Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease; Myocardial Ischemia

Treatments: Other: Maximal Hyperemia with Adenosine Followed by Nicorandil; Other: Maximal Hyperemia with Nicorandil Followed by Adenosine

Study type: Interventional

Funder types: Other

Identifiers

NCT01331902

H-1101-069-348

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of maximal coronary hyperemia compared with adenosine.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• non -infarct related, patients with moderate coronary artery stenosis
• normal left ventricular ejection fraction on echocardiogram

Exclusion criteria

• infarct-related arteries or clinically unstable state
• collateral blood flow to the target vessel is shown
• atrioventricular block on electrocardiogram
• reduced left ventricular ejection fraction (<50%) or left ventricular hypertrophy on echocardiogram
• contraindication of adenosine
• bronchial asthma

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Adenosine Followed by Nicorandil

Experimental group

Treatment:

Other: Maximal Hyperemia with Adenosine Followed by Nicorandil

Nicorandil Followed by Adenosine

Experimental group

Treatment:

Other: Maximal Hyperemia with Nicorandil Followed by Adenosine