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

P

Peking University

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: nicorandil

Study type

Interventional

Funder types

Other

Identifiers

NCT05087797
M2018253

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

61 participants in 2 patient groups

nicorandil group
Experimental group
Treatment:
Drug: nicorandil
control group
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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