CClinicalTrials.gg
Status unknownNCT04220372Updated Jan 7, 2020

Tongxinluo Capsule for Coronary Microvascular Disease

A Phase 4 interventional study of Tongxinluo and Placebo in Coronary Microvascular Disease, sponsored by Qilu Hospital of Shandong University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-07.

Sponsored by Qilu Hospital of Shandong University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To investigate the efficacy and safety of Tongxinluo in patients with microvascular angina pectoris. Long-term follow-up of 1 to 5 years will be performed to evaluate the effect of Tongxinluo on long-term adverse cardiovascular events in patients with coronary microvascular disease.

02

Conditions studied

  • Coronary Microvascular Disease

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03

In context

Microvascular Angina

123 studies on the registry are indexed under Microvascular Angina; 36 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 77 interventional studies indexed under Microvascular Angina.

Browse Microvascular Angina studies →

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
  2. Coronary normal or stenosis \< 20%;
  3. Ischemic depression in ST segment during resting or exercise;
  4. Blood flow reserve (CFR) of the anterior descending coronary artery \< 2.0;
  5. Subjects or their guardians agreed to participate in this study.

Exclusion criteria

Exclusion Criteria:

  1. Previous myocardial infarction or PCI or CABG treatment;
  2. A history of heart failure or LVEF \< 50%;
  3. Severe arrhythmia;
  4. Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
  5. A history of stroke within half a year;
  6. Diabetes difficult to control;
  7. Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm;
  8. Familial hypercholesterolemia;
  9. Takayasu arteritis, Kawasaki disease or coronary artery malformation;
  10. Pregnant or nursing, or having the intention to give birth within one year;
  11. Hepatic or renal dysfunction;
  12. Other diseases which may cause serious risks to patients;
  13. Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;
  14. Allergic to contrast agents or blood products;
  15. Patients who participated in clinical research of other drugs within 3 months before being selected.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Tongxinluo Capsule

    Drug: Tongxinluo

  • Placebo comparator
    Placebo Capsule

    Drug: Placebo

Interventions

  • DrugTongxinluo

    Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD

  • DrugPlacebo

    Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD

06

What researchers measure

Primary outcomes

  1. Changes of Coronary Flow Reserve

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04220372
Lead sponsor
Qilu Hospital of Shandong University
Responsible party
Pan-Pan Hao (MD, Qilu Hospital of Shandong University) — Principal investigator
First posted
Jan 7, 2020
Start date
Jan 2020 (estimated)
Primary completion
Jan 2021 (estimated)
Completion
Jan 2025 (estimated)
Last update
Jan 7, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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