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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02268669
Recruitment Status : Unknown
Verified October 2014 by Pedro L Sanchez, GRACIA Group.
Recruitment status was:  Active, not recruiting
First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Pedro L Sanchez, GRACIA Group

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Other: Reperfusion strategies Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Primary PCI and Post-thrombolysis PCI as Reperfusion Strategies in Patients With ST Segment Elevation Acute Myocardial Infarction
Study Start Date : May 2010
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. Incidence of cardiovascular mortality [ Time Frame: 12 months ]
  6. Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage [ Time Frame: 30 days ]
  7. Incidence of major bleeding events [ Time Frame: Hospitalization and at 30 days ]
  8. 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 ]
  9. Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage [ Time Frame: 3 years ]
  10. Incidence of death [ Time Frame: 3 years ]
  11. Incidence of reinfarction [ Time Frame: 3 years ]
  12. Incidence of new revascularization [ Time Frame: 3 years ]
  13. Incidence of rehospitalization [ Time Frame: 3 years ]
  14. 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 ]
  15. 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 ]
  16. 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 ]
  17. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268669


Sponsors and Collaborators
GRACIA Group
Investigators
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Study Chair: Francisco Fernandez-Aviles, MD, PhD faviles@secardiologia.es

Publications:
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Responsible Party: Pedro L Sanchez, Coordinator, GRACIA Group
ClinicalTrials.gov Identifier: NCT02268669    
Other Study ID Numbers: GRACIA4
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: October 20, 2014
Last Verified: October 2014
Keywords provided by Pedro L Sanchez, GRACIA Group:
primary angioplasty
post-thrombolysis angioplasty
ST elevation acute myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases