E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Myocardial Ischemia |
Myokardischämie |
|
E.1.1.1 | Medical condition in easily understood language |
Bad blood circulation in the heart muscle |
Schlechte Durchblutung des Herzmuskels |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028601 |
E.1.2 | Term | Myocardial ischemia |
E.1.2 | System Organ Class | 100000004849 |
|
E.1.3 | Condition being studied is a rare disease | Information not present in EudraCT |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate if platelet inhibition with Aspirin 100 mg (Acetylsalicylic acid / ASA) and/or lowering of LDL-cholesterol with Atorvastatin 20 mg (Statin) is superior to placebo in reduction of death, myocardial infarction (MI) and coronary revascularization in patients with symptoms suggestive for Acute Coronary Syndrome (ACS) and elevated high-sensitivity troponin (hsTn) values, not classified as having ACS |
Evaluation der Sicherheit und Wirksamkeit der i.v. Gabe von Aspirin (Acetylsalicylsäure / ASS) 100 mg und/oder Atorvastatin (Statin) 20 mg im Vergleich zu Placebo bei Patienten mit erhöhtem Troponin und Symptomen die suggestiv für ein akutes Koronarsyndrom sind. Der Nachweis erfolgt mittels des folgenden Endpunktes: Primärer Wirksamkeitsendpunkt: Zeit bis zum Myokardinfarkt (AMI), bis zur Koronarrevaskularisation, oder Tod - was zuerst eintritt |
|
E.2.2 | Secondary objectives of the trial |
The secondary efficacy objectives are to compare the active treatment and placebo groups with respect to: 1.) The risk of the composite endpoint of first occurrence of death and MI 2.) The risk of the composite endpoint of first occurrence of death, MI, stroke, TIA, coronary revascularization or rehospitalization for unstable angina pectoris 3.) The risk of the composite endpoint of first occurrence of death, MI, or stroke 4.) Mortality 5) Bleeding events 6.) Change (fold induction) in cardio-renal biomarkers from baseline to end of study visit (biomarkers will be measured in PIs core lab at end of study) 7.) Cancer 8.) Disability-free survival |
1.) Kombinierte Endpunkt aus Tod oder AMI 2.) Kombinierter Endpunkt aus Tod, AMI, Schlaganfall, TIA (transitorische ischämische Attacke), koronarer Revaskularisation, oder Hospitalisierung wegen instabiler AP (iAP) 3.) Kombinierter Endpunkt aus Tod, AMI, oder Schlaganfall 4.) Mortalität 5.) Blutungsereignisse 6.) Veränderung von kardio-renalen Biomarkern zwischen Studieneinschluss und Studienende (Bestimmung nach Studienende im Referenzlabor) 7.) Krebserkrankungen 8.) Behinderungsfreies Leben |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Key inclusion criteria: • Patients presenting in the ER/ Chest Pain Unit (CPU), and expected to be discharged within 24 hours • Patients at risk for cardiovascular events as defined by at least one elevated high-sensitive troponin level during clinical work-up (> 90th percentile) • Clinical exclusion of ACS, despite elevated hsTn (e.g. because of missing troponin dynamics) • At least 50 years of age |
Haupteinschlusskriterien: 1. Patienten die sich in der Notaufnahme/ CPU (Chest Pain Unit) vorstellen und voraussichtlich innerhalb von 24 Stunden entlassen werden 2. „At-risk“-Konstellation mit Vorliegen von mindestens einem erhöhten hochsensitiv bestimmten Troponinwert (> 90. Perzentile) 3. Klinischer Ausschluss eines ACS trotz erhöhter Troponinwerte (z.B. wegen fehlender Troponindynamik) 4. Mindestens 50 Jahre alt |
|
E.4 | Principal exclusion criteria |
Key exclusion criteria: • Indication for antiplatelet therapy (e.g transient ischemic attack, or stable coronary artery diseases -CAD) or anticoagulation therapy (such as atrial fibrillation) • Indication for anti-lipid therapy at the discretion of the treating physician (no routine measurement of LDL-cholesterol) • Any known evidence of an acute myocardial necrosis (e.g imaging evidence of new regional wall motion abnormality, or significant ST-segment–T wave (ST–T) changes in ECG) • Untreated, known clinically significant CAD requiring revascularization • Hemoglobin value below 8 mg/d, and/or creatinine kinase ≥3 times ULN, and/or AST or ALT ≥3 times ULN • Active malignancy of any organ system, treated or untreated. Subjects have to be in remission for at least 36 months to be eligible. |
Hauptausschlusskriterien: 1. Indikation zur Therapie mit einem Plättchenhemmer (z.B. TIA oder stabile KHK [koronare Herzkrankheit]) 2. Indikation zur medikamentösen Lipidsenkung (keine studienbedingte Routinebestimmung von LDL-Cholesterol) 3. Nachweis einer akuten Myokardnekrose (z.B. Bildnachweis neuer Wandbewegungsstörungen, oder signifikante STStreckenveränderungen im EKG) 4. Unbehandelte, bekannte klinisch signifikante KHK mit Revaskularisationsbedarf 5. Hämoglobin kleiner 8 mg/dL, und/ oder Kreatininkinase ≥ 3 mal über dem oberen Normalwert, und/ oder Leberwerterhöhung (AST oder ALT) ≥ 3 mal über dem oberen Normalwert 6. Aktive Krebserkrankung, behandelt oder unbehandelt. Eingeschlossen werden dürfen nur Patienten, die sich seit mindestens 36 Monaten in Remission befinden. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy endpoint: Time to MI, coronary revascularization, or death, whatever comes first |
Primärer Wirksamkeitsendpunkt: Zeit bis zum Myokardinfarkt (AMI), bis zur Koronarrevaskularisation, oder Tod - was zuerst eintritt |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
during at least 12 months follow-up |
während mindestens 12 Monaten Follow-up |
|
E.5.2 | Secondary end point(s) |
Key secondary endpoints: The secondary efficacy objectives are to compare the active treatment and placebo groups with respect to: 1.) The risk of the composite endpoint of first occurrence of death and MI 2.) The risk of the composite endpoint of first occurrence of death, MI, stroke, TIA, coronary revascularization or rehospitalization for unstable angina pectoris 3.) The risk of the composite endpoint of first occurrence of death, MI, or stroke 4.) Mortality 5) Bleeding events 6.) Change (fold induction) in cardio-renal biomarkers from baseline to end of study visit (biomarkers will be measured in PIs core lab at end of study) 7.) Cancer 8.) Disability-free survival |
• Kombinierte Endpunkt aus Tod oder AMI • Kombinierter Endpunkt aus Tod, AMI, Schlaganfall, TIA (transitorische ischämische Attacke), koronarer Revaskularisation, oder Hospitalisierung wegen instabiler AP (iAP) • Kombinierter Endpunkt aus Tod, AMI, oder Schlaganfall • Mortalität • Blutungsereignisse • Veränderung von kardio-renalen Biomarkern zwischen Studieneinschluss und Studienende (Bestimmung nach Studienende im Referenzlabor) • Krebserkrankungen • Behinderungsfreies Leben |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
during at least 12 months follow-up |
während mindestens 12 Monaten Follow-up |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |