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Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2

Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01058057
Acronym
TIPS-2
Enrollment
200
Registered
2010-01-28
Start date
2008-02-29
Completion date
Unknown
Last updated
2010-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Angioplasty, Coronary Artery Disease

Keywords

atorvastatin, percutaneous coronary intervention, periprocedural myocardial infarction, Hydroxymethylglutaryl-CoA Reductase Inhibitors

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)

Interventions

DRUGatorvastatin

atorvastatin 80mg p.o. daily seven days before PCI

Sponsors

University Hospital, Motol
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Indication for percutaneous coronary intervention * Informed consent * Chronic statin therapy

Exclusion criteria

* Acute coronary syndrome in last 14 days * Renal insufficiency (creatinine more 150 umol/l) * Diseases severely limiting prognosis * Previous participation in this study * Chronic occlusion of the coronary artery, bypass intervention, left main intervention * Chronic statin treatment with atorvastatin 80mg daily and rosuvastatin

Design outcomes

Primary

MeasureTime frame
periprocedural myocardial infarction measured by troponin I level24 hours after PCI

Secondary

MeasureTime frame
periprocedural myocardial infarction measured by creatinine kinase myocardial band24 hours after PCI

Countries

Czechia

Contacts

Primary ContactDavid Zemanek, MD
zejada@seznam.cz+420608921

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026