Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences
Beijing, 100037, China
NCT Number: NCT06224582
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.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Beijing, 100037, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Yinxingmihuan oral solution is made of Ginkgo leaf extract and armillariella mellea powders.
Other names: 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.
Time frame: at 12-week follow-up
angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ-AF)
Time frame: at 12-week follow-up
variation of the value of Hamilton Anxiety Scale (HAMA) at 12-week follow-up compared with baseline
Time frame: before randomization, in 4,8,12,16 and 20 weeks
angina grade assessed by Canadian Cardiovascular Society (CCS)
Time frame: before randomization, in 4,8,12,16 and 20 weeks
heart function assessed by New York Heart Association (NYHA)
Time frame: before randomization, in 4,8,12,16 and 20 weeks
generic health status assessed by visual analogue scale (VAS)
Time frame: at 12-week follow-up
variation of Hamilton Anxiety Scale (HAMA) score at 12-week follow-up compared with baseline divided by the baseline value
Time frame: before randomization, in 4,8,12,16 and 20 weeks
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 recorded by the participants' diary cards
Time frame: before randomization, in 4,8,12,16 and 20 weeks
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
proportion of participants that no longer need any nitroglycerin medications
Time frame: before randomization, in 4,8,12,16 and 20 weeks
Physical limitation assessed on the basis of Seattle Angina Questionnaire
Time frame: before randomization, in 4,8,12,16 and 20 weeks
Anginal stability assessed on the basis of Seattle Angina Questionnaire
Time frame: before randomization, in 4,8,12,16 and 20 weeks
Treatment satisfaction assessed on the basis of Seattle Angina Questionnaire
Time frame: before randomization, in 4,8,12,16 and 20 weeks
Disease perception assessed on the basis of Seattle Angina Questionnaire
China National Center for Cardiovascular Diseases
Other Gov
Efficacy and Safety of Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI: A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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