E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The trial is to investigate whether applying a transdermal GTN patch over the radial artery reduces spasm of the artery during coronary angiography. This is a pilot 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 determine whether transdermal GTN reduces the incidence of arterial spasm during coronary angiography. This is a pilot study to inform a possible furture RCT (which will be submitted to ethics, MHRA and R&D at a later date). |
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E.2.2 | Secondary objectives of the trial |
Whether the patch also eases cannulation, reduces procedure time and increases artery diameter on ultrasound. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult patients referred for non-emergency coronary angiography, who are to be treated by one of two consultants who use the radial artery as the access site, (rather than the femoral artery). Patent Radial and Ulnar artery as determined by an Allen’s test |
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E.4 | Principal exclusion criteria |
Those who are not able to attend for ultrasound scans Those not suitable for transradial coronary angiography. Patients without clinical evidence of a patent Ulnar Artery on Allen’s test. Those with a clincically small Radial Artery. Any of the following contra-indications to GTN. Contra-indicated in patients hypersensitive to nitrates and in patients with marked anaemia. Extensive co-mobidites or pregnancy. Unable to given informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Spasm will be the primary outcome as this is the most common complication and will be classified into three groups; mild, moderate and severe. Spasm will be recorded and subjectively measured by the cardiologist; this is the way spasm has been recorded in the literature. Mild spasm is when the patient reports pain or discomfort but no treatment is needed, moderate spasm is when a cocktail of drugs to relieve the spasm are needed to continue with the procedure and severe spasm is when despite the cocktail of drugs being given, the procedure has to be abandoned. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | No |
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
| |
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 | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |