Clinical trial NCT03072082: Curative Effect Evaluation of Danlou Tablet on Coronary Artery Disease Not Amenable to Revascularization
Official title: Study of Curative Effect Evaluation of DanLou Tablet on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease(CAD)
Keywords: coronary artery disease
revascularization
Danlou Tablet
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: China Academy of Chinese Medical Sciences
First posted: 2017-03-07
Enrollment: 440
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: Six months after randomisation
Secondary outcomes:
measure: Ejection fraction percentage (EF%)
timeFrame: At baseline (before randomisation), and six months after randomisation
measure: E/A ratio
timeFrame: At baseline (before randomisation), and six months after randomisation
measure: C-reactive protein (CRP)
timeFrame: At baseline (before randomisation), and six months after randomisation.
measure: B-type natriuretic peptide (BNP)
timeFrame: At baseline (before randomisation), and six months after randomisation.
measure: Hospital readmission rates
timeFrame: At baseline (before randomisation), and six months after randomisation.
Other outcomes:
Locations:
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jie Wang, MD
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.