Role of Tirofiban and the Paclitaxel Eluting Stent in Postfibrinolysis Angioplasty
NCT ID: NCT00306228
Last Updated: 2009-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
436 participants
INTERVENTIONAL
2004-10-31
2009-01-31
Brief Summary
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The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary stent-angioplasty of the culprit artery under the protection of tirofiban 120 minutes after fibrinolytic significantly improves epicardial and myocardial infusion in comparison with the strategy of performing immediate intravenous thrombolysis (tenecteplase plus enoxaparine) followed by coronary angiography and adequate revascularization.
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Detailed Description
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Methods: This is a phased 4, 2x2 randomised, open, multicenter, clinical study. Patients will be randomised 1:1:1:1 to four groups: a) paclitaxel eluting stent with tirofiban, b) paclitaxel eluting stent without tirofiban, c) bare stent with tirofiban and d) bare stent without tirofiban. A total of approximately 436 patients, with \<12 hours STEMI will be enrolled. All patients will be initially treated with tenecteplase (TNK) and enoxaparin. Tirofiban will start 120 minutes after tenecteplase administration in those patients randomised to tirofiban. Cardiac catheterization will be performed within the first 3-12 hours after the study inclusion and stenting on the culprit artery, with the randomised paclitaxel or bare stent, will be performed.
The efficacy of these strategies will be measured in terms of: 1) binary restenosis, defined as \>50% diameter stenosis and segment analysis including the stented segment as well as their margins, 5 mm proximal and distal to the stent at 9-12 months follow-up and, 2) the assessment of the epicardial and myocardial perfusion (%TIMI 3, CTFC, CFR-CTFC, TMP y DSA-TMP and the analysis of the normalization of the ST segment at 90 minutes, 3, 6, 12 and 24 hours after thrombolysis).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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bare-metal stent without tirofiban
implantation of a bare-metal stent with no tirofiban infusion after fibrinolysis
Postfibrinolysis percutaneous coronary intervention
implantation of a bare-metal stent with no infusion of tirofiban 120 minutes after fibrinolysis
bare-metal stent with tirofiban
implantation of a bare-metal stent with tirofiban infusion after fibrinolysis
Postfibrinolysis percutaneous coronary intervention
implantation of a bare-metal stent with infusion of tirofiban 120 minutes after fibrinolysis
paclitaxel-eluting stent without tirofiban
implantation of a paclitaxel eluting-stent with no tirofiban after fibrinolysis
Postfibrinolysis percutaneous coronary intervention
implantation of a paclitaxel eluting-stent with no infusion of tirofiban 120 minutes after fibrinolysis
paclitaxel-eluting stent with tirofiban
implantation of a paclitaxel eluting-stent with tirofiban infusion after fibrinolysis
Postfibrinolysis percutaneous coronary intervention
implantation of a paclitaxel eluting-stent with infusion of tirofiban 120 minutes after fibrinolysis
Interventions
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Postfibrinolysis percutaneous coronary intervention
implantation of a bare-metal stent with no infusion of tirofiban 120 minutes after fibrinolysis
Postfibrinolysis percutaneous coronary intervention
implantation of a bare-metal stent with infusion of tirofiban 120 minutes after fibrinolysis
Postfibrinolysis percutaneous coronary intervention
implantation of a paclitaxel eluting-stent with no infusion of tirofiban 120 minutes after fibrinolysis
Postfibrinolysis percutaneous coronary intervention
implantation of a paclitaxel eluting-stent with infusion of tirofiban 120 minutes after fibrinolysis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Age \>18 years.
2. Chest discomfort \>30 minutes with no response to nitroglycerin.
3. Time from the onset of symptoms to randomization \< 12 hours.
4. ST segment elevation \> 1 mm in two or more limb leads or 2 mm in two or more contiguous precordial leads or non-diagnostic ECG (left bundle branch block or pacemaker rhythm) with classic symptoms.
5. Killip class \> 3.
6. Written informed consent will be obtained.
Exclusion Criteria
1. Cardiogenic shock defined as a systolic blood pressure \<90 mm Hg without response to fluid administration or \<100 mmHg in patients with supportive treatment and no bradycardia.
2. Suspected mechanical complications of acute myocardial infarction.
3. Previous CABG.
4. Non-cardiac disease that is likely to jeopardize the planned termination of the study.
5. Woman of childbearing potential unless a negative pregnant test.
6. Active bleeding and recent (within 2 weeks) surgery that contraindicate the use of heparin, tirofiban, or platelet aggregation inhibitors.
7. Contraindications for thrombolytic use.
* previous hemorrhagic stroke at any time
* history of prior non-hemorrhagic cerebrovascular accident within 12 months
* intracerebral neoplasia
* active internal bleeding
* suspected aortic dissection
* Uncontrolled hypertension \>180/110 in several measurements
* any other known intracerebral pathology not covered in contraindications
* Current use of anticoagulants or heparin use within 8 hours
* known bleeding diathesis
* recent trauma (\< 4 weeks), including head trauma or traumatic or prolonged (\>10 minutes) CPR or recent major surgery or biopsy (\<8 weeks)
* noncompressible vascular punctures
* recent (\< 4 weeks) internal bleeding
* pregnancy
* active peptic ulcer
8. History of hypersensitivity to aspirin, ticlopidine, clopidogrel, heparin, tirofiban and stainless steel.
9. Known renal failure, creatinine \>2,5 mg/dL.
10. Known impaired hepatic function that contraindicates the use of clopidogrel.
11. Known thrombocytopenia (100.000).
12. Participation in other trial.
13. Known multivessel disease identified as no suitable for revascularization.
14. Known peripheral vascular disease that difficult cardiac catheterization.
18 Years
ALL
No
Sponsors
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Spanish Ministry of Health.
UNKNOWN
Ministry of Science and Innovation, Spain
OTHER_GOV
GRACIA Group
OTHER
Responsible Party
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Hospital General Universitario Gregorio Maranon
Principal Investigators
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Francisco Fernandez-Aviles, MD, PhD
Role: STUDY_CHAIR
ICICOR, Hospital Clínico Universitario Valladolid, Spain
Locations
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Instituto de Ciencias del Corazón (ICICOR). Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain
Countries
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References
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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.
Other Identifiers
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GRACIA 3
Identifier Type: -
Identifier Source: org_study_id
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