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

16 oktober 2014 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

1444

Fas

  • Fas 4

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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
Övrig: Reperfusion strategies
Two different reperfusion strategies in STEMI will be compared: primary angioplasty vs. post-thrombolysis angioplasty
Aktiv komparator: 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
Övrig: Reperfusion strategies
Two different reperfusion strategies in STEMI will be compared: primary angioplasty vs. post-thrombolysis angioplasty

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of death
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 12 months
12 months
Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage
Tidsram: 30 days
30 days
Incidence of major bleeding events
Tidsram: 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)
Tidsram: 12 months
12 months
Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage
Tidsram: 3 years
3 years
Incidence of death
Tidsram: 3 years
3 years
Incidence of reinfarction
Tidsram: 3 years
3 years
Incidence of new revascularization
Tidsram: 3 years
3 years
Incidence of rehospitalization
Tidsram: 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.)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 12 months
12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GRACIA Group

Utredare

  • Studiestol: Francisco Fernandez-Aviles, MD, PhD, faviles@secardiologia.es

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2010

Primärt slutförande (Faktisk)

1 oktober 2014

Avslutad studie (Förväntat)

1 mars 2016

Studieregistreringsdatum

Först inskickad

13 oktober 2014

Först inskickad som uppfyllde QC-kriterierna

16 oktober 2014

Första postat (Uppskatta)

20 oktober 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

20 oktober 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 oktober 2014

Senast verifierad

1 oktober 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GRACIA4

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