The patients included in the study were those who (1) presented with stable angina syndromes and were referred for clinically indicated CCTA; and (2) had a heart rate of 70–90 beats/min before undergoing CT screening and immediately before administration of a nitrate vasodilator drug. Patients were excluded from the present study if they had a cardiac
pacemaker or defibrillator or both implanted; had undergone see more coronary-artery bypass surgery; had systolic blood pressure less than 110 mmHg before CCTA; had atrial fibrillation or extrasystoles at imaging; were pregnant, lactating, or possibly pregnant or desiring to become pregnant during the study period; required dialysis treatment; had clinically renal abnormalities defined as serum creatinine >1.5 mg/dL; or the use of β-blockers or non-ionic contrast media was contraindicated. The concomitant use of the following drugs was prohibited: non-dihydropyridine calcium antagonists, antiarrhythmic agents, sympathomimetic
agents, and find more biguanide antidiabetic agents. However, the concomitant use of β-blockers or dihydropyridine calcium antagonists for conditions such as hypertension or angina was allowed. The appropriateness of the study was reviewed and accepted by the Institutional Review Board at each study center before initiating the study. This study was conducted in accordance with the ethical principles LDC000067 nmr in the Declaration of Helsinki, and in compliance with the Pharmaceutical Affairs Law and the Ordinance on Standards for Implementation of Clinical Studies on Drugs (Ministry of Health and Welfare Ordinance No. 28) in Japan. Prior to the study, written informed consent was obtained from all patients upon confirming that they had understood the details of the study. 2.2 Study Design The present study was a multicenter open-label study,
which was conducted at nine study centers in Japan. The eligible subjects received landiolol hydrochloride (0.125 mg/kg) before CCTA. The landiolol hydrochloride dose selection was based on the previous phase II trials in which the efficacy and safety of the drug were examined [9, 10]. In addition, the dose of 0.125 mg/kg Dipeptidyl peptidase was selected in a phase III, double-blind trial . As shown in Fig. 1, the subjects received the study drug as a bolus injection over 1 min after receiving a nitrate drug (nitroglycerin 0.3 mL was administered under the tongue), and underwent CCTA 4–7 min after administration of the study drug. The study period was between August 2009 and February 2010. Fig. 1 Time flow of study drug administration. The study drug was administered over 1 min, 5 or more min after nitrate drug administration. CCTA coronary computed tomography angiography, CT computed tomography 2.3 Endpoints The primary endpoint was the diagnosable proportion (proportion of subjects whose coronary stenosis was diagnosable in reconstructed images).