E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Long-term treatment with beta-blockers in patients with myocardial infarction and preserved ejection fraction. |
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E.1.1.1 | Medical condition in easily understood language |
Long-term treatment with beta-blockers in patients with myocardial infarction and preserved ejection fraction. |
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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 long-term treatment with oral beta-blockade in patients with MI and preserved LV systolic ejection fraction reduces the composite of death of any cause or new MI |
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E.2.2 | Secondary objectives of the trial |
To determine whether long-term treatment with oral beta-blockade in patients with MI and preserved LV systolic ejection fraction reduces:
-All-cause mortality.
-Cardiovascular mortality.
-New MI.
-Readmission because of atrial fibrillation.
-Readmission because of heart failure.
To determine whether long-term treatment with oral beta-blockade in patients with MI and preserved LV systolic ejection fraction influences the risk of readmission to hospital because of:
-Bradycardia, Av-block II-III, hypotension, syncope or need for pacemaker.
-Asthma or chronic obstructive pulmonary disease.
-Stroke.
To determine whether long-term treatment with oral beta-blockade in patients with MI and preserved LV systolic ejection fraction affects PROMs and Health care costs in patients registered in SEPHIA |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Age ≥ 18 years.
2.Day 1-7 after MI as defined by the universal definition of MI, type 1, included in the SWEDEHEART registry.
3.Coronary angiography performed during hospitalization.
4.Obstructive coronary artery disease documented by coronary angiography, i.e. stenosis ≥ 50 %, FFR ≤ 0.80 or iFR ≤ 0.89 in any segment at any time point before randomization.
5.Echocardiography performed after the MI showing a normal ejection fraction (EF≥50%).
6.Written informed consent obtained
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E.4 | Principal exclusion criteria |
1.Any condition that may influence the patient’s ability to comply with study protocol.
2.Contraindications for beta-blockade
3.Indication for beta-blockade other than as secondary prevention according to the treating physician
Thus, use of oral beta-blockade on admission is not per se an exclusion criterion.
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to the composite of death of any cause or MI |
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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) |
a All-cause death
b Cardiovascular death
c MI
d Atrial fibrillation (primary [main] diagnosis)
e Heart failure (primary [main] diagnosis)
f Bradycardia, Advanced AV-block, hypotension, syncope or need for pacemaker
g Asthma or Chronic Obstructive Pulmonary Disease (primary [main] diagnosis)
h Stroke
i PROMs: symptoms (angina, dyspnea), functional status (CCS class and NYHA class) and health related quality of life (EQ-5D) after 6-10 weeks and after 1 year of treatment. Health related quality of life (HRQOL) measured by EQ-5D in patients younger than 75 years of age.
Health care costs
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
a-c Time to event
d-h Time to admission to hospital
i After 6-10 weeks and after 1 year of treatment. |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 50 |
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
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This study is event driven, follow-up will continue until 944 primary endpoints have been observed. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |