E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To study the effects of higher dose adenosine on intermediate coronary lesions at coronary angiography which require pressure wire study. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to measure the drop in FFR with higher infusion rates (180micrograms/kg/min and 200 micrograms/kg/min) of adenosine |
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E.2.2 | Secondary objectives of the trial |
1. To assess the safety of high dose adenosine as measured by the degree of alteration of heart rate, PR interval, QT interval and arterial blood pressure (SBP, MAP, DBP) in response to each dose. 2. To assess teh degree of patient tolerability of teh two higher doses of adenosine as measured by early discontinuation of drug at patient request. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Any patient listed for pressure wire study of a moderate coronary artery lesion Any patient attending for coronary angiography +/- proceed who is found to have a moderate lesion considered to require pressure wire assessment.
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E.4 | Principal exclusion criteria |
Any patient who is unable or unwilling to give full informed consent. Patients with a contraindication to the administration of adenosine: Patients with a history of allergy or previous adverse reaction to administration of adenosine Second or third degree AV block, sick sinus syndrome (except in patients with a permanent pacemaker) Long QT syndrome Wolff Parkinson White Syndrome Severe hypotension (SBP <90) Unstable angina not successfully stabilised with medical therapy Decompensated heart failure Severe asthma Patients taking dipyridamole Patients taking theophylline / aminophylline therapy
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint point is the difference in FFR with the different doses of adenosine. We aim to recruit 60 patients in order to have an 80%-90% confidence interval to detect a change of 0.03 of FFR. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |