A Phase 4 interventional study of Metoprolol Succinate and Bisoprolol in Acute Myocardial Infarction, Non-ST Elevation Myocardial Infarction and ST Elevation Myocardial Infarction, sponsored by Karolinska Institutet. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Karolinska Institutet · Phase 4, Interventional, and Treatment
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Among 17 studies in Non-ST Elevated Myocardial Infarction with a site in Sweden — 2 open to participants now, 6 under way, 1 of them phase 3. Non-ST Elevated Myocardial Infarction · Sweden.
Among the 17 studies in Non-ST Elevated Myocardial Infarction with a site in Sweden, this one is the 6th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2017, is one of 3 in phase 4, and was the 11th registered.
284 studies on the registry are indexed under Non-ST Elevated Myocardial Infarction; 52 are open to participants now.
Browse Non-ST Elevated Myocardial Infarction studies →2 of the 17 studies in Non-ST Elevated Myocardial Infarction with a site in Sweden are open now. Recruiting first, the newest first:
Region Stockholm · Sites in Sweden
Ages 18+
Karolinska Institutet · Sites in Sweden
Ages 18–80
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 40 Non-ST Elevated Myocardial Infarction studies recruiting now, 34 (85%) set no upper age limit and 1 (3%) stops at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 5,000 is above the median of 244 across 146 interventional studies indexed under Non-ST Elevated Myocardial Infarction.
Median enrollment 5,000 across the 11 interventional studies, 357 across the 6 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
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6 of 17 have an industry lead sponsor. The 10 most frequent:
Karolinska Institutet is the lead sponsor of 1,149 studies on the registry; 277 are open to participants now.
Karolinska Institutet has 5 studies filed under Non-ST Elevated Myocardial Infarction — fewer than ten, so there is no comparison to draw.
2 of the studies in Non-ST Elevated Myocardial Infarction with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06566625Region StockholmCardiac MRI Prior to Invasive Coronary Angiography in Patients With Suspected Non-ST-Elevation Myocardial Infarction | 2026-12-31 |
| NCT05284747AmgenEVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction | 2027-05-29 |
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Among the 17 studies in Non-ST Elevated Myocardial Infarction with a site in Sweden, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Long-term beta-blocker therapy has not been investigated in contemporary randomized clinical trials in patients with myocardial infarction and normal heart function. The aim of this study is to determine whether long-term treatment with oral beta-blockade in patients with myocardial infarction and preserved left ventricular systolic ejection fraction reduces the composite of death of any cause or new myocardial infarction..
REDUCE-SWEDEHEART is designed as a registry-based, randomized, parallel, open-label, multicenter trial.
Patients, day 1-7 after myocardial infarction, who have undergone a coronary angiography and with preserved left ventricular systolic ejection fraction will be randomized to either oral beta-blockade (see "Intervention" for detailed description) at a dose according to the treating physician, or no beta-blockade. To allow quick inclusion the randomization module will be accessible by a simple web-based log-in procedure. Concomitantly, all baseline data about each individual patient will be collected from the SWEDEHEART registry. Patients will then be followed regarding all-cause mortality, myocardial infarction, heart failure, atrial fibrillation, and patient-related outcome measures (for a subgroup of patients). Patients that are eligible but not included in REDUCE-SWEDEHEART will also be followed regarding chosen treatment and the primary and secondary endpoints.
Follow-up will continue until 379 primary endpoints have been observed (endpoint driven). All analyses will be performed on the intention-to-treat set, defined as all intentionally randomized patients, by randomized treatment. The primary endpoint is death or new MI. Information about death will be obtained from the Swedish population registry. Information regarding new myocardial infarction during hospitalization and readmission because of myocardial infarction or other outcome (secondary outcomes, see section below), will be obtained from the SWEDEHEART-registry (for myocardial infarction) and the patient registry of the National board of health and welfare.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to beta-blockade will be prescribed oral beta-blocker (metoprolol succinate or bisoprolol) at a dose according to the treating physician. Metoprolol succinate will be strongly recommended as first choice. Bisoprolol will be allowed as an alternative. Atenolol (or any other beta-blocker therapy) will not be allowed. The treating physician will be encouraged to aim for a dose of ≥ 100 mg for metoprolol succinate and ≥ 5 mg for bisoprolol. Prescribed treatment and dosing will be registered. Initiation (whether the prescribed drug is dispensed) and adherence (defined as proportion of prescribed tablets that are dispensed), and persistence (time on treatment) will also be recorded via the Drug prescription registry.
Drug: Metoprolol Succinate · Drug: Bisoprolol
Patients randomized to no beta-blockade will be discouraged to use beta-blockade as long as there is no other indication than strictly secondary prevention after myocardial infarction. Patients assigned to no beta-blockade also receive best evidence-based care, without beta-blockers. For blood pressure control, other drugs than beta-blockers will be recommended as first-line treatment. Regarding later use of beta-blockade, follow up is performed in the Drug prescription registry. Patients will be asked to provide future physicians with the written information about the study when beta-blockade treatment is discussed.
Eligible patients randomized to active treatment will receive long-term oral beta-blockade (metoprolol succinate or bisoprolol).
Please see the section above.
Time to the composite of death of any cause or MI
Time to the composite of death of any cause or MI on an intention to treat basis (ITT)
Time frame: through study completion, an average of 3 year
All-cause death
Time to the individual component of the primary endpoint of any cause of death.
Time frame: through study completion, an average of 3 year
Myocardial infarction
Time to the individual component of the primary endpoint of MI.
Time frame: through study completion, an average of 3 year
Cardiovascular death
Time to cardiovascular death.
Time frame: through study completion, an average of 3 year
Heart failure
Time to hospital readmission due to heart failure (primary \[main\] diagnosis)
Time frame: through study completion, an average of 3 year
Atrial fibrillation
Time to hospital readmission due to atrial fibrillation (primary \[main\] diagnosis)
Time frame: through study completion, an average of 3 year
Bradycardia, Advanced AV-block, hypotension, syncope or need for pacemaker
Time to hospital readmission due to bradycardia or advanced AV-block or hypotension or syncope or need for pacemaker (primary \[main\] diagnosis)
Time frame: through study completion, an average of 3 year
Asthma or Chronic Obstructive Pulmonary Disease
Time to hospital readmission due to asthma or chronic obstructive pulmonary disease (primary \[main\] diagnosis)
Time frame: through study completion, an average of 3 year
Stroke
Time to hospital readmission due to stroke (primary \[main\] diagnosis)
Time frame: through study completion, an average of 3 year
Health related quality of life (HRQOL)
Health related quality of life (HRQOL) measured by EQ-5D in patients younger than 75 years of age
Time frame: Estimated maximal follow-up for each patient for this outcome is 1 year.
Health care costs
Health care cost analysis concerning the use beta-blocker treatment
Time frame: through study completion, an average of 3 year
Anxiety and depression
Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 8 weeks and 12 months after randomization
Wellbeing
Wellbeing measured by WHO-5 Wellbeing Index
Time frame: 8 weeks and 12 months after randomization
Cardiac Anxiety
Cardiac Anxiety measured by Cardiac Anxiety Questionnaire (CAQ)
Time frame: 8 weeks and 12 months after randomization
Sexual function
Sexual function measured by Arizona Sexual Experiences Scale (ASEX)
Time frame: 8 weeks and 12 months after randomization
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Nov 2023, 74 months.
Of 23 phase 4 interventional studies under Non-ST Elevated Myocardial Infarction, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 74. This study's 74 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Metoprolol · Bisoprolol
Non-ST Elevated Myocardial Infarction →