A prospective, multi-center, double-blind, randomized, placebo-controlled trial is conducted to evaluate the efficacy and safety of Yinxingmihuan oral solution in the treatment of chest pain after percutaneous coronary intervention (PCI) in patients with stable angina. Patients should undergo at least 1-week standardized medical treatment phase before randomization. The primary end point is the 12-week angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ) subscales. The main secondary endpoint is the improvement of anxiety assessed by Hamilton Anxiety Scale (HAMA) to evaluate its effectiveness for chest pain caused by psychological factors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
320
Yinxingmihuan oral solution is made of Ginkgo leaf extract and armillariella mellea powders.
The placebo oral solution is in the same appearance, color, smell and taste as the experimental Yinxingmihuan oral solution.
Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences
Beijing, China
SAQ-angina frequency
angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ-AF)
Time frame: at 12-week follow-up
HAMA improvement
variation of the value of Hamilton Anxiety Scale (HAMA) at 12-week follow-up compared with baseline
Time frame: at 12-week follow-up
CCS grade
angina grade assessed by Canadian Cardiovascular Society (CCS)
Time frame: before randomization, in 4,8,12,16 and 20 weeks
NYHA class
heart function assessed by New York Heart Association (NYHA)
Time frame: before randomization, in 4,8,12,16 and 20 weeks
VAS
generic health status assessed by visual analogue scale (VAS)
Time frame: before randomization, in 4,8,12,16 and 20 weeks
HAMA reductive ratio
variation of Hamilton Anxiety Scale (HAMA) score at 12-week follow-up compared with baseline divided by the baseline value
Time frame: at 12-week follow-up
HAMD depression score
proportion of participants with improvement or disappear of depression according to Hamilton Depression Scale (HAMD)
Time frame: before randomization, in 4,8,12,16 and 20 weeks
weekly angina frequency
weekly angina frequency recorded by the participants' diary cards
Time frame: before randomization, in 4,8,12,16 and 20 weeks
SF-12 score
generic health status measured by 12-Item Short Form Health Survey (SF-12)
Time frame: before randomization, in 4,8,12,16 and 20 weeks
Nitroglycerin discontinuation rate
proportion of participants that no longer need any nitroglycerin medications
Time frame: before randomization, in 4,8,12,16 and 20 weeks
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