Ignite Creation Date:
2024-05-06 @ 3:01 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02182011
Status:
COMPLETED
Last Update Posted:
2014-07-14
First Post:
2014-07-02
Brief Title:
A Study to Investigate the Procoagulant Effect of Tenecteplase TNK-tPA Alteplase Rt-PA and Streptokinase SK Administered to Patients With Acute Myocardial Infarction AMI
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open-label Randomised Parallel-group Comparison to Investigate the Procoagulant Effect of Tenecteplase TNK-tPA Alteplase Rt-PA and Streptokinase SK Administered to Patients With AMI
Status:
COMPLETED
Status Verified Date:
2014-07
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:
Primary objective to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and streptokinase administered to patients with AMI by measuring the concentration of TAT at 2 hours after the start of treatment versus baseline values
Secondary objective change from baseline in concentration of TAT at 6 and 24 hours change from baseline in concentration of D-dimers F12 PAI-1 PAP at 2 6 and 24 hours Incidence of adverse events AEs in -hospital complications major or minor bleedings and serious adverse events
Secondary objective change from baseline in concentration of TAT at 6 and 24 hours change from baseline in concentration of D-dimers F12 PAI-1 PAP at 2 6 and 24 hours Incidence of adverse events AEs in -hospital complications major or minor bleedings and serious adverse events
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