Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-28 @ 6:30 PM
Study NCT ID:
NCT01058057
Status:
UNKNOWN
Last Update Posted:
2010-02-03
First Post:
2010-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2
Sponsor:
University Hospital, Motol
Organization:
Study Overview
Official Title:
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2
Status:
UNKNOWN
Status Verified Date:
2008-01
Last Known Status:
RECRUITING
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:
TIPS-2
Brief Summary:
This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) on chronic statin therapy. Patients are randomized into two groups: atorvastatin pre-treatment group (80mg atorvastatin seven days before PCI) and control group (PCI without atorvastatin pretreatment, chronic statin treatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.
Detailed Description:
This randomized study investigates potential protective effect of high dose atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) and chronic statin therapy.
Two arms:
1. atorvastatin pre-treatment group (80mg atorvastatin for seven days)
2. control group (without atorvastatin pre-treatment, chronic statin treatment)
Primary endpoint:
Periprocedural myocardial infarction measured by troponin I level (time frame 24 hours)
Secondary endpoint:
Periprocedural myocardial infarction measured by creatine kinase myocardial band (time frame 24 hours)
Two arms:
1. atorvastatin pre-treatment group (80mg atorvastatin for seven days)
2. control group (without atorvastatin pre-treatment, chronic statin treatment)
Primary endpoint:
Periprocedural myocardial infarction measured by troponin I level (time frame 24 hours)
Secondary endpoint:
Periprocedural myocardial infarction measured by creatine kinase myocardial band (time frame 24 hours)
Study Oversight
Has Oversight DMC:
False
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?: