Effect of Trimetazidine on the Improvement of Coronary Mi... | NCT03504202

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

NCT03504202

Sponsor

Shanghai 10th People's Hospital

Status

Unknown status

Last Update Posted

Oct 25, 2018Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

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

Interventions

Trimetazidine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Estimated

Primary Completion Date

Apr 1, 2020Estimated

Completion Date

Sep 1, 2020Estimated

First Submitted Date

Apr 11, 2018

First Submission Date that Met QC Criteria

Apr 19, 2018

First Posted Date

Apr 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2018

Last Update Posted Date

Oct 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trimetazidine	Experimental		Drug: Trimetazidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trimetazidine	Drug	After enrollment, experimental group will receive Trimetazidine(35mg tid) for six months .	Trimetazidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coronary flow reserve (CFR) improves		six months

Secondary Outcomes

Measure	Description	Time Frame
Seattle angina score or Canadian angina grade drops		six months
Six-minute walking experiment improves		six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds