Qishenyiqi Dripping Pill for Coronary Microvascular Disease
ConditionCoronary Microvascular Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-75
SponsorQilu Hospital of Shandong University
About this trial
To investigate the efficacy and safety of Qishenyiqi in patients with microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Qishenyiqi on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
Coronary normal or stenosis < 20%;
Ischemic depression in ST segment during resting or exercise;
Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;
Disqualifiers
Previous myocardial infarction or PCI or CABG treatment;
A history of heart failure;
Severe arrhythmia;
Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm;
Trial design
Design model
Parallel
Treatments tested in this trial
Qishenyiqi dripping pills 1 bag, three times a day
DrugQishenyiqi dripping pills, 1 bag once, three times a day, 12 months
Placebo 1 bag, three times a day
DrugPlacebo, 1 bag once, three times a day, 12 months
Treatment groups
162 Participants
are divided into 2 treatment groupsGroup A: Qishenyiqi Dripping PillExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov