Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina

Angina, Stable Clinical Trial

Official title:

Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina: A Randomised, Double-blind, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02280850
• Other study ID #: YL-CTP-Z20020055
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 23, 2014
• Last updated: October 29, 2014
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2014
• Source: Shaanxi Buchang Pharmaceutical Co., Ltd
• Contact: Han Yaling, Academician
• Phone: +86-24-28856123
• Email: guanxinshutong[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ??? or ?);

• 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 ?-?);

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable

Intervention

Drug:
• Guanxin Shutong Capsule
3 capsules three times a day; Duration: 4 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
• Placebo Capsule
3 capsules three times a day; Duration: 4 weeks.
• nitroglycerine
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.

Locations

Country	Name	City	State
China	The General Hospital of Shenyang Military Region	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shaanxi Buchang Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood fat (TC, TG, HDL-C, LDL-C)		4 weeks	No
Other	Degree and duration of angina attack.		4 weeks	No
Primary	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).	6 weeks	No
Primary	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.	4 weeks	No
Secondary	Usage of nitroglycerine per day (average value)		4 weeks	No
Secondary	Seattle Angina Ques-tionnaire (SAQ)		4 weeks	No
Secondary	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)	4 weeks	No
Secondary	Electrocardiogram manifestation	Compare the changes of electrocardiogram manifestation (such as ST segment, T wave) of angina before and after treatment.	4 weeks	No
Secondary	Time of angina break out from exercise beginning in ETT		4 weeks	No
Secondary	Time of ST below 1 mm from exercise beginning in ETT		4 weeks	No