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Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)

Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03504202
Acronym
T-MICRO
Enrollment
10
Registered
2018-04-20
Start date
2019-03-01
Completion date
2020-09-01
Last updated
2018-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction

Brief summary

This is a prospective study which aims to explore the effect of Trimetazidine on the improvement of coronary microvascular dysfunction in patients with INOCA (ischemia and no obstructive coronary artery disease). Enrolled patients will be assessed SAQ(Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR(coronary flow reserve) .CFR inspection with D-SPECT and pressure guide wire.Patients will receive six months Trimetazidine(35mg tid) after enrollment. And their SAQ (Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR will be followed up.

Interventions

DRUGTrimetazidine

After enrollment, experimental group will receive Trimetazidine(35mg tid) for six months .

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age≥18 years * Typical angina symptoms * Coronary angiography or coronary computed tomography examination showed no significant epicardial coronary artery stenosis (\<20%) * Never used trimetazidine * The CFR measured by the pressure guide wire is less than 2.0 * agree to participant the study and sign informed written consent * available for six months follow up

Exclusion criteria

* Severe liver and kidney disease * Contraindications of Trimetazidine * Use of CYP3A inhibitors, such as diltiazem, verapamil, and other drugs that may affect CFR measurements * QT interval extension * Atrial fibrillation or left bundle branch block * Left ventricular systolic dysfunction (EF \<55%) * Coronary artery fistula * Myocardial bridge * Non-cardiogenic chest pain and other heart diseases * Severe heart valve disease * Diabetes * Recent ACS( Acute coronary syndrome) * Pregnancy * Failed to complete inspection

Design outcomes

Primary

MeasureTime frame
Coronary flow reserve (CFR) improvessix months

Secondary

MeasureTime frame
Seattle angina score or Canadian angina grade dropssix months
Six-minute walking experiment improvessix months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026