Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046228
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2002-09-24
Brief Title:
A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction Finesse
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Muticenter Randomized Double-blind Placebo Controlled Trial Comparing the Efficacy and Safety of Reteplease and Abciximab Combination Therapy With Abciximab Alone Administered Early or Just Prior to Primary Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction
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:
The purpose of this study is to determine whether abciximab given in combination with reteplase before patients have a coronary intervention a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention
Detailed Description:
The purpose of this medical research study is to determine whether abciximab given in combination with reteplase before patients have a coronary intervention a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention This medical research study will also help determine if the combination of abciximab and reduced dose reteplase will decrease the risk of death and reduce complications of a heart attack at 90 days compared to abciximab alone which is a standard treatment
Patients will receive either abciximab and reteplease or abciximab alone Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests vital signs such as blood pressure physical examinations and the occurrence and severity of adverse events as well as other study specific procedures Patients will receive either abciximab and reteplease or abciximab and placebo into a vein in their arm for up to 12 hours
Patients will receive either abciximab and reteplease or abciximab alone Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests vital signs such as blood pressure physical examinations and the occurrence and severity of adverse events as well as other study specific procedures Patients will receive either abciximab and reteplease or abciximab and placebo into a vein in their arm for up to 12 hours
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 |
|---|---|---|---|
| CR005410 | None | None | None |
| FINESSE | None | None | None |