A randomized, double-blind, placebo-controlled, multi-center clinical study of Suxiao Jiuxin pills in patients with coronary heart disease nitrate intolerance

Phase 4

Recruiting

• Conditions: coronary artery disease

• Registration Number: ITMCTR2100005180
• Lead Sponsor: The Affiliated Hospital of Shandong University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria for chronic stable angina pectoris.
2. CCS angina pectoris grades I to III.
3. Aged 30 to 70 years.
4. Those who are intolerant to nitrates.
5. The subjects voluntarily signed the informed consent.

Exclusion Criteria

1. Patients with acute myocardial infarction, unstable angina pectoris, stable angina pectoris with exertion IV and other heart diseases;
2. Combined with poorly controlled hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), use of pacemaker and history of cerebrovascular disease within 1 year ;
3. History or evidence of any of the following diseases during the screening period: severe cardiovascular and cerebrovascular diseases; active, recurrent digestive system ulcers or other diseases with bleeding risk; other serious diseases of the digestive system; combined with malignant tumors, hematological diseases or other serious or progressive diseases; combined with other mental diseases and unable to cooperate or unwilling to cooperate;
4. Any one of the laboratory test indicators before screening meets the following criteria: admission liver and kidney function prompts: ALT, AST > 1.5 times the upper limit of normal value, Cr > 1.2 times the upper limit of normal value (Refer to the normal range of laboratory tests in the research center); other clinically significant laboratory tests are abnormal, and the investigators judge that they are not suitable for inclusion;
5. Suspect or have a history of alcohol or drug abuse;
6. Pregnant, lactating patients or those who are planning to become pregnant in the near future and who are unwilling to use contraceptive measures;
7. Patients who have participated in clinical trials of other drugs within 3 months before enrollment;
8. The researchers believe that patients should not participate in this clinical trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of main symptoms of TCM;Seattle angina questionnaire;Electrocardiogram;Patient-reported clinical outcome scale for coronary heart disease and angina pectoris;Blood stasis syndrome score;