Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306228
Status:
COMPLETED
Last Update Posted:
2009-09-28
First Post:
2006-03-21
Brief Title:
Role of Tirofiban and the Paclitaxel Eluting Stent in Postfibrinolysis Angioplasty
Sponsor:
GRACIA Group
Organization:
GRACIA Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRACIA3
Brief Summary:
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 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
Detailed Description:
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 1111 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
Methods This is a phased 4 2x2 randomised open multicenter clinical study Patients will be randomised 1111 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None