Curative Effect Evaluation of Danlou Tablet on Coronary Artery Disease Not Amenable to Revascularization

Jun Li

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease(CAD)

Treatments: Drug: Trimetazidine Dihydrochloride Tablets; Drug: Metoprolol Tartrate Tab 25 MG; Drug: Aspirin Enteric-coated Tablets; Drug: Atorvastatin calcium; Drug: Danlou Tablet; Drug: Isosorbide Mononitrate Tab 20 MG; Drug: DanLou Tablet placebo; Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03072082

DLT-2016

Details and patient eligibility

About

The purpose of this study is to determine whether Danlou Tablet is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy.

Full description

The western medicine treatment for CAD not amenable to revascularization is limited. Danlou Tablet, a kind of Chinese patent medicine has been used for treating coronary artery disease in clinical practice in China for many years.

Danlou Tablet is applicable to "phlegm-stasis syndrome" in Traditional Chinese Medicine. According to recent studies, Danlou Tablet can reduce blood lipid level and myocardial necrosis area ,promote infarct healing in rats.And it can improve clinical symptoms of patients with CAD.

Enrollment: 440 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants are aged between 45 and 75 years, diagnosed with sever CAD through coronary arteriography which shows that the left main coronary artery and three-vessel have sever diffuse stenosis, calcification or vascular ectasia, be in accordance with Traditional Chinese Medicine syndrome of "Qi deficiency and blood stasis syndrome" or "phlegm and stasis mu-tual obstruction syndrome".

Exclusion criteria

• Patients with severe valvular disease, congenital cardiomyopathy decompensation
• Patients with CAD complicated with severe multiple organ disease such as severe heart failure, severe lung, liver or renal dysfunction, peptic ulcer in active stage, or intracranial hemorrhage
• Patients that use high-dose steroids due to connective tissue disease
• Patients with serious infections
• Patients with malignant tumor
• Patients with hematopoietic diseases
• Pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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440 participants in 2 patient groups, including a placebo group

Danlou Tablet

Experimental group

Description:

Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months \& conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)

Treatment:

Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet

Drug: Danlou Tablet

Drug: Isosorbide Mononitrate Tab 20 MG

Drug: Aspirin Enteric-coated Tablets

Drug: Atorvastatin calcium

Drug: Metoprolol Tartrate Tab 25 MG

Drug: Trimetazidine Dihydrochloride Tablets

Danlou Tablet placebo

Placebo Comparator group

Description:

Placebo Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months \& conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)

Treatment:

Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet

Drug: Isosorbide Mononitrate Tab 20 MG

Drug: DanLou Tablet placebo

Drug: Aspirin Enteric-coated Tablets

Drug: Atorvastatin calcium

Drug: Metoprolol Tartrate Tab 25 MG

Drug: Trimetazidine Dihydrochloride Tablets