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The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion

The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05087797
Enrollment
61
Registered
2021-10-21
Start date
2019-04-08
Completion date
2020-07-08
Last updated
2021-10-21

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

Conditions

Coronary Artery Disease

Brief summary

Background Nicorandil is recommended as a second-line treatment for stable angina, but randomized-controlled trials (RCTs) to evaluate the benefit of nicorandil for patients with chronic total occlusion (CTO) are still lack. Objective To determine whether nicorandil can improve left ventricular myocardial strain in patients with CTO. Methods Patients with CTO were included and were randomized to the nicorandil group and the control group. Nicorandil was given orally 15 mg/day for 3 months in the nicorandil group. 3-dimentional-speckle tracking echocardiography (3D-STE) and the Seattle angina questionnaire (SAQ) survey were performed at baseline and at 3 months. Participants were randomized according to an IBM SPSS23.0-generated randomization schedule, with a 1:1 allocation to the nicorandil group or the control group.

Interventions

DRUGnicorandil

Patients in the nicorandil group were also given nicorandil (Tohoku Nipro Pharmaceutical Corporation, Japan) orally 5 mg three times per day for 3 months

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* age between 18 and 80 years;1 or more CTO vessels (≥2mm in diameter)

Exclusion criteria

* successful PCI for all CTO lesions; ST segment elevation myocardial infarction (STEMI) during the past 3 months; planed coronary artery bypass grafting (CABG) within 3 months; valvular heart disease or congenital heart disease; cardiomyopathy; heart failure with NYHA (New York Heart Association) class III or above; persistent atrial fibrillation or complete left bundle branch block; severe liver, kidney, or lung diseases

Design outcomes

Primary

MeasureTime frame
total area strain3 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026