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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
436
implantation of a bare-metal stent with no infusion of tirofiban 120 minutes after fibrinolysis
implantation of a bare-metal stent with infusion of tirofiban 120 minutes after fibrinolysis
implantation of a paclitaxel eluting-stent with no infusion of tirofiban 120 minutes after fibrinolysis
implantation of a paclitaxel eluting-stent with infusion of tirofiban 120 minutes after fibrinolysis
Instituto de Ciencias del Corazón (ICICOR). Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain
to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis
Time frame: 12 months
to determine the effect of tirofiban administered prior to PCI but 120 minutes after thrombolytic on the epicardial and myocardial flow after mechanical revascularization in patients with STEMI
Time frame: 24 hours
to determine the safety of paclitaxel eluting stent in terms of rate of complications, and particularly acute and subacute total occlusion.
Time frame: 12 months
to determine the interaction of paclitaxel eluting stent and the complicated myocardial infarction lesion in terms of reduction of intimal proliferation as evaluated by quantitative coronary angiography
Time frame: 12 months
to determine the efficacy of paclitaxel eluting stent in different subgroups of patients: diabetics, small vessel (<2.5 mm), long lesion (>15 mm), gender, and tirofiban use.
Time frame: 12 months
to determine the efficacy and safety of full dose fibrinolytic therapy plus delayed tirofiban compared to fibrinolytic therapy alone in different subgroups: diabetics and the elderly
Time frame: 30 days
to determine the efficacy of use of tirofiban in relation to time to fibrinolytic therapy and time to mechanical revascularization.
Time frame: 24 hours
to determine possible interactions between the paclitaxel eluting stent and tirofiban in terms of restenosis or acute and subacute total occlusion following coronary stenting.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.