Effects of Xinkeshu Tablets on anxiety and depression, quality of life and recurrent cardiovascular events in patients with acute coronary syndrome with anxiety comorbidity and depressio

Not Applicable

• Conditions: Acute coronary syndrome, anxiety and depression

• Registration Number: ITMCTR2200005750
• Lead Sponsor: Peking University People's Hospital

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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosed inpatients with ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UA) in line with the clinical diagnostic criteria of the International Society of Cardiology, with stable condition before discharge include;
2. In a state of anxiety and comorbid depression: PHQ-9 score = 10 points and GAD-7 score = 10 points;
3. Enrollment age: age > 18 years old, gender is not limited;
4. Subjects gave informed consent and participated voluntarily;

Exclusion Criteria

(1) Taking psychotropic drugs within one week; taking cardiovascular-related Chinese herbal medicines or proprietary Chinese medicines, or Chinese herbal medicines or proprietary Chinese medicines for improving sleep within one week; anti-anxiety and depression drugs and insomnia drugs must be taken;
(2) Pregnant and lactating women;
(3) Severe primary heart, liver, lung, kidney, blood or serious diseases affecting their survival, such as tumor or AIDS; abnormal liver and kidney function, serum ALT and/or AST > 1×ULN (upper limit); , Cr, Urea>1×ULN (upper limit);
(4) Patients with decompensated respiratory insufficiency, myasthenia gravis and sleep apnea syndrome;
(5) Patients with severe epilepsy who cannot give fully informed consent due to mental disorders;
(6) Suspect or have a history of alcohol or drug abuse;
(7) According to the judgment of the investigator, other diseases that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment, are likely to cause loss to follow-up;
(8) Allergic constitution, such as those with a history of allergies to two or more drugs or food; or those who are known to be allergic to the ingredients of this medicine;
(9) Subjects who have participated in or are participating in clinical trials of other drugs within three months before enrollment;
(10) Patients with serious diseases such as malignant tumors, severe chronic obstructive pulmonary disease, and angle-closure glaucoma;
(11) Have a clear history of mental illness (bidirectional disorder, schizophrenia), suicidal tendencies, and language and communication disorders;
(12) limb paralysis due to cerebrovascular sequelae, and other serious diseases are not expected to complete the 1-year follow-up;

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Generalized Anxiexy Disorde-7, GAD-7;Patient Health Questionaire - 9 items,PHQ -9;EuroQol Five Dimensions Questionnaire,EQ-5D;Seattle angina questionnaire,SAQ-7;

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index Questionnaire;Cardiopulmonary exercise test;six-minute walk test;Pittsburgh Sleep Quality Index Questionnaire;medical expenses;Acute myocardial infarction and cardiac readmission rates;