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Sponsored by: |
GRACIA Group |
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Information provided by: | GRACIA Group |
ClinicalTrials.gov Identifier: | NCT00306228 |
The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary angioplasty of the culprit artery with paclitaxel eluting stent significantly reduces the rate of restenosis in comparison with bare stents. 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.
Condition | Intervention | Phase |
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Myocardial Infarction |
Procedure: Postfibrinolysis percutaneous coronary intervention |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised Trial to Evaluate the Role of Paclitaxel Eluting Stent and Tirofiban to Improve the Results of Facilitated PCI in the Treatment of Acute ST- Segment Elevation Myocardial Infarction |
Estimated Enrollment: | 436 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | August 2007 |
The primary objectives of this study are: first to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis, and second to determine the effect of tirofiban administered prior to percutaneous coronary intervention (PCI) but 120 minutes after thrombolytic on the epicardial and myocardial flow after mechanical revascularization in patients with STEMI. 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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with ST-segment elevation acute myocardial infarction with all of the following criteria will be eligible for enrollment:
Exclusion Criteria:
Patients presenting with any of the following will not be included in the study.
Contraindications for thrombolytic use.
Contact: Margarita Rodriguez | Margarita.Rodriguez@chiltern.com |
Spain | |
Instituto de Ciencias del Corazón (ICICOR). Hospital Clínico Universitario de Valladolid | Recruiting |
Valladolid, Spain, 47005 | |
Contact: Pedro L Sanchez, MD; PhD 34-983-420026 pedrolsanchez@secardiologia.es | |
Principal Investigator: Pedro L Sanchez, MD, PhD |
Study Chair: | Francisco Fernandez-Aviles, MD, PhD | ICICOR, Hospital Clínico Universitario Valladolid, Spain |
Study ID Numbers: | GRACIA 3 |
Study First Received: | March 21, 2006 |
Last Updated: | March 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00306228 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
ST elevation acute myocardial infarction Thrombolysis Early routine percutaneous coronary intervention tirofiban paclitaxel |
Heart Diseases Myocardial Ischemia Tirofiban Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Ischemia Antimitotic Agents |
Fibrin Modulating Agents Necrosis Paclitaxel Tubulin Modulators Platelet Aggregation Inhibitors Infarction Myocardial Infarction Antineoplastic Agents, Phytogenic |
Heart Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myocardial Ischemia Tirofiban Hematologic Agents Mitosis Modulators Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Ischemia Antimitotic Agents |
Pharmacologic Actions Fibrin Modulating Agents Necrosis Pathologic Processes Paclitaxel Therapeutic Uses Tubulin Modulators Platelet Aggregation Inhibitors Cardiovascular Diseases Infarction Antineoplastic Agents, Phytogenic Myocardial Infarction |