Ignite Creation Date:
2024-05-06 @ 1:38 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01863134
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2013-05-18
Brief Title:
Clinical Effects of Eptifibatide Administration in High Risk Patients Presenting With Non-ST Segment Elevation Acute Coronary Syndrome NSTE-ACS Requiring Urgent Coronary Artery Bypass Graft Surgery in Short- and Long-Term Follow-up
Sponsor:
Medical University of Silesia
Organization:
Medical University of Silesia
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-08
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:
None
Brief Summary:
1 INTRODUCTION
Through last couple of years the number of patients treated for acute coronary event without persistent ST segment elevation in ECG has been growing
This is probably an effect of improving diagnostics of myocardial infraction without persistent ST segment elevation in ECG due to routine Troponin serum level evaluation and better primary prevention
This fact makes the search for the optimal treatment for patients with acute coronary event without persistent ST segment elevation in ECG including both patients intended for pharmacological and invasive treatment percutaneous coronary intervention PCI or coronary artery byppass grafting CABG
Patients undergoing invasive treatment for acute coronary event have higher risk rate than those with stabile angina pectoris
The authors of this study want to evaluate whether the proportional use of platelet GP IIbIIIa receptor antagonist - eptifibatide in patients undergoing CABG results in improvement of short- and long time results in those patients
Eptifibatide Integrilin a cyclic heptapeptide antagonist of the GP IIbIIIa integrin receptor is an intravenous antagonist with rapid onset and short half-life
2 STUDY RATIONALE
The notion acute coronary syndrome ACS includes several clinical situations such a unstable coronary artery disease non-Q wave myocardial infarction and Q wave myocardial infarction
On the basis of 12-lead ECG patients with acute coronary syndrome ACS can be divided into two groups with and without ST segment elevation
Another stratification factor in patients with ACS especially these without ST elevation is evaluation of biochemical markers of myocardial necrosis such as Troponins TnI TnT and creatinine kinase isoenzymes CK-MB Serum concentrations of these markers allow to distinguish myocardial infarction elevation of markers concentration from unstable coronary artery disease
All ACS have common etiopathogenesis which is plaque rupture thrombus formation in the lumen of coronary artery
Platelets are the key factor in this process Platelets by means of their collagen and von Willebrand factor glycoprotein receptors bind to damaged artery wall Simultaneously many factors cause platelet activation which leads to changes in their shape release of intraplatelet components and activation of fibrinogen-binding glycoprotein receptors IIbIIIa GP IIbIIIa Activated form of GP IIbIIIa binds to GP IIbIIIa of another platelet by means of fibrinogen molecule Fibrinogen molecules form stable bridges between platelets This process is referred to as aggregation and leads to clot formation which is further stabilized by fibrine fibres
In this way the intravascular thrombus is formed which after totally occluding the arterial lumen causes acute ischemia of the relevant region of myocardium and subsequently its infarction
The key role of GP IIaIIIb in the process of platelet clot formation has important therapeutic consequences By now several specific direct and non-specific indirect antagonists of GP IIbIIIa have been developed
There are indirect antagonists as acetylsalicylic acid ticlopidine and clopidogrel and direct antagonists as abciximab tirofiban and eptifibatide Additionally also anticoagulants heparin LMWH - low molecular weight heparin have antiplatelet properties by inhibiting thrombin production
Clinical studies performed all over the world have proven the efficacy and safety of three agents from the GP IiaIIIb group abciximab tirofiban and eptifibatide
In several big clinical studies EPIC EPILOG EPISTENT ESPRIT CAPTURE PURSUIT PRISM-PLUS TACTICS-TIMI 18 the high efficacy of these drugs was showed in patients with ACS without ST segment elevation undergoing mainly percutaneous transluminal coronary angiography PTCA and stenting The use of GP IIaIIIb antagonists in this group of patients significantly reduces the death and myocardial infarction MI rate during early as well as late follow-up period Moreover last observations indicate that the biggest benefit from such therapeutic strategy is observed in high risk patients those with diabetes high troponin levels and ECG changes
During last years there is an increase in frequency of ACS without ST segment elevation This is probably due to improved diagnostics of MI without ST elevation basing on routine troponin evaluation but also thanks to better primary prevention
Therefore determining an optimal therapeutic strategy for patients with ACS without ST segment elevation remains a crucial issue
It concerns patients qualified to medical treatment as well as those qualified to invasive procedures PTCA or CABG
Through last couple of years the number of patients treated for acute coronary event without persistent ST segment elevation in ECG has been growing
This is probably an effect of improving diagnostics of myocardial infraction without persistent ST segment elevation in ECG due to routine Troponin serum level evaluation and better primary prevention
This fact makes the search for the optimal treatment for patients with acute coronary event without persistent ST segment elevation in ECG including both patients intended for pharmacological and invasive treatment percutaneous coronary intervention PCI or coronary artery byppass grafting CABG
Patients undergoing invasive treatment for acute coronary event have higher risk rate than those with stabile angina pectoris
The authors of this study want to evaluate whether the proportional use of platelet GP IIbIIIa receptor antagonist - eptifibatide in patients undergoing CABG results in improvement of short- and long time results in those patients
Eptifibatide Integrilin a cyclic heptapeptide antagonist of the GP IIbIIIa integrin receptor is an intravenous antagonist with rapid onset and short half-life
2 STUDY RATIONALE
The notion acute coronary syndrome ACS includes several clinical situations such a unstable coronary artery disease non-Q wave myocardial infarction and Q wave myocardial infarction
On the basis of 12-lead ECG patients with acute coronary syndrome ACS can be divided into two groups with and without ST segment elevation
Another stratification factor in patients with ACS especially these without ST elevation is evaluation of biochemical markers of myocardial necrosis such as Troponins TnI TnT and creatinine kinase isoenzymes CK-MB Serum concentrations of these markers allow to distinguish myocardial infarction elevation of markers concentration from unstable coronary artery disease
All ACS have common etiopathogenesis which is plaque rupture thrombus formation in the lumen of coronary artery
Platelets are the key factor in this process Platelets by means of their collagen and von Willebrand factor glycoprotein receptors bind to damaged artery wall Simultaneously many factors cause platelet activation which leads to changes in their shape release of intraplatelet components and activation of fibrinogen-binding glycoprotein receptors IIbIIIa GP IIbIIIa Activated form of GP IIbIIIa binds to GP IIbIIIa of another platelet by means of fibrinogen molecule Fibrinogen molecules form stable bridges between platelets This process is referred to as aggregation and leads to clot formation which is further stabilized by fibrine fibres
In this way the intravascular thrombus is formed which after totally occluding the arterial lumen causes acute ischemia of the relevant region of myocardium and subsequently its infarction
The key role of GP IIaIIIb in the process of platelet clot formation has important therapeutic consequences By now several specific direct and non-specific indirect antagonists of GP IIbIIIa have been developed
There are indirect antagonists as acetylsalicylic acid ticlopidine and clopidogrel and direct antagonists as abciximab tirofiban and eptifibatide Additionally also anticoagulants heparin LMWH - low molecular weight heparin have antiplatelet properties by inhibiting thrombin production
Clinical studies performed all over the world have proven the efficacy and safety of three agents from the GP IiaIIIb group abciximab tirofiban and eptifibatide
In several big clinical studies EPIC EPILOG EPISTENT ESPRIT CAPTURE PURSUIT PRISM-PLUS TACTICS-TIMI 18 the high efficacy of these drugs was showed in patients with ACS without ST segment elevation undergoing mainly percutaneous transluminal coronary angiography PTCA and stenting The use of GP IIaIIIb antagonists in this group of patients significantly reduces the death and myocardial infarction MI rate during early as well as late follow-up period Moreover last observations indicate that the biggest benefit from such therapeutic strategy is observed in high risk patients those with diabetes high troponin levels and ECG changes
During last years there is an increase in frequency of ACS without ST segment elevation This is probably due to improved diagnostics of MI without ST elevation basing on routine troponin evaluation but also thanks to better primary prevention
Therefore determining an optimal therapeutic strategy for patients with ACS without ST segment elevation remains a crucial issue
It concerns patients qualified to medical treatment as well as those qualified to invasive procedures PTCA or CABG
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