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

NCT02268669 | Unknown Phase 4 DMC

• 1 other identifier: GRACIA4
• Study Type: interventional
• Target: 1,444
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myocardial Infarction

Keywords

primary angioplasty; post-thrombolysis angioplasty; ST elevation acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

• incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage

  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 Outcomes (17)

• Incidence of death

  12 months

• Incidence of myocardial reinfaction

  12 months

• Incidence of new revascularization

  12 months

• Incidence of rehospitalization

  12 months

• Incidence of cardiovascular mortality

  12 months

Study Arms (2)

Primary angioplasty

ACTIVE COMPARATOR

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

Other: Reperfusion strategies

Post-thrombolysis angioplasty

ACTIVE COMPARATOR

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

Other: Reperfusion strategies

Interventions

Reperfusion strategies OTHER

Two different reperfusion strategies in STEMI will be compared: primary angioplasty vs. post-thrombolysis angioplasty

Post-thrombolysis angioplasty; Primary angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GRACIA Group: lead

Related Publications (3)

• 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.

  PMID: 15380963 BACKGROUND

• 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.

  PMID: 17244641 BACKGROUND

• 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.

  PMID: 20716757 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Francisco Fernandez-Aviles, MD, PhD

  faviles@secardiologia.es

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 20, 2014
• Study Start: May 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: March 1, 2016
• Last Updated: October 20, 2014

Record last verified: 2014-10