Clinical trial NCT02280850: Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina
Official title: Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina: A Randomised, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Angina, Stable
Keywords: Angina
Lead sponsor: Shaanxi Buchang Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2014-11-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 1. Procedures 1.1 Start-up stage (-14\~0 Day)

1. Inquire medical history, medication use, accompanied treatment, etc;
2. Sign informed consent;
3. Measure vital signs and conduct physical examination;
4. Record symptom and signs;
5. Confirm inclusion/exclusion criteria, and put patients who meet inclusion criteria into start-up stage;
6. Record participators' history of angina pectoris and treatment, or select stable angina from outpatient service (without medicate);
7. Allocate screen number, hand out Guanxi Shutong Capsules Placebo and record card of angina/nitroglycerin used;
8. 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)

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. Withdraw remained drugs and box, and record card;
6. Hand out the drugs for 2 weeks and record card of angina/nitroglycerin used;
7. 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.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. had coronary angiography and verified a least one main branch of coronary stenosis ≥50%;
  2. have typical angina symptom, and also have positive ETT result or CTA shows at least one main branch of coronary stenosis ≥50%;
  3. had history of myocardial infarct (at least 6 months).
* Written informed consent.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Therapeutic effect to Angina ( Average value of angina frequency)
timeFrame: 6 weeks
measure: Exercise treadmill testing (ETT)
timeFrame: 4 weeks
Secondary outcomes:
measure: Usage of nitroglycerine per day (average value)
timeFrame: 4 weeks
measure: Seattle Angina Ques-tionnaire (SAQ)
timeFrame: 4 weeks
measure: Scores on Chinese medical syndrome scale
timeFrame: 4 weeks
measure: Electrocardiogram manifestation
timeFrame: 4 weeks
measure: Time of angina break out from exercise beginning in ETT
timeFrame: 4 weeks
measure: Time of ST below 1 mm from exercise beginning in ETT
timeFrame: 4 weeks
Other outcomes:
measure: Blood fat (TC, TG, HDL-C, LDL-C)
timeFrame: 4 weeks
measure: Degree and duration of angina attack.
timeFrame: 4 weeks
Locations:
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military Region
state: Liaoning
Study officials:
affiliation: Beijing Anzhen Hospital
name: Lv Shuzheng
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Liaoning Hospital of Traditional Chinese Medicine
name: Zhang Yan
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
name: Chen Bojun
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuzhou Central Hospital
name: Luo Wei
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong University of Traditional Chinese Medicine
name: Jiang Binghua
role: PRINCIPAL_INVESTIGATOR
affiliation: Luohe Hospital of Traditional Chinese Medicine
name: Zhang Zhenxian
role: PRINCIPAL_INVESTIGATOR
affiliation: First Hospital of Shijiazhuang City
name: Xing Yanjun
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.