Ignite Creation Date:
2024-05-06 @ 12:22 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01555658
Status:
UNKNOWN
Last Update Posted:
2012-03-15
First Post:
2012-03-06
Brief Title:
Bivalirudin Plus Stenting in Long Lesion to Avoid Periprocedural Myocardial Necrosis Trial
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Bivalirudin Plus Stenting in Long Lesion to Avoid Periprocedural Myocardial Necrosis Trial
Status:
UNKNOWN
Status Verified Date:
2012-03
Last Known Status:
NOT_YET_RECRUITING
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:
BILLION
Brief Summary:
Background
Randomized trials show improved outcomes among acute coronary syndrome ACS patients treated with Bivalirudin1 Optimal antithrombotic treatment in patients undergoing percutaneous coronary intervention PCI is crucial to balance the risk of post-PCI bleeding versus ischemic complications2 Bivalirudin a direct thrombin inhibitor has been extensively investigated as an intra-procedural antithrombotic therapy in patients with stable angina Non ST-segment elevation acute coronary syndrome NSTE-ACS and ST-segment elevation myocardial infarction STEMI Bivalirudin when used with or without glycoprotein IIbIIIa inhibitors GPI during PCI has been found to be superior to Unfractionated heparin UFH with or without GPI in reducing 30-day bleeding complications without significant increase in the rate of ischemic events3-5
Moreoverafter otherwise successful PCIan increase in cardiac biomarkers has been shown to occur in 5 to 30 of patients6 Recent studies have focused their attention onthe reduction of infarct size and the incidence of periprocedural type IVa myocardial infarction PMIafter elective PCI7-8 Therefore we will perform a single-center prospective and randomized study to assess if Bivalirudin versus UFHis effective in preventing elevation of biomarkers of MI after coronary stent implantation in patients already treated with aspirin and clopidogrelwith anatomically complex lesion
Objective
to assess the safety and efficacy of routine usage of the Bivalirudin vs UFH in patients with coronary artery disease CAD after stent implantation in coronary long lesions to avoid periprocedural myocardial necrosis
Setting
Single-center spontaneous prospective randomized 11 study of Bivalirudin infusion vs UFH in the setting of CAD after PCI with stenting incoronary long lesions
Comparison Bivalirudin vs UFH in preventing elevation of biomarkers of MI after coronary stent implantation in patients already treated with aspirin and clopidogrel with anatomically complex lesion
PopulationPatients with diffuse CAD undergoing percutaneous treatment on a native coronary vessel with planned implantation stents in overlapping with a total stent length 33 mm for long coronary lesions in vessels with a reference vessel diameter 225-40 mm
Assessment Following the procedure blood samples for CK CK-MB and Troponin will be collected at 612 and 24 h post PCI CK-MB values will be considered abnormal if they will elevate above the upper limit of normal ULN This is set at 6 mgL by our local laboratory If the first blood sample showed a CK-MB level 18 mgL 3 times upper normal limit a second blood sample would be drawn every 8 h later until a downward trend will be observed For patients with two or more blood samples drawn the peak CK-MB level will be used for analysis
End-points
The primary end-point of this study will be the incidence of periprocedural myonecrosis that was defined as a peak post-procedural CK-MB elevation 1 time the upper limit of normal ULN alone or associated with chest pain or ST-segment or T-wave abnormalities in patients undergoing non-urgent PCI
Secondary end-points will be the rate of MACCE major adverse cerebro-cardiovascular events ie the composite of death myocardial infarction defined according to the Academic Research Consortium statement target vessel revascularization or stroke the rate of major bleedings Bleeding Academic Consortium BARC 3-5 minor bleedings BARC 2 and the rate of NACE net adverse clinical events ie the composite of MACCE and major bleedings at 30 days 6 and 12 month follow-up Adverse events will be determined by telephone interview andor medical record review Clinical follow-up telephone-based interviews and office-based direct visits will be performed at 1 6 and 12 months respectively for end-point adjudication
Sample size and statistical analysis Given an expected rate of abnormal post-procedural peak CK-MB 1 x ULM of 48 based on results of the INSTANT trial for the control group and 29 for the experimental group thus a 40 relative risk reduction aiming for a 005 alpha and 080 power a total of 204 patients will need to be enrolled 102 patients per group
Randomized trials show improved outcomes among acute coronary syndrome ACS patients treated with Bivalirudin1 Optimal antithrombotic treatment in patients undergoing percutaneous coronary intervention PCI is crucial to balance the risk of post-PCI bleeding versus ischemic complications2 Bivalirudin a direct thrombin inhibitor has been extensively investigated as an intra-procedural antithrombotic therapy in patients with stable angina Non ST-segment elevation acute coronary syndrome NSTE-ACS and ST-segment elevation myocardial infarction STEMI Bivalirudin when used with or without glycoprotein IIbIIIa inhibitors GPI during PCI has been found to be superior to Unfractionated heparin UFH with or without GPI in reducing 30-day bleeding complications without significant increase in the rate of ischemic events3-5
Moreoverafter otherwise successful PCIan increase in cardiac biomarkers has been shown to occur in 5 to 30 of patients6 Recent studies have focused their attention onthe reduction of infarct size and the incidence of periprocedural type IVa myocardial infarction PMIafter elective PCI7-8 Therefore we will perform a single-center prospective and randomized study to assess if Bivalirudin versus UFHis effective in preventing elevation of biomarkers of MI after coronary stent implantation in patients already treated with aspirin and clopidogrelwith anatomically complex lesion
Objective
to assess the safety and efficacy of routine usage of the Bivalirudin vs UFH in patients with coronary artery disease CAD after stent implantation in coronary long lesions to avoid periprocedural myocardial necrosis
Setting
Single-center spontaneous prospective randomized 11 study of Bivalirudin infusion vs UFH in the setting of CAD after PCI with stenting incoronary long lesions
Comparison Bivalirudin vs UFH in preventing elevation of biomarkers of MI after coronary stent implantation in patients already treated with aspirin and clopidogrel with anatomically complex lesion
PopulationPatients with diffuse CAD undergoing percutaneous treatment on a native coronary vessel with planned implantation stents in overlapping with a total stent length 33 mm for long coronary lesions in vessels with a reference vessel diameter 225-40 mm
Assessment Following the procedure blood samples for CK CK-MB and Troponin will be collected at 612 and 24 h post PCI CK-MB values will be considered abnormal if they will elevate above the upper limit of normal ULN This is set at 6 mgL by our local laboratory If the first blood sample showed a CK-MB level 18 mgL 3 times upper normal limit a second blood sample would be drawn every 8 h later until a downward trend will be observed For patients with two or more blood samples drawn the peak CK-MB level will be used for analysis
End-points
The primary end-point of this study will be the incidence of periprocedural myonecrosis that was defined as a peak post-procedural CK-MB elevation 1 time the upper limit of normal ULN alone or associated with chest pain or ST-segment or T-wave abnormalities in patients undergoing non-urgent PCI
Secondary end-points will be the rate of MACCE major adverse cerebro-cardiovascular events ie the composite of death myocardial infarction defined according to the Academic Research Consortium statement target vessel revascularization or stroke the rate of major bleedings Bleeding Academic Consortium BARC 3-5 minor bleedings BARC 2 and the rate of NACE net adverse clinical events ie the composite of MACCE and major bleedings at 30 days 6 and 12 month follow-up Adverse events will be determined by telephone interview andor medical record review Clinical follow-up telephone-based interviews and office-based direct visits will be performed at 1 6 and 12 months respectively for end-point adjudication
Sample size and statistical analysis Given an expected rate of abnormal post-procedural peak CK-MB 1 x ULM of 48 based on results of the INSTANT trial for the control group and 29 for the experimental group thus a 40 relative risk reduction aiming for a 005 alpha and 080 power a total of 204 patients will need to be enrolled 102 patients per group
Detailed Description:
None
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