A Phase 4 interventional study of Compound Danshen Dripping Pills and Placebo in Coronary Microvascular Disease, sponsored by Qilu Hospital of Shandong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Qilu Hospital of Shandong University · Phase 4, Interventional, and Treatment
Objective: To investigate the effect of Compound Danshen Dripping Pills （CDDP）on improving coronary flow reserve（CFR） in patients with coronary microvascular disease (CMVD) and to evaluate their efficacy and safety.
Study Design: Randomized, double-blind, placebo-controlled, multicenter clinical trial.
Study population: Patients with ischemia-related CMVD and myocardial infarction-related CMVD.
Intervention：Treatment group：standard therapy plus CDDP, Twenty pills (27 mg each) orally, three times daily after meals.Control group：standard therapy plus matching placebo, Twenty pills (27 mg each) orally, three times daily after meals.Treatment duration 12 months.
Primary Endpoint: Change in CFRmax from baseline to Month 12 (ΔCFRmax-12m) by Transthoracic Doppler echocardiography(TTE).
Rationale for the Study：Coronary Microvascular Disease (CMVD) is a clinical syndrome manifested as effort-induced angina pectoris or laboratory evidence of myocardial ischemia, which results from structural and/or functional abnormalities of the coronary pre-arterioles and arterioles under the effects of multiple pathogenic factors. Impaired coronary microcirculatory function is closely associated with long-term clinical outcomes in patients. A reduced coronary flow reserve (CFR) is not only associated with persistent angina, decreased exercise tolerance, and impaired quality of life, but also independently predicts the risk of cardiovascular death, non-fatal myocardial infarction, heart failure hospitalization, and major adverse cardiovascular events (MACE).Current domestic and international guidelines recommend risk factor control and anti-ischemic therapy as the foundational treatment for CMVD. However, the pathogenesis of CMVD is complex, involving multiple pathological processes such as endothelial dysfunction, microvascular spasm, microvascular remodeling, and inflammation. There is considerable heterogeneity in the treatment benefits among different patients, and evidence-based therapeutic strategies that can definitively improve coronary microcirculatory function and delay disease progression are still lacking.
Basic and clinical studies have demonstrated that the Chinese medicinal compound Compound Danshen Dripping Pills (CDDP) can improve vascular endothelial function and relieve angina pectoris, and it has been widely applied in clinical practice. In the preliminary study entitled Clinical Study on the Effect of Compound Danshen Dripping Pills on Coronary Flow Reserve in Patients with Coronary Microvascular Angina, CDDP effectively improved coronary flow reserve in patients with CMVD. These findings support the value of conducting larger-scale clinical studies to explore its clinical efficacy for CMVD, symptom improvement, and effects measured by the Seattle Angina Questionnaire.
Objective: To investigate the effect of Compound Danshen Dripping Pills （CDDP）on improving coronary flow reserve（CFR） in patients with coronary microvascular disease (CMVD) and to evaluate their efficacy and safety.
Hypothesis: In patients with CMVD receiving standard anti-ischemic therapy, treatment with CDDP for 12 months will significantly improve CFR, reduce major adverse cardiovascular events（MACE）, and improve quality of life compared with placebo.
This study adopts a stratified-block randomization design. A total of 496 study participants were divided into two subgroups according to disease diagnosis (Subgroup A: Ischemia-related CMVD; Subgroup B: Myocardial infarction-related CMVD, 248 participants in each subgroup). After the classification of participants into disease-specific subgroups, the system automatically activated the block allocation module corresponding to each subgroup. Participants were assigned to pre-defined groups sequentially according to the real-time enrollment order until the full quota of the subgroup was fulfilled.
During the study, a total of 5 visits will be conducted (Baseline/Screening, Month 3, Month 6, Month 9, and Month 12). At each visit, clinical data will be collected, along with an electrocardiogram (ECG), Canadian Cardiovascular Society (CCS) angina grading, and Seattle Angina Questionnaire (SAQ) scoring. Laboratory tests and echocardiography (including CFR assessment) will be performed at Baseline/Screening, Month 6, and Month 12.
Blood Sampling Protocol: Fasting venous blood samples will be collected at the clinical laboratory of Qilu Hospital of Shandong University on the mornings of the Baseline, Month 6, and Month 12 visits. A total of 3 samples will be collected, with 10 mL drawn each time (total volume: 30 mL). All samples will be sent to the clinical laboratory of Qilu Hospital of Shandong University.
Laboratory Assessments: The blood samples will first be used for routine clinical laboratory tests, including complete blood count (CBC), urinalysis, liver function (ALT, AST), renal function (serum creatinine, urea/BUN), coagulation panel (PT, APTT, TT, FIB), lipid profile (TC, TG, LDL-C, HDL-C), and myocardial enzymes (troponin T [TnT], creatine kinase [CK]). The remaining samples will be utilized for exploratory assessments, such as the detection of inflammatory and endothelial biomarkers, as well as omics screening. Any residual blood samples after the aforementioned tests will be stored uniformly in the cardiovascular laboratory for further exploratory testing in the future.
This study is a large-sample RCT clinical trial targeting CMVD, and is expected to provide evidence-based medical evidence for the treatment of CMVD.
126 studies on the registry are indexed under Microvascular Angina; 37 are open to participants now.
This study's planned enrollment of 496 is above the median of 70 across 80 interventional studies indexed under Microvascular Angina.
Browse Microvascular Angina studies →Qilu Hospital of Shandong University is the lead sponsor of 305 studies on the registry; 184 are open to participants now.
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（1）Ischemia-related CMVD:
Myocardial Ischemia with Non-Obstructive Coronary Arteries: Presence of symptoms consistent with chronic myocardial ischemia, together with objective evidence of reduced CFR and/or coronary microvascular spasm, in the absence of obstructive epicardial coronary artery disease.
②Myocardial Ischemia with obstructive Coronary Arteries: Following successful treatment of epicardial coronary artery stenosis with residual luminal stenosis ≤50%, TTE demonstrates persistent impairment of CFR \<2.5 in the LAD.
（2）Myocardial infarction-related CMVD:
Myocardial infarction with non-obstructive coronary arteries (MINOCA): Coronary CTA or invasive coronary angiography demonstrates coronary artery stenosis ≤50%.
Myocardial infarction with obstructive coronary arteries (MIOCA): Typically associated with coronary microvascular obstruction, including but not limited to ST-segment elevation myocardial infarction (STEMI) complicated by coronary microvascular obstruction.
5.Voluntary provision of written informed consent by the subject or legal representative.
Exclusion Criteria:
Participants receive conventional treatment plus Compound Danshen Dripping Pills (CDDP), 20 pills (540 mg) orally three times daily for 12 months.
Drug: Compound Danshen Dripping Pills
Participants receive conventional treatment plus placebo pills matching CDDP in appearance, 20 pills orally three times daily for 12 months.
Drug: Placebo
20 pills (540 mg) orally three times daily for 12 months. Each pill weighs 27 mg, containing Radix Salviae miltiorrhizae, Radix Notoginseng, and Borneolum Syntheticum. Manufactured and supplied by Tasly Pharmaceutical Group Co., Ltd.
Also known as: CDDP, Fufang Danshen Diwan, Cardiotonic Pill, Dantonic Pill, T89
Placebo pills identical to Compound Danshen Dripping Pills in appearance, taste, and packaging, 20 pills orally three times daily for 12 months.
Also known as: Matching placebo
Change from baseline in peak coronary flow reserve (CFRmax) of the left anterior descending artery
CFRmax is defined as the ratio of hyperemic to basal peak diastolic flow velocity (PDV) in the mid-to-distal left anterior descending artery, measured by transthoracic Doppler echocardiography (TTDE) during regadenoson-induced maximal hyperemia (regadenoson 0.4 mg/5 mL administered as a single intravenous bolus over approximately 10 seconds, followed by a saline flush). Measurements are performed at baseline, 6 months, and 12 months. Change from baseline at each time point is calculated as the value at that time point minus the baseline value. The primary analysis time point is 12 months.
Time frame: Baseline, 6 months, and 12 months
Change from baseline in mean coronary flow reserve (CFRmean) of the left anterior descending artery
CFRmean is defined as the ratio of hyperemic to basal mean diastolic flow velocity (MDV) in the mid-to-distal left anterior descending artery, measured by transthoracic Doppler echocardiography (TTDE) during regadenoson-induced maximal hyperemia (regadenoson 0.4 mg/5 mL administered as a single intravenous bolus over approximately 10 seconds, followed by a saline flush). Measurements are performed at baseline, 6 months, and 12 months. Change from baseline at each time point is calculated as the value at that time point minus the baseline value.
Time frame: Baseline, 6 months, and 12 months
Change from baseline in Seattle Angina Questionnaire (SAQ) score
The Seattle Angina Questionnaire (SAQ) is a disease-specific health status measure for coronary artery disease. Each of its five domains (Physical Limitation, Anginal Stability, Anginal Frequency, Treatment Satisfaction, and Disease Perception/Quality of Life) is scored from 0 to 100, with higher scores indicating better health status (fewer symptoms/limitations). Change from baseline is calculated as the score at each time point minus the baseline score.
Time frame: Baseline, 3, 6, 9, and 12 months
Change from baseline in CCS angina class
Angina severity is classified by the Canadian Cardiovascular Society (CCS) angina classification, ranging from Class I (angina only during strenuous exertion; least severe) to Class IV (angina at rest; most severe), where a higher class indicates a worse outcome. Improvement is defined as a reduction of ≥1 CCS class grade from baseline at each assessment time point.
Time frame: Baseline, 3, 6, 9, and 12 months
Incidence of major adverse cardiovascular events (MACE) within 12 months
MACE is a composite endpoint defined as the occurrence of any of the following components during the 12-month follow-up period: (1) cardiovascular death; (2) non-fatal myocardial infarction; (3) hospitalization for angina pectoris; and (4) hospitalization for heart failure.
Time frame: From randomization/enrollment through 12 months
Plan to share: No — Individual participant data will not be shared. The informed consent form approved by the ethics committee and signed by participants did not include provisions for sharing de-identified individual participant data beyond the research team or with external investigators, and additional consent for data sharing was not obtained at the time of enrollment.
Start is estimated for Oct 2026; primary completion for Nov 2028, 25 months later.
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