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A randomized, double-blind, multi-centered, placebo-controlled trial to evaluate efficacy of shexiang baoxin pills in patients with chronic stable coronary artery disease

A randomized, double-blind, multi-centered, placebo-controlled trial to evaluate efficacy of shexiang baoxin pills in patients with chronic stable coronary artery disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12003513
Enrollment
Unknown
Registered
2012-04-18
Start date
2011-07-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic stable coronary artery disease

Interventions

Test group:CAD standard drug treatment with shexiangbaoxin pills, 2 pills each time, 3 times a day, for 2 years
Placebo group:CAD standard drug treatment with placebo, 2 pills each time, 3 times a day, for 2 years

Sponsors

Zhongshan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years at screening; 2. Patients who have ischemia myocardial symptoms and whose clinical symptoms keep stable for at least one month; 3. Have at least one of the following events (providing hospital records or inspection report): 1) history of acute myocardial infarction for at least half of a year; 2) history of PCI or CABG for at least half of a year; 3) coronary CTA angiography or coronary angiography shows that at least one of the main branchs of coronary artery stenosis is no less than 50%. 4. Provide informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of acute myocardial infarction, vascular reconstruction, CABG or PCI within half of a year; 2. Prepared to undertake CABG or PCI during this study; 3. Serious cardiovascular diseases: sustained severe angina (CCS ?), refractory heart failure, cardiogenic shock, severe aortic stenosis or aortic insufficiency; 4. Severe respiratory diseases; 5. Diabetic patients with poor glycemic control (fasting blood glucose > 200 mg/dl or 11.1mmol/L for more than twice within one month before the study entry); 6. Hypertensive patients with poor control of blood pressure, SBP >=180mmHg or DBP>=110mmHg before entry; 7. Severe liver and kidney diseases,such as active liver disease, cirrhosis and uremia; 8. Any other severe diseases, such as malignant tumor, severe anemia and severe renal artery stenosis; 9. Unable or unwilling to sign informed consent form; 10. Join another trial or has received random allocation of this study within one month before entry; 11. Pregnant or who were attempting to become pregnant; 12. Patients who are regarded as not being suitable participants by the study investigators.

Design outcomes

Primary

MeasureTime frame
Cardiovascular death;Nonfatal myocardial infarction;Nonfatal strok;

Secondary

MeasureTime frame
All cause death;Coronary angioplasty;Due to unstable angina or heart failure hospitalization;

Contacts

Public ContactGe Junbo
ge.junbo@zs—hospital.sh.cn+86 13901977506

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026