) Measure vital signs; (2)Accomplish all the examination items: Blood routines, Urine routines, Stool routines + Occult blood, Hepatorenal function (AST, ALT, TBIL, ALP, γ-GT, BUN, Cr), Four coagulation tests (TT, PT, APTT, FIB), Blood fat (TC, TG, HDL-C, LDL-C), 12 leads electrocardiogram, Seattle Angina Ques-tionnaire (SAQ). Additionally, premenopausal women receive urine pregnancy test; (3) Exercise treadmill testing (ETT): around am. 10:00 (Note: Just for the patients who need ETT); (4) Record symptoms and signs ( Score of syndrome of Chinese medicine and Score of angina); (5) Randomize and allocate drug number; (6) Hand out the drugs for 2 weeks and record card of angina/nitroglycerin used; (7) Advise patient return visit 2 weeks later. 1.3 Interview 2 (14±2 Day)
- Inquire adverse events;
- Inquire accompanied treatment and record combined medication.
- Measure vital signs;
- Record symptoms and signs (Score of syndrome of Chinese medicine and Score of angina);
- Withdraw remained drugs and box, and record card;
- Hand out the drugs for 2 weeks and record card of angina/nitroglycerin used;
- Advise patient return visit 2 weeks later. 1.4 Interview 3 (28±2 Day) (1) Inquire adverse events; (2) Inquire accompanied treatment and record combined medication. (3) Measure vital signs; (4) Record symptoms and signs (Score of syndrome of Chinese medicine and Score of angina); (5) 12 leads electrocardiogram (6) Accomplish all the examination items: Blood routines, Urine routines, Stool routines + Occult blood, Hepatorenal function (AST, ALT, TBIL, ALP, γ-GT, BUN, Cr), Four coagulation tests (TT, PT, APTT, FIB), Blood fat (TC, TG, HDL-C, LDL-C), 12 leads electrocardiogram, Seattle Angina Ques-tionnaire (SAQ); (7) Exercise treadmill testing (ETT) (Note: Just for the patients who need ETT); (8) Withdraw remained drugs and box, and record card; (9) Assess compliance; (10) Summarize the clinical trial.
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 |
|---|---|---|
| Guanxin Shutong Capsule | Experimental | Drug: Guanxin Shutong Capsule, Drug: nitroglycerine3 capsules once, tid, Oral Duration: 4 weeks |
| Placebo Capsule | Placebo comparator | Drug: Placebo Capsule, Drug: nitroglycerinePlacebo capsule and Guanxin Shutong Capsule the same appearance are made by SHAANXI BUCHANG PHARMACEUTICAL CO.,LTD. 3 capsules once, tid, Oral Duration: 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Symptom of chronic stable angina is sustained for 3 months or over 3 months (typical symptoms of myocardial ischemia occurred at least 2 times in the latest week, and angina type is stable angina (Canada CCS class Ⅰ、Ⅱ or Ⅲ);
- Blood stasis resistance on traditional Chinese medicine syndrome differentiation;
- Patients who meet the following any situation:
- Written informed consent.
Key exclusion criteria (19 listed)
- Acute coronary syndrome or highly suspected acute coronary syndrome;
- Variant angina or unstable angina;
- Myocardial infarction within the past 6 months;
- Left main disease and without revascularization was verified through angiography or CTA;
- Moderate to severe aortic stenosis, hypertrophic Obstructive Cardiomyopathy or congestive heart-failure (NYHA class Ⅲ-Ⅳ);
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 |
|---|---|---|
| Guanxin Shutong Capsule3 capsules three times a day; Duration: 4 weeks. Number of Cycles: until progression or unacceptable toxicity develops. | Drug | Guanxin Shutong Capsule |
| Placebo Capsule3 capsules three times a day; Duration: 4 weeks. | Drug | Placebo Capsule |
| nitroglycerineAdults: 0.25mg-0.5mg (half pill or 1 pill) once, sub-lingual. One more pill per 5 minutes untill pain relief. If total dose is 3 pills in 15 minutes and the pain is still in, please seek medical advice urgently. The participators in both arms who have agina symptom will take Nitroglycerine. So the accumulated consumption of participators is the one of the maesuremnts. | Drug | Guanxin Shutong Capsule, Placebo Capsule |
Primary outcome
Therapeutic effect to Angina ( Average value of angina frequency)
Time frame: 6 weeks
Record angina frequency per week. Record date is Start-up Stage 1st week, Start-up Stage 2st week, Interview Stage 1st week, Interview Stage 2st week, Interview Stage 3st week and Interview Stage 4st week (Toal of 6 times).
Exercise treadmill testing (ETT)
Time frame: 4 weeks
ST-segment displacement in electrocardiogram: Observe ST-segment displacement of J point after 60ms, including the degree of ST-segment depression.
6 secondary outcomes
Usage of nitroglycerine per day (average value)
Time frame: 4 weeks
Seattle Angina Ques-tionnaire (SAQ)
Time frame: 4 weeks
Scores on Chinese medical syndrome scale
Time frame: 4 weeks
Electrocardiogram manifestation
Time frame: 4 weeks
Time of angina break out from exercise beginning in ETT
Time frame: 4 weeks
Time of ST below 1 mm from exercise beginning in ETT
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
- Derived from this study: PubMed 31829173Li Y, Zhang L, Lv S, Wang X, Zhang J, Tian X, Zhang Y, Chen B, Liu D, Yang J, Dong P, Xu Y, Song Y, Shi J, Li L, Wang X, Han Y. Efficacy and safety of oral Guanxinshutong capsules in patients with stable angina pectoris in China: a prospective, multicenter, double-blind, placebo-controlled, randomized clinical trial. BMC Complement Altern Med. 2019 Dec 11;19(1):363. doi: 10.1186/s12906-019-2778-z.
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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.
Lv Shuzheng principal investigator
Beijing Anzhen Hospital
Zhang Yan principal investigator
The Affiliated Hospital of Liaoning Hospital of Traditional Chinese Medicine
Chen Bojun principal investigator
The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
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 Guanxin Shutong Capsule and nitroglycerine in people with Angina, Stable, run by Shaanxi Buchang Pharmaceutical Co., Ltd 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 7 inclusion and 19 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 3 Nov 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 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 Han Yaling, Academician (+86-24-28856123, guanxinshutong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic effect to Angina ( Average value of angina frequency) (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT02280850, 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 3 Nov 2014.