- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03072082
Curative Effect Evaluation of Danlou Tablet on Coronary Artery Disease Not Amenable to Revascularization
Study of Curative Effect Evaluation of DanLou Tablet on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Danlou Tablet
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)
|
20 mg tablet, one tablet three times daily.
Other Names:
Conventional western medicine & Danlou Tablet
100 mg tablet, one tablet daily.
One tablet daily.
(for patients who can't use aspirin)
Other Names:
10 mg tablet, two tablets each night.
Other Names:
One tablet two times daily.
Other Names:
12.5 mg or 25 mg two times daily.
Other Names:
|
Placebo Comparator: Danlou Tablet placebo
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)
|
20 mg tablet, one tablet three times daily.
Other Names:
100 mg tablet, one tablet daily.
One tablet daily.
(for patients who can't use aspirin)
Other Names:
10 mg tablet, two tablets each night.
Other Names:
One tablet two times daily.
Other Names:
12.5 mg or 25 mg two times daily.
Other Names:
Conventional western medicine & placebo (for Danlou Tablet)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: Six months after randomisation
|
Death caused by cardiovascular disease
|
Six months after randomisation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ejection fraction percentage (EF%)
Time Frame: At baseline (before randomisation), and six months after randomisation
|
One of Echocardiographic parameters
|
At baseline (before randomisation), and six months after randomisation
|
E/A ratio
Time Frame: At baseline (before randomisation), and six months after randomisation
|
One of Echocardiographic parameters
|
At baseline (before randomisation), and six months after randomisation
|
C-reactive protein (CRP)
Time Frame: At baseline (before randomisation), and six months after randomisation.
|
CRP in μg/L
|
At baseline (before randomisation), and six months after randomisation.
|
B-type natriuretic peptide (BNP)
Time Frame: At baseline (before randomisation), and six months after randomisation.
|
BNP in pg/mL
|
At baseline (before randomisation), and six months after randomisation.
|
Hospital readmission rates
Time Frame: At baseline (before randomisation), and six months after randomisation.
|
Hospital readmission rates due to coronary artery disease during treatment
|
At baseline (before randomisation), and six months after randomisation.
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Zhao D. [Why dentists need to learn the epidemiological status and prevention strategy of coronary heart disease in China]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2016 Jul;51(7):385-6. doi: 10.3760/cma.j.issn.1002-0098.2016.07.001. Chinese.
- Zhu H, Luo XP, Wang LJ. [Evaluation on clinical effect of long-term shexiang baoxin pill administration for treatment of coronary heart disease]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2010 May;30(5):474-7. Chinese.
- Zhou Z, Shen W, Yu L, Xu C, Wu Q. A Chinese patent medicine, Shexiang Baoxin Pill, for Non-ST-elevation acute coronary syndromes: A systematic review. J Ethnopharmacol. 2016 Dec 24;194:1130-1139. doi: 10.1016/j.jep.2016.11.024. Epub 2016 Nov 12.
- Williams B, Menon M, Satran D, Hayward D, Hodges JS, Burke MN, Johnson RK, Poulose AK, Traverse JH, Henry TD. Patients with coronary artery disease not amenable to traditional revascularization: prevalence and 3-year mortality. Catheter Cardiovasc Interv. 2010 May 1;75(6):886-91. doi: 10.1002/ccd.22431.
- Gupta S, Pressman GS, Morris DL, Figueredo VM. Distribution of left ventricular ejection fraction in angina patients with severe coronary artery disease not amenable to revascularization. Coron Artery Dis. 2010 Aug;21(5):278-80. doi: 10.1097/MCA.0b013e32833bdf53.
- Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
- Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.
- Wang L, Mao S, Qi JY, Ren Y, Guo XF, Chen KJ, Zhang MZ. Effect of Danlou Tablet () on peri-procedural myocardial injury among patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndrome: A study protocol of a multicenter, randomized, controlled trial. Chin J Integr Med. 2015 Sep;21(9):662-6. doi: 10.1007/s11655-015-2284-1. Epub 2015 Jul 4.
- Wang SH, Wang J, Li J. [Efficacy assessment of treating patients with coronary heart disease angina of phlegm and stasis mutual obstruction syndrome by Danlou tablet]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2012 Aug;32(8):1051-5. Chinese.
- Chen J, Cai HW, Miao J, Xu XM, Mao W. [Danlou Tablet Fought against Inflammatory Reaction in Atherosclerosis Rats with Intermingled Phlegm and Blood Stasis Syndrome and Its Mechanism Study]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2016 Jun;36(6):703-8. Chinese.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Antimetabolites
- Natriuretic Agents
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Diuretics, Osmotic
- Diuretics
- Calcium-Regulating Hormones and Agents
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Nitric Oxide Donors
- Aspirin
- Atorvastatin
- Clopidogrel
- Calcium
- Metoprolol
- Isosorbide
- Isosorbide Dinitrate
- Isosorbide-5-mononitrate
- Trimetazidine
Other Study ID Numbers
- DLT-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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