Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420030
Status:
COMPLETED
Last Update Posted:
2009-06-23
First Post:
2007-01-08
Brief Title:
Abciximab in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock
Sponsor:
Charles University Czech Republic
Organization:
Charles University Czech Republic
Study Overview
Official Title:
Routine Upfront Abciximab Versus Standard Peri-Procedural Therapy in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock PRAGUE-7 Trial
Status:
COMPLETED
Status Verified Date:
2009-06
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:
Outcome of patients with myocardial infarction complicated with cardiogenic shock is very poor Although early mechanical revascularization has been demonstrated superior to conservative medical treatment mortality range remains about 45-60 Some medical registries have showed further therapeutic benefit by administration of glycoprotein GP IIbIIIa inhibitors during PCI in patients with cardiogenic shock However there is no randomized study that supports this therapeutic strategy in these high risk patients
Hypothesis
GP IIbIIIa inhibitors improve angiographic TIMI-flow echocardiographic LV function and clinical combined end-point outcomes in patients with myocardial infarction complicated with cardiogenic shock
Study design
Open pseudorandomized multicenter phase IV clinical trial
Anticipated findings
The investigators anticipate to document better angiographic echocardiographic and clinical outcome after upfront abciximab administration in comparison to standard periprocedural therapy in patients undergoing PCI for cardiogenic shock This would be the first randomized clinical trial that could support this therapeutic strategy
Hypothesis
GP IIbIIIa inhibitors improve angiographic TIMI-flow echocardiographic LV function and clinical combined end-point outcomes in patients with myocardial infarction complicated with cardiogenic shock
Study design
Open pseudorandomized multicenter phase IV clinical trial
Anticipated findings
The investigators anticipate to document better angiographic echocardiographic and clinical outcome after upfront abciximab administration in comparison to standard periprocedural therapy in patients undergoing PCI for cardiogenic shock This would be the first randomized clinical trial that could support this therapeutic strategy
Detailed Description:
Routine upfront abciximab versus standard peri-procedural therapy in patients undergoing percutaneous coronary intervention for cardiogenic shock PRAGUE-7 Trial
Hypothesis
GP IIbIIIa inhibitors improve angiographic TIMI-flow echocardiographic LV function and clinical combined end-point outcomes in patients with myocardial infarction complicated with cardiogenic shock
Study design
Open pseudorandomized multicenter phase IV clinical trial The reason for pseudorandomization ie randomization by even or odd date when the PCI is performed is ethical it saves time what is critical in this clinical setting It does not delay treatment at all while classical randomization in cardiogenic shock may sometimes delay treatment by up to 15 minutes and this is the main reason why randomized trials on shock are rarely able to enroll patients
Groups
Group A - Upfront administration of abciximab bolus followed by 12-hours abciximab infusion standard therapy Group B - Standard peri-procedural therapy with possibility of abciximab administration according the interventional cardiologist Expected rate of peri-procedural abciximab administration in this group is 20 of patients
Allowed and excluded concomitant medication see bellow in the table
Group A Group B
Before PCI Aspirin according to physician All treatment according to Clopidogrel according to physician physician Heparin bolus 70IUkg of body weigh Abciximab bolus 025 mgkg of body weigh
During PCI Abciximab 12-hours infusion 0125microgramkgmin Abciximab according to Other treatment according to physician physician
Excluded Thrombolysis Eptifibatide Tirofiban Thrombolysis Eptifibatide treatment Tirofiban
Proposed sample size
80 patients 40 patients in each group This number of patient permit to complete the study within 2 years Because of this and because of incidence of cardiogenic shock the study sample size is not supported statistically
Objectives
Primary Thirty-day clinical combined outcome death reinfarction stroke new renal failure
Death death from any cause reinfarction recurrent ischemic symptoms with new increase in CK-MB stroke any new neurologic deficit lasting 24 hours new renal failure increase in creatinine to 300 micromoll
Secondary 1 Combined end-point death reinfarction stroke TIMI-flow 3 EF 30 on day 30 2 Left ventricular EF assessed by echocardiography on the day 30 in deceased pts EF assumed to be 0 3 Rate of major bleeding complication 4 Myocardial blush score after PCI 5 TIMI-flow after PCI
Statistical analysis
Thirty-day clinical outcome as well as other categorical characteristics of patients in the two groups will be compared by Fishers exact test Group differences in continuous factors will be compared by by Studentt-test and the Wilcoxon rank-sum test
Cardiac catheterization PCI and abciximab
Patients in both groups will undergo coronary angiography by femoral access using 5F or 6F sheath and catheters All patients will receive standard antithrombotic and anticoagulant treatment either during transport or directly at the catheterization laboratory Patients randomized into group A will receive bolus of abciximab given as a bolus dose of 025mg per kg of body weight immediately after randomization either in CCU emergency dept or upon arrival to cath-lab followed by an infusion of 0125microgramkgmin maximum 10microgrammin for 12 hours
PCI - will be performed immediately after coronary angiography if technically feasible PCI will be performed at infarct related artery IRA Intracoronary stent - will be implanted if possible Type length and size of the stent will be choose according decision of invasive cardiologist
Abciximab - will be given to all patients randomized into group A as mentioned above Periprocedural abciximab bolus 025mgkg followed by 12-hours abciximab infusion 0250 microgramkgmin will be given selectively to patients randomized into group B according to the decision of invasive cardiologist - we expect that GPIIbIIIa inhibitor abciximab will be given to cca 10-20 of patients in this group what is our current routine for the use of GPIIbIIIa blockers in this setting
Angiographic data will be stored on CD Independent invasive cardiologist blind to clinical data and blind to the randomization of the patient will assess TIMI flow of IRA before and after PCI grade 0-3 myocardial blush score before and after PCI in the area of IRA grade 0-3 and TIMI frame count after PCI
Echocardiography
Complete echocardiographic examination will be performed 24hours on the day 7 and day 30 after PCI Vivid7 ultrasound systems will be used Data will be stored in digital form if possible otherwise storage on S-VHS will be used Independent observer will assess
end-systolic and enddiastolic diameter of left ventricle parasternal view
ejection fraction measured using Simsons method
regional left ventricle function
Ethical consideration
The approval of local ethical committee is required as for any other research protocol
Anticipated finding
We anticipate to document better angiographic echocardiographic and clinical outcome after upfront abciximab administration in comparison to standard periprocedural therapy in patients undergoing PCI for cardiogenic shock This would be the first randomized clinical trial that could support this therapeutic strategy
Hypothesis
GP IIbIIIa inhibitors improve angiographic TIMI-flow echocardiographic LV function and clinical combined end-point outcomes in patients with myocardial infarction complicated with cardiogenic shock
Study design
Open pseudorandomized multicenter phase IV clinical trial The reason for pseudorandomization ie randomization by even or odd date when the PCI is performed is ethical it saves time what is critical in this clinical setting It does not delay treatment at all while classical randomization in cardiogenic shock may sometimes delay treatment by up to 15 minutes and this is the main reason why randomized trials on shock are rarely able to enroll patients
Groups
Group A - Upfront administration of abciximab bolus followed by 12-hours abciximab infusion standard therapy Group B - Standard peri-procedural therapy with possibility of abciximab administration according the interventional cardiologist Expected rate of peri-procedural abciximab administration in this group is 20 of patients
Allowed and excluded concomitant medication see bellow in the table
Group A Group B
Before PCI Aspirin according to physician All treatment according to Clopidogrel according to physician physician Heparin bolus 70IUkg of body weigh Abciximab bolus 025 mgkg of body weigh
During PCI Abciximab 12-hours infusion 0125microgramkgmin Abciximab according to Other treatment according to physician physician
Excluded Thrombolysis Eptifibatide Tirofiban Thrombolysis Eptifibatide treatment Tirofiban
Proposed sample size
80 patients 40 patients in each group This number of patient permit to complete the study within 2 years Because of this and because of incidence of cardiogenic shock the study sample size is not supported statistically
Objectives
Primary Thirty-day clinical combined outcome death reinfarction stroke new renal failure
Death death from any cause reinfarction recurrent ischemic symptoms with new increase in CK-MB stroke any new neurologic deficit lasting 24 hours new renal failure increase in creatinine to 300 micromoll
Secondary 1 Combined end-point death reinfarction stroke TIMI-flow 3 EF 30 on day 30 2 Left ventricular EF assessed by echocardiography on the day 30 in deceased pts EF assumed to be 0 3 Rate of major bleeding complication 4 Myocardial blush score after PCI 5 TIMI-flow after PCI
Statistical analysis
Thirty-day clinical outcome as well as other categorical characteristics of patients in the two groups will be compared by Fishers exact test Group differences in continuous factors will be compared by by Studentt-test and the Wilcoxon rank-sum test
Cardiac catheterization PCI and abciximab
Patients in both groups will undergo coronary angiography by femoral access using 5F or 6F sheath and catheters All patients will receive standard antithrombotic and anticoagulant treatment either during transport or directly at the catheterization laboratory Patients randomized into group A will receive bolus of abciximab given as a bolus dose of 025mg per kg of body weight immediately after randomization either in CCU emergency dept or upon arrival to cath-lab followed by an infusion of 0125microgramkgmin maximum 10microgrammin for 12 hours
PCI - will be performed immediately after coronary angiography if technically feasible PCI will be performed at infarct related artery IRA Intracoronary stent - will be implanted if possible Type length and size of the stent will be choose according decision of invasive cardiologist
Abciximab - will be given to all patients randomized into group A as mentioned above Periprocedural abciximab bolus 025mgkg followed by 12-hours abciximab infusion 0250 microgramkgmin will be given selectively to patients randomized into group B according to the decision of invasive cardiologist - we expect that GPIIbIIIa inhibitor abciximab will be given to cca 10-20 of patients in this group what is our current routine for the use of GPIIbIIIa blockers in this setting
Angiographic data will be stored on CD Independent invasive cardiologist blind to clinical data and blind to the randomization of the patient will assess TIMI flow of IRA before and after PCI grade 0-3 myocardial blush score before and after PCI in the area of IRA grade 0-3 and TIMI frame count after PCI
Echocardiography
Complete echocardiographic examination will be performed 24hours on the day 7 and day 30 after PCI Vivid7 ultrasound systems will be used Data will be stored in digital form if possible otherwise storage on S-VHS will be used Independent observer will assess
end-systolic and enddiastolic diameter of left ventricle parasternal view
ejection fraction measured using Simsons method
regional left ventricle function
Ethical consideration
The approval of local ethical committee is required as for any other research protocol
Anticipated finding
We anticipate to document better angiographic echocardiographic and clinical outcome after upfront abciximab administration in comparison to standard periprocedural therapy in patients undergoing PCI for cardiogenic shock This would be the first randomized clinical trial that could support this therapeutic strategy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSM 0021620817 | None | None | None |