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Comparison of Primary PCI vs. Post-thrombolysis PCI as Reperfusion Strategies in STEMI (GRACIA4)

16 octobre 2014 mis à jour par: Pedro L Sanchez, GRACIA Group

A Randomized Clinical Trial Comparing Primary PCI and Post-thrombolysis PCI as Reperfusion Strategies in Patients With ST Segment Elevation Acute Myocardial Infarction

The conceptual hypothesis of this study is that primary angioplasty is superior to a combined strategy of immediate thrombolysis followed by routine angioplasty in patients with ST-segment elevation acute myocardial infarction (STEMI), even with the inherent delay of the transfer of these patients.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

This is a randomized, multicenter, open-label clinical trial comparing two strategies of reperfusion in STEMI. Patients will be randomly allocated to: primary angioplasty or post-thrombolysis angioplasty. A clinical follow-up will be performed at 12 months. In this trial, 1444 patients with STEMI will be randomized to primary angioplasty with immediate stent implantation in at least the infarct related artery (IRA) under bivalirudin protection, or to a combined strategy of immediate thrombolysis with tenecteplase (TNK) and enoxaparin followed by cardiac catheterization and adequate revascularization when indicated during the next morning after randomization.

Primary endpoint:

To compare the clinical efficacy (incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage within 12 months) of primary angioplasty versus thrombolytic treatment followed by percutaneous coronary intervention (PCI) the next day in patients with STEMI.

Secondary endpoints:

  • Components of the composite endpoint individually analysed at 12 months (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
  • Cardiovascular mortality and its different components (pre-specified in the case report forms, CRF) at 12 months.
  • Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage at 30 days.
  • Incidence of major bleeding events during hospitalization and at 30 days.
  • To compare the clinical efficacy of both treatments according to the timing of presentation after symptom onset (0 to 3 hours, >3-6 hours, and >6-12 hours), to the patient´s age (> or < 75 years), to the infarction localization (anterior or inferior), to gender (male or female), to the presence of diabetes mellitus and to the characteristics of the recruiting center (with or without 24-hour catheterization facilities).
  • Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage at 3 years.
  • Components of the composite endpoint individually analysed at 3 years (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
  • Analysis of stent thrombosis according to the Academic Research Consortium (ARC) definition (http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4253t2.rtf.) within 30 days, 12 months and 3 years.
  • To compare the combination of death, reinfarction, revascularization, rehospitalization and/or major hemorrhage of patients treated with primary angioplasty versus those assigned to the postrombolysis angioplasty who underwent catheterization the following day within 30 days, 12 months and 3 years.
  • To compare every indivicual components of the combine endpoint (death, reinfarction, revascularization, rehospitalization and major hemorrhage) of patients treated with primary angioplasty versus those assigned to the postrombolysis angioplasty who underwent catheterization the following day within 30 days, 12 months and 3 years.
  • To compare the cost-effectiveness relationship (cost of maintaining a patient alive and without adverse cardiovascular events within the first year post-infarction) of both strategies.

Type d'étude

Interventionnel

Inscription (Réel)

1444

Phase

  • Phase 4

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Age >18 years
  • Chest discomfort > 30 minutes with no response to nitroglycerin
  • Time from the onset of symptoms to randomization between 0 and 12 hours
  • ST segment elevation > 1 mm in two or more contiguos precordial leads or non-diagnostic ECG (left bundle branch block or pacemarker rhythm) with classic symptoms.
  • Killip class equal or less than 3
  • Written informed consent

Exclusion Criteria:

  • Cardiogenic shock defined as a systolic blood pressure <90 mm Hg without response to fluid administration or <100 mm Hg in patients with supportive treatment and no bradycardia
  • Suspicion or evidence of mechanical complications of STEMI
  • Non-cardiac disease that is likely to jeopardize compliance with follow-up schedule of the study (life expectancy < 1 year)
  • woman of childbearing potential unless a negative pregnant test
  • Major contraindications for thrombolytic therapy
  • Participation in other trial
  • Known multivessel disease identified as unsuitable for revascularization
  • Known peripheral vascular disease that complicates cardiac catheterization

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Primary angioplasty
Patients assigned to this treatment will undergo cardiac catheterization within the time recommended by current guidelines. Double antiagregation will be used, vascular access wil be obtained and bivalirudin will be used as anticoagulation; all following current guidelines recommendations
Autre: Reperfusion strategies
Two different reperfusion strategies in STEMI will be compared: primary angioplasty vs. post-thrombolysis angioplasty
Comparateur actif: Post-thrombolysis angioplasty
Patients will receive tenecteplase, enoxaparin, and double antiagreagation with clopidogrel or aspirin as recommended guidelines. Criteria of no reperfusion after fibrinolysis is defined as absence of ST-segment lowering >50%, 90 minutes after fibrinolysis. If not reperfusion is achieved recue angiplasty will be performed inmmediately if reperfusion is achieved cardiac catheterization will be performed the mornig following the day of randomization
Autre: Reperfusion strategies
Two different reperfusion strategies in STEMI will be compared: primary angioplasty vs. post-thrombolysis angioplasty

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage
Délai: 12 months
To compare the clinical efficacy (incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage within 12 months) of primary angioplasty versus post-thrombolytic angioplasty
12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of death
Délai: 12 months
Components of the composite endpoint individually analysed at 12 months (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
12 months
Incidence of myocardial reinfaction
Délai: 12 months
Components of the composite endpoint individually analysed at 12 months (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
12 months
Incidence of new revascularization
Délai: 12 months
Components of the composite endpoint individually analysed at 12 months (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
12 months
Incidence of rehospitalization
Délai: 12 months
Components of the composite endpoint individually analysed at 12 months (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
12 months
Incidence of cardiovascular mortality
Délai: 12 months
12 months
Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage
Délai: 30 days
30 days
Incidence of major bleeding events
Délai: Hospitalization and at 30 days
Hospitalization and at 30 days
clinical efficacy according to timing of presentation (<3, 3-6, and >6 hours), patient´s age (> or < 75 years), infarction localization, gender, presence of diabetes and recruiting center (with or without catheterization facilities)
Délai: 12 months
12 months
Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage
Délai: 3 years
3 years
Incidence of death
Délai: 3 years
3 years
Incidence of reinfarction
Délai: 3 years
3 years
Incidence of new revascularization
Délai: 3 years
3 years
Incidence of rehospitalization
Délai: 3 years
3 years
Analysis of stent thrombosis according to the Academic Research Consortium (ARC) definition (http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4253t2.rtf.)
Délai: 30 days, 12 months and 3 years
30 days, 12 months and 3 years
Combination of death, reinfarction, revascularization, rehospitalization and/or major hemorrhage of patients treated with primary angioplasty vs. those assigned to postrombolysis angioplasty undergoing catheterization the following day
Délai: 30 days, 12 months and 3 years
30 days, 12 months and 3 years
To compare every indivicual components of the combine endpoint of patients treated with primary angioplasty versus those assigned to the postrombolysis angioplasty who underwent catheterization the following day
Délai: 30 days, 12 months and 3 years
30 days, 12 months and 3 years
To compare the cost-effectiveness relationship (cost of maintaining a patient alive and without adverse cardiovascular events within the first year post-infarction) of both strategies
Délai: 12 months
12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

GRACIA Group

Les enquêteurs

  • Chaise d'étude: Francisco Fernandez-Aviles, MD, PhD, faviles@secardiologia.es

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2010

Achèvement primaire (Réel)

1 octobre 2014

Achèvement de l'étude (Anticipé)

1 mars 2016

Dates d'inscription aux études

Première soumission

13 octobre 2014

Première soumission répondant aux critères de contrôle qualité

16 octobre 2014

Première publication (Estimation)

20 octobre 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

20 octobre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 octobre 2014

Dernière vérification

1 octobre 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GRACIA4

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