Myocardial InfarctionPhase 4REMINDERNCT01176968
Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction
A Phase 4 study testing Eplerenone in people with Myocardial Infarction, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 75 sites in 11 countries.
Trial summary
Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Eplerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,012 participants
- Where
- 75 sitesin 11 countries
- Study dates
- Sep 2010to Oct 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have experienced a myocardial infarction (STEMI) within the previous 24 hours confirmed by symptoms and ECG.
Who cannot join
- Subjects with a known low ejection fraction of less than 40% or any previous history of heart failure.
- Subjects treated with eplerenone or other aldosterone antagonists within the past 1 month.
- The subject has uncontrolled hypotension (SBP<90mmHg).
- Subjects with eGFR ≤30ml/min (based on admission serum creatinine and the MDRD formula) or serum creatinine ≥220µmol/L.
Trial locations and contacts
75 sites in 11 countries.
75 sites in 11 countries
Germany13 sites
Universitaets-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, 79189
Charite - Universitaetsmedizin Berlin
Berlin, 12200
Universitätsklinikum Bonn
Bonn, 53127
Klinikum Links der Weser gGmbH
Bremen, 28277
Sankt Johannes Hospital Medizinische Klinik I
Dortmund, 44137
Sankt Johannes Hospital
Dortmund, 44137
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
Dresden, 01309
Georg-August-Universitaet Goettingen, Zentrum f. Innere Medizin / Kardiologie u. Pneumologie
Göttingen, 37075
Universitaeres Herzzentrum Hamburg
Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, 30625
St. Vincenz Krankenhaus
Limburg, 65549
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131
Staedtisches Klinikum Muenchen GmbH Klinikum Neuperlach
Munich, 81737
Canada11 sites
Centre de Sante et de Services Sociaux de Chicoutimi (CSSSC) (Complexe Hospitalier de la Sagamie)
Chicoutimi, Quebec, G7H 5H6
ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi
Chicoutimi, Quebec, G7H 7P2
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Walter C Mackenzie Health Sciences Centre (WCM)
Edmonton, Alberta, T6G 2B7
Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
Health Sciences Center, Eastern Health
St. John's, Newfoundland and Labrador, A1B 3V6
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Diamond Health Care Centre (DHCC)
Vancouver, British Columbia, V5Z 1M9
Vancouver General Hospital - Centennial Pavilion
Vancouver, British Columbia, V5Z 1M9
Vancouver General Hospital, Vancouver Coastal Health Authority
Vancouver, British Columbia, V5Z 1M9
United Kingdom10 sites
City Hospital
Birmingham, B18 7QH
Blackpool Victoria Hospital NHS Trust , Cardiac Research ,Lancashire Cardiac Centre
Blackpool, Lancashire, FY3 8NR
Academic cardiology Unit
Cottingham Hull, HU16 5JQ
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, CV2 2DX
Ninewells Hospital and Medical School
Dundee, DD1 9SY
Edinburgh Royal Infirmary
Edinburgh, Lothian, EH16 4SA
The Queens Medical Research Institute- University of Edinburgh
Edinburgh, EH16 4TJ
University Hospital of Leicester (UHL) NHS Trust
Leicester, LE3 GQP
Clinical Trials Unit Morriston Hospital
Swansea, Wales, SA6 6NL
Clinical Trials Unit, Morriston Hospital
Swansea, SA6 6NL
France9 sites
Service Cardiologie, Centre Hospitalier de Cannes
Cannes, 06401
Hôpital Henri Mondor - Pysiologie explorations fonctionnelles
Créteil, 94010
Hôpital Henri Mondor
Créteil, 94010
Chu du Bocage - Centre de Cardiologie
Dijon, Cedex, 21034
Centre de Cardiologie d'Evecquemont
Évecquemont, 78740
Service Cardiologie Hopital Robert Boulin
Libourne, 33500
Hopital De La Pitie Salpetriere
Paris, Cedex, 75013
Cardiologie Interventionnelle
Pessac, 33604
Chu Rangueil Service de Cardiologie, A - Bat H1
Toulouse, Cedex 4, 31403
Czechia7 sites
Fakultni nemocnice Brno
Brno, 62500
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005
I.Interni klinika-kardiologie FN Olomouc
Olomouc, 775 20
I. Interni klinika - kardiologie FN Olomouc
Olomouc, 77520
Klinika kardiologie IKEM
Prague, 140 21
Nemocnice Na Homolce - kardiologicke oddeleni
Prague, 150 30
Spain7 sites
"Hospital Clinic i Provincial de Barcelona,Instituto Clinic del Torax
Barcelona, 08036
Hospital del Mar.
Barcelona, 8003
Hospital Del Sas de Jerez de La Frontera
Jerez de la Frontera, Cadiz, 11407
HOSPITAL CLINICO SAN CARLOS- Universidad Complutense de Madrid
Madrid, 28040
Hospital Universitario de La Paz
Madrid, 28046
Hospital Universitari Son Espases
Palma de Mallorca, 07010
Hospital General Universitario de Valencia
Valencia, 46014
Slovakia5 sites
Stredoslovensky ustav srdcovych a cievnych chorob, a.s.
Banská Bystrica, 974 01
Narodny ustav srdcovych a cievnych chorob, a.s.
Bratislava, 833 48
Univerzitna nemocnica Martin
Martin, 036 59
Kardiocentrum Nitra, s.r.o.
Nitra, 949 01
Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, 979 12
Hungary4 sites
Budai Irgalmasrendi Korhaz, Kardiologia
Budapest, 1027
Petz Aladar Megyei Oktato Korhaz, Kardiologiai Osztaly
Győr, 9024
Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Kardiologia
Nyíregyháza, 4400
Zala Megyei Korhaz, Kardiologia
Zalaegerszeg, 8900
Poland4 sites
Katedra i Klinika Kardiologii i Chorob Wewnetrznych
Bydgoszcz, 85-094
Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10-561
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ w Oswiecimiu G.V.M CARINT Sp. zo.o.
Oświęcim, 32-600
Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny We Wroclawiu
Wroclaw, 51-124
Greece3 sites
General Hospital of Athens "Georgios Gennimatas"
Athens, 11527
General Hospital of Attiki KAT
Athens, 14561
University General Hospital of Patra
Rio Patra, 26500
Netherlands2 sites
Onze Lieve Vrouwe Gasthuis, Locatie Oosterpark
Amsterdam, 1091 AC
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction
Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity.
- Conditions
- Myocardial Infarction
- Being tested
- Eplerenone, Placebo
- Keywords
- Eplerenone, myocardial infarction, mortality, morbidity
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Also called Inspra
Maximum dose of 2x25 mg film coated tablets per day for the duration of the study (approximately 18 months maximum). Lower doses may be administered determined by blood biochemistry data.
PlaceboDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Eplerenone plus standard of care | Experimental | Not described Receives: Drug: Eplerenone |
| Placebo plus standard of care | Placebo comparator | Matching placebo for eplerenone 25mg film coated tablets. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off
Cardiovascular mortality is defined as any mortality adjudicated as death due to sudden cardiac death, myocardial infarction (MI), worsening heart failure, cardiac arrhythmia, other cause (such as pulmonary embolism, peripheral arterial disease [PAD], etc.). Hospitalization due to congestive heart failure (CHF) and requires extended hospital stay or frequent visits to emergency room, observation unit or in-patient care, due to CHF as the primary or secondary diagnosis supported by a discharge report or clinical summary for hospitalization as determined by the endpoint adjudication committee (EAC). A composite of time to first event of cardiovascular mortality (CV), re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40% after 1 month or BNP >200 pg/mL or NT-proBNP >450 pg/mL (age <50 years); >900 pg/mL (age 50 to 75 years) or >1800 pg/mL (age >75 years) after 1 month.
Measured: 0-24 months
Secondary outcomes (13)
Cardiovascular Mortality
The occurrence of cardiovascular mortality from randomization. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Measured: 0-24 months
Diagnosis of Heart Failure
The occurrence of first diagnosis of heart failure from the date of randomization. Time-to-event analyses were measured from the date of randomization, and a subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Measured: 0-24 months
First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.
The occurrence of first and each subsequent episode (after an event-free interval of ≥ 48 hours) of sustained ventricular tachycardia or ventricular fibrillation. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Measured: 0-24 months
First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).
The occurrence of first recorded EF ≤40% (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Measured: 0-24 months
Brain (B-type) Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for Ages <50 Years, 50-75 Years and >75 Years, Respectively (Recorded 1 Month or Later Post-randomization).
The occurrence of first occurrence of BNP >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for ages <50 years, 50 to 75 years and >75 years, respectively (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Measured: 0-24 months
Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).
The decision to provide an ICD or CRT. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Measured: 0-24 months
Second or Subsequent Non-fatal Myocardial Infarction (MI).
The occurrence of second or subsequent nonfatal MI. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Measured: 0-24 months
Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.
Electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) duration at 6 months post-randomization. The continuous endpoints were assessed using analysis of covariance (ANCOVA) model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on last observation carried forward (LOCF) and also using all available data up to end of study.
Measured: 6 months
Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).
LAD recorded each time an echocardiogram is conducted. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.
Measured: 0-24 months
Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.
Change in serum levels of aldosterone and cortisol at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.
Measured: 6 months
Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.
Change in serum levels of PIIINP, Galectin 3, and PINP at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.
Measured: 6 months
Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.
Change in serum level of ICTP at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.
Measured: 6 months
Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.
Change in serum level of Interleukin-6 at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176968
- Sponsor's protocol ID
- A6141116
- Other IDs
- 2010-019844-38, REMINDER
- Acronym
- REMINDER
- Status last verified
- Dec 2020
- First submitted
- 4 Aug 2010
- Last updated
- 22 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Montalescot G, Pitt B, Lopez de Sa E, Hamm CW, Flather M, Verheugt F, Shi H, Turgonyi E, Orri M, Vincent J, Zannad F; REMINDER Investigators; REMINDER Investigators. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: the Randomized Double-Blind Reminder Study. Eur Heart J. 2014 Sep 7;35(34):2295-302. doi: 10.1093/eurheartj/ehu164. Epub 2014 Apr 29.
PubMed 24780614
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01176968
- Acronym / sponsor ID
- REMINDER / A6141116
- Conditions
- Myocardial Infarction
- Keywords
- Eplerenone, myocardial infarction, mortality, morbidity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Posted 15 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eplerenone plus standard of care | Experimental | Drug: Eplerenone |
| Placebo plus standard of care | Placebo comparator | Drug: PlaceboMatching placebo for eplerenone 25mg film coated tablets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must have experienced a myocardial infarction (STEMI) within the previous 24 hours confirmed by symptoms and ECG.
Key exclusion criteria (4 listed)
- Subjects with a known low ejection fraction of less than 40% or any previous history of heart failure.
- Subjects treated with eplerenone or other aldosterone antagonists within the past 1 month.
- The subject has uncontrolled hypotension (SBP<90mmHg).
- Subjects with eGFR ≤30ml/min (based on admission serum creatinine and the MDRD formula) or serum creatinine ≥220µmol/L.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EplerenoneAlso: InspraMaximum dose of 2x25 mg film coated tablets per day for the duration of the study (approximately 18 months maximum). Lower doses may be administered determined by blood biochemistry data. | Drug | Eplerenone plus standard of care |
| PlaceboMatching placebo tablets | Drug | Placebo plus standard of care |
Primary outcome
First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off
Time frame: 0-24 months
Cardiovascular mortality is defined as any mortality adjudicated as death due to sudden cardiac death, myocardial infarction (MI), worsening heart failure, cardiac arrhythmia, other cause (such as pulmonary embolism, peripheral arterial disease [PAD], etc.). Hospitalization due to congestive heart failure (CHF) and requires extended hospital stay or frequent visits to emergency room, observation unit or in-patient care, due to CHF as the primary or secondary diagnosis supported by a discharge report or clinical summary for hospitalization as determined by the endpoint adjudication committee (EAC). A composite of time to first event of cardiovascular mortality (CV), re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40% after 1 month or BNP >200 pg/mL or NT-proBNP >450 pg/mL (age <50 years); >900 pg/mL (age 50 to 75 years) or >1800 pg/mL (age >75 years) after 1 month.
13 secondary outcomes
Cardiovascular Mortality
Time frame: 0-24 months
Diagnosis of Heart Failure
Time frame: 0-24 months
First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.
Time frame: 0-24 months
First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).
Time frame: 0-24 months
Brain (B-type) Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for Ages <50 Years, 50-75 Years and >75 Years, Respectively (Recorded 1 Month or Later Post-randomization).
Time frame: 0-24 months
Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).
Time frame: 0-24 months
Second or Subsequent Non-fatal Myocardial Infarction (MI).
Time frame: 0-24 months
Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.
Time frame: 6 months
Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).
Time frame: 0-24 months
Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.
Time frame: 6 months
Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.
Time frame: 6 months
Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.
Time frame: 6 months
Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24780614Montalescot G, Pitt B, Lopez de Sa E, Hamm CW, Flather M, Verheugt F, Shi H, Turgonyi E, Orri M, Vincent J, Zannad F; REMINDER Investigators; REMINDER Investigators. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: the Randomized Double-Blind Reminder Study. Eur Heart J. 2014 Sep 7;35(34):2295-302. doi: 10.1093/eurheartj/ehu164. Epub 2014 Apr 29.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
75 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eplerenone in people with Myocardial Infarction, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 75 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in Germany, Canada, United Kingdom, France, Czechia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off (time frame: 0-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01176968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.