Clinical Trial: Abciximab in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Routine Upfront Abciximab Versus Standard Peri-Procedural Therapy in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock PRAGUE-7 Trial.
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) IIb/IIIa 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 IIb/IIIa 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 Summary:
Routine upfront abciximab versus standard peri-procedural therapy in patients undergoing percutaneous coronary intervention for cardiogenic shock PRAGUE-7 Trial.
Hypothesis:
GP IIb/IIIa 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" (i.e. 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 70IU/kg of body weigh Abciximab bolus 0,25 mg/kg of body weigh
Sponsor: Charles University, Czech Republic
Current Primary Outcome: Combined end-point death/reinfarction/stroke/TIMI-flow <3/EF <30% on day 30. [ Time Frame: 30 days ]
Original Primary Outcome: Combined end-point death/reinfarction/stroke/TIMI-flow <3/EF <30% on day 30.
Current Secondary Outcome:
- Left ventricular EF assessed by echocardiography on the day 30 (in deceased pts. EF assumed to be 0%) [ Time Frame: 30 days ]
- Rate of major bleeding complication [ Time Frame: 30 days ]
- Myocardial blush score after PCI [ Time Frame: immediately after PCI ]
- TIMI-flow after PCI [ Time Frame: immediatelly after PCI ]
Original Secondary Outcome:
- Left ventricular EF assessed by echocardiography on the day 30 (in deceased pts. EF assumed to be 0%)
- Rate of major bleeding complication
- Myocardial blush score after PCI
- TIMI-flow after PCI
Information By: Charles University, Czech Republic
Dates:
Date Received: January 8, 2007
Date Started: September 2006
Date Completion:
Last Updated: June 22, 2009
Last Verified: June 2009
