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L'essai clinique NCT05182970 (MIMET) pour Pré-diabète, Infarctus du myocarde aigu, Infarctus du myocarde sans élévation du segment ST, Infarctus du Myocarde avec Élévation du Segment ST est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Metformin and Prevention of Cardiovascular Events in Patients With Acute Myocardial Infarction and Prediabetes (MIMET)

En recrutement
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L'essai clinique NCT05182970 (MIMET) est conçu pour étudier la prevention de Pré-diabète, Infarctus du myocarde aigu, Infarctus du myocarde sans élévation du segment ST, Infarctus du Myocarde avec Élévation du Segment ST. Il s'agit d'un essai interventionnel en Phase III. Son statut actuel est : en recrutement. L'essai a débuté le 2 décembre 2021 et vise à recruter 5 160 participants. Dirigé par l'Institut Karolinska, l'essai devrait être terminé d'ici le 1 mai 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 2 avril 2024.
Résumé succinct
Prediabetes is associated to an increased risk of cardiovascular disease and mortality. Although metformin can delay progression to diabetes there is a lack of RCTs evaluating the effect of metformin on cardiovascular outcomes. MIMET aims to investigate if addition of metformin to standard care has effects on the occurrence of cardiovascular events after acute myocardial infarction in patients with newly detected prediabetes (identified by oral glucose tolerance test, HbA1c or fasting glucose levels).
Description détaillée
The study is a national multicenter R-RCT associated to the The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART registry) where participants, after informed consent, will be randomly assigned to either open treatment with standard care + metformin or standard care alone in a 1:1 ratio. Standard care consists of diet and life-style advice according to national guidelines but does not include metformin. Baseline data for individual patients will be collected from the SWEDEHEART registry. Patients will be followed per routine care at 2 and 12 months post index AMI and in addition at a final study visit at 24 months. Laboratory measurements and collection of SAE will be performed yearly. In total n=5150 patients is expected to be followed for major CV event (all-cause mortality, myocardial infarction, heart failure and stroke) by linkage with SWEDEHEART and national health registries.
Titre officiel

The Myocardial Infarction and New Treatment With Metformin Study (MIMET) - a R-RCT to Study Metformin and the Prevention of Cardiovascular Events in Patients With Acute Myocardial Infarction and Newly Detected Prediabetes

Conditions
Pré-diabèteInfarctus du myocarde aiguInfarctus du myocarde sans élévation du segment STInfarctus du Myocarde avec Élévation du Segment ST
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • MIMET
  • 2019-05382
Numéro NCT
NCT05182970
Date de début (réel)
2021-12-02
Dernière mise à jour publiée
2024-04-02
Date de fin (estimée)
2026-05
Inscription (estimée)
5 160
Type d'essai
Interventionnel
PHASE
Phase III
Statut
En recrutement
Objectif principal
Prévention
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Comparateur actifMetformin on top of standard care
Metformin will be prescribed by the Investigator at the study site and dispensed at pharmacy of choice by the patient. Metformin will be recommended to be gradually titrated to minimize gastrointestinal side effects with a start dose of 500 mg 1x1 for 1 week and thereafter 500 mg 1x2 with an individualised target dose of 2000 mg daily depending on tolerability. The goal is to a have minimal dose of 500 mg 1x2. Patients will be informed to stop medication in events of sever nausea, vomiting or dehydration according to standard practice. The threshold for metformin titration or adding another drug during follow-up is recommended to be assessed individually by the Investigator at the study site, responsible for the patient. Patients with eGFR \<60 cannot be included in the MIMET study. If GFR is between 30-45 ml/min during the study, metformin should be reduced to 1000 mg daily. Metformin is contraindicated if GFR \<30 ml/min. Standard care will be the same as in the control arm.
Metformine
Individualised target dose of 2000 mg daily depending on tolerability.
Aucune interventionStandard care alone
Standard care according to national guidelines. In Sweden there is no pharmacological intervention recommended for individuals with prediabetes at present. Standard care includes diet and life-style advice, which will be given to both groups in the same manner according to local routines, based on the present guidelines. Secondary preventive treatment includes physical activity, participating in exercise program, dietary habits, BMI and or waist circumference, smoking and EQ-5D will be followed in accordance with the routinely reported SWEDEHEART-SEPHIA variables.
N/A
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Time to major CV event
Major CV event; a composite endpoint of first of all-cause death or main diagnosis of MI, heart failure or stroke (reported in SWEDEHEART, the National Patient Register and the Cause of Death Register).
Estimated follow-up for each patient is 1-4 years
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Time to the composite endpoint CV death, main diagnosis of MI, heart failure or stroke.
Time to first event included in the composite endpoint CV death, main diagnosis of MI, heart failure or stroke.
Estimated follow-up for each patient is 1-4 years
Time to the composite endpoint of all-cause death, main diagnosis of MI, stroke and revascularisation (CABG or PCI >4 months after the index AMI).
Time to first event included in the composite endpoint of all-cause death, main diagnosis of MI, stroke and revascularisation (CABG or PCI \>4 months after the index AMI).
Estimated follow-up for each patient is 1-4 years
All-cause death
Time to all-cause death
Estimated follow-up for each patient is 1-4 years
CV death
Time to CV death
Estimated follow-up for each patient is 1-4 years
Hospitalisation with MI
Time to readmission for MI. Hospital admission for MI during day 0-30 after index AMI will be excluded
Estimated follow-up for each patient is 1-4 years
Hospitalisation with stroke
Time to hospitalisation for stroke (main diagnosis)
Estimated follow-up for each patient is 1-4 years
Hospitalisation with heart failure
Time to hospitalisation for heart failure (main diagnosis)
Estimated follow-up for each patient is 1-4 years
New cancer diagnosis
Time to new cancer diagnosis defined as the first occurrence of any cancer in the National Patient Register
Estimated follow-up for each patient is 1-4 years
Initiation of any glucose lowering therapy
Time to initiation of any glucose lowering therapy (ATC code A10 in the Prescribed Drug Register, excluding randomisation to metformin)
Estimated follow-up for each patient is 1-4 years
Diabetes diagnosis
Defined as diabetes diagnosis in National Patient Register and/or prescribed glucose lowering treatment in the Prescribed Drug Register excluding randomisation to metformin in the active treatment arm
Estimated follow-up for each patient is 1-4 years
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous

I. AMI

II. Swedish citizens with a personal ID number ≥18 years and ≤80 years

III. Newly diagnosed prediabetes:

  1. HbA1c 42-47 mmol/mol or
  2. Capillary or venous fasting plasma glucose concentration 6.1-6.9 mmol/L or
  3. 2-hour post-load capillary glucose concentration 8.9-12.1 mmol/L or
  4. 2-h post-load venous plasma glucose concentration 7.8-11.0 mmol/L
  5. HbA1c <48 mmol/mol and 2-hour post-load capillary glucose concentration >12.1 mmol/L or 2-h post-load venous plasma glucose concentration >11.0 mmol/L (thus elevated 2-hour glucose levels in the diabetes range but without HbA1c levels diagnostic for diabetes)

IV. Naïve to metformin and other glucose lowering therapy

V. Signed informed consent

I. Type 1 diabetes

II. Known type 2 diabetes

III. Indication for glucose lowering treatment

IV. Acute condition with high risk for volume depletion, circulatory shock, hypoxia

V. Serious illness, other than cardiovascular, with short life expectancy

VI. Renal failure (eGFR <60ml/min)

VII. Hepatic failure

VIII. Malignancy within the last year

IX. Contraindication or hypersensitivity to the study drug

X. Alcohol or drug abuse

XI. Pregnancy or breastfeeding

XII. Women of childbearing potential without adequate anticonception during any part of the study period

XIII. Previous hospitalisation for lactic acidosis

XIV. Predicted inability to comply with the study protocol

Karolinska Institutet logoInstitut Karolinska463 essais cliniques actifs à explorer
Partie responsable de l'essai
Anna Norhammar, Investigateur principal, Professor, Karolinska Institutet
Contact central de l'essai
Contact: Anna Norhammar, MD, Prof., +46858701568, [email protected]
Contact: Viveca Ritsinger, MD, PhD, +46372585000, [email protected]
1 Centres de l'essai dans 1 pays
Medicinkliniken, Ljungby Hospital, Ljungby, 341 35, Sweden
Thomas Aronsson, Head of Clinic, Contact
Viveca Ritsinger, MD PhD, Investigateur principal
En recrutement