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NCT Number: NCT06699420

Qishenyiqi Dripping Pill for Coronary Microvascular Disease

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.

Recruiting

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Key information

Conditions

Coronary Microvascular Disease Angina Pectoris Cardiovascular Diseases Heart Diseases Microvascular Angina Myocardial Ischemia Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jinan Central Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Subjects or their guardians agreed to participate in this study.

Exclusion criteria

  • 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;
  • Familial hypercholesterolemia;
  • Takayasu arteritis, Kawasaki disease or coronary artery malformation;
  • Pregnant or nursing, or having the intention to give birth within one year;
  • Hepatic or renal dysfunction;
  • Allergic to contrast agents or traditional Chinese medicines;
  • Patients who participated in clinical research of other drugs within 3 months before being selected.

Treatment and study plan

Qishenyiqi dripping pills 1 bag, three times a day

Drug

Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months

Placebo 1 bag, three times a day

Drug

Placebo, 1 bag once, three times a day, 12 months

Primary outcomes

  1. Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Panpan Hao, Dr.

CONTACT

[email protected]

8618560086593

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

The Efficacy and Safety of Qishenyiqi Dripping Pill in Patients With Coronary Microvascular Disease

Acronym: CMVD

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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