Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study (TIPS)

University Hospital, Motol

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00469326

KC EK-361/05

Details and patient eligibility

About

This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI). Patient are randomized to two groups: atorvastatin pre-treatment group (80mg atorvastatin two days before PCI) and control group (PCI without atorvastatin pretreatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.

Full description

Randomized studies have shown that pre-treatment with atorvastatin may reduced periprocedural myocardial in patient with stable angina during elective PCI. These data provide evidence-based support for using atorvastatin 7 days before PCI (dosage 40mg/d), alternatively three or more days (unknown dosage). We want to confirm this results for shorter pre-treatment period (two days) with dosage 80mg per day.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• stable angina in last month
• indication for percutaneous coronary intervention
• informed consent

Exclusion criteria

• acute coronary syndrome in last 14 days
• renal insufficiency (creatinine more 150 µmol/l)
• diseases severely limiting prognosis
• immunosuppressive treatment
• statin one month before randomization
• occlusion of the coronary artery
• previous participation in this study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

atorvastatin

Active Comparator group

Description:

atorvastatin pre-treatment group (80mg atorvastatin two days before PCI)

Treatment:

Drug: Atorvastatin

control

No Intervention group

Description:

PCI without atorvastatin pretreatment

Treatment:

Drug: Atorvastatin