E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Investigation of otherwise healthy women with chest pain without significant stenoses in their epicardial coronary arteries. |
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E.1.1.1 | Medical condition in easily understood language |
Investigation of chest pain in women with normal or near normal coronary arteries. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
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 women with chest pain with no or minimal angiographic coronary artery disease, have a raised index of microvascular resistance.
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E.2.2 | Secondary objectives of the trial |
1. To determine whether high-dose statin treatment will modify the index of microvascular resistance in women with chest pain without significant coronary disease.
2. To determine the relationship between IMR and • Inflammation • Endothelial function • Large vessel compliance
3. To investigate the effect of a statin on • Inflammatory variables • Quality of life • Chest pain |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Female gender 2. Age 30 - 60 years 3. Chest pain suggestive of symptomatic coronary artery disease 4. A coronary angiogram with no or minimal coronary artery disease 5. FFR value over 0,80
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E.4 | Principal exclusion criteria |
1. Male gender 2. Age under 30 years or over 60 3. Coronary artery stenosis ≥ 33 % in any epicardial vessel 4. FFR value ≤ 0,80 5. Short life expectancy 6. Uncontrolled endocrinological disease 7. Arterial hypertension 8. Structural heart disease 9. Significant mental disorder, including dementia 10. Inability to comply with the protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is change in index of microvascular resistance. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Angina functional class. Quality of life. Tonometry. Laboratory parameters of inflammation |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.3 | Therapy | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |