- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02268669
Comparison of Primary PCI vs. Post-thrombolysis PCI as Reperfusion Strategies in STEMI (GRACIA4)
A Randomized Clinical Trial Comparing Primary PCI and Post-thrombolysis PCI as Reperfusion Strategies in Patients With ST Segment Elevation Acute Myocardial Infarction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
Two different reperfusion strategies in STEMI will be compared: primary angioplasty vs. post-thrombolysis angioplasty
|
Active Comparator: 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
|
Two different reperfusion strategies in STEMI will be compared: primary angioplasty vs. post-thrombolysis angioplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of death
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 12 months
|
12 months
|
|
Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage
Time Frame: 30 days
|
30 days
|
|
Incidence of major bleeding events
Time Frame: 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)
Time Frame: 12 months
|
12 months
|
|
Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage
Time Frame: 3 years
|
3 years
|
|
Incidence of death
Time Frame: 3 years
|
3 years
|
|
Incidence of reinfarction
Time Frame: 3 years
|
3 years
|
|
Incidence of new revascularization
Time Frame: 3 years
|
3 years
|
|
Incidence of rehospitalization
Time Frame: 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.)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Francisco Fernandez-Aviles, MD, PhD, faviles@secardiologia.es
Publications and helpful links
General Publications
- Fernandez-Aviles F, Alonso JJ, Pena G, Blanco J, Alonso-Briales J, Lopez-Mesa J, Fernandez-Vazquez F, Moreu J, Hernandez RA, Castro-Beiras A, Gabriel R, Gibson CM, Sanchez PL; GRACIA-2 (Groupo de Analisis de Cardiopatia Isquemica Aguda) Investigators. Primary angioplasty vs. early routine post-fibrinolysis angioplasty for acute myocardial infarction with ST-segment elevation: the GRACIA-2 non-inferiority, randomized, controlled trial. Eur Heart J. 2007 Apr;28(8):949-60. doi: 10.1093/eurheartj/ehl461. Epub 2007 Jan 23.
- Fernandez-Aviles F, Alonso JJ, Castro-Beiras A, Vazquez N, Blanco J, Alonso-Briales J, Lopez-Mesa J, Fernandez-Vazquez F, Calvo I, Martinez-Elbal L, San Roman JA, Ramos B; GRACIA (Grupo de Analisis de la Cardiopatia Isquemica Aguda) Group. Routine invasive strategy within 24 hours of thrombolysis versus ischaemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1): a randomised controlled trial. Lancet. 2004 Sep 18-24;364(9439):1045-53. doi: 10.1016/S0140-6736(04)17059-1.
- Sanchez PL, Gimeno F, Ancillo P, Sanz JJ, Alonso-Briales JH, Bosa F, Santos I, Sanchis J, Bethencourt A, Lopez-Messa J, de Prado AP, Alonso JJ, San Roman JA, Fernandez-Aviles F. Role of the paclitaxel-eluting stent and tirofiban in patients with ST-elevation myocardial infarction undergoing postfibrinolysis angioplasty: the GRACIA-3 randomized clinical trial. Circ Cardiovasc Interv. 2010 Aug;3(4):297-307. doi: 10.1161/CIRCINTERVENTIONS.109.920868.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRACIA4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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