Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
NCT ID:
NCT00433966
Group ID:
EG001
Title:
Pharmacology Arm - Unfractionated Heparin
Description:
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
Deaths Number Affected:
134
Deaths Number At Risk:
None
Serious Number Affected:
439
Serious Number At Risk:
1802
Other Number Affected:
132
Other Number At Risk:
1802
Study:
NCT00433966
Results Section:
NCT00433966
Adverse Events Module:
NCT00433966