Metabolic disease
Conditions
Interventions
basic treatment + FTZ group:basic treatment + FTZ
basic treatment + FTZ placebo group:basic treatment + FTZ placebo
Sponsors
The first affiliated hospital/school of clinical medicine of Guangdong pharmaceutical university
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. According to the diagnostic criteria for diabetes and coronary heart disease simultaneously in Western Medicine; 2. Aged 18-80 years old male and female; 3. Informed consents will be signed voluntarily and all the subjects agree to participate in all the interviews, examinations and treatments according to the requirements of the test plan.
Exclusion criteria
Exclusion criteria: 1. Type I diabetes mellitus or secondary diabetes mellitus; 2. Patients with unstable condition, such as ACS, acute left heart failure and acute complications of diabetes mellitus within three months; 3. Patients who plan for cardiac intervention or surgery in 1 year; 4. Pregnant or lactating women; 5. The life expectancy of patients with diabetic coronary heart disease associated with malignant tumor is less than 2 years; 6. Patients known or suspected of being sensitive to the study drug; 7. Severe renal impairment (eGFR=30%) and severe pulmonary disease (acute and chronic respiratory failure and moderate and severe pulmonary fibrosis, lung damage); ALT increased abnormally and CK increased abnormally (more than 2 times the upper limit of normal reference values); 8. Patients with mental disease and other patients who cannot cooperate with the drug use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and mortality rate of cardiovascular events (acute coronary syndrome, non-planned vascular remodeling, acute left heart failure, stroke etc.) in patients with diabetic coronary heart disease treated with FTZ capsule.;Indexes of blood lipid, blood glucose, endothelial function, microvascular, atherosclerosis and overall status (health status questionnaire SF-36, TCM symptom score, etc.) of patients with diabetic coronary heart disease treated with FTZ capsule.; Indexes of type, dosage, adverse reactions, etc. of drugs combined with FTZ to treat patients with diabetic coronary heart disease.; | — |
Countries
China
Contacts
Public ContactGuo Jiao
Guangdong Pharmaceutical University
Outcome results
None listed