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

University Hospital, Motol

Status and phase: Unknown; Phase 3

Conditions: Coronary Artery Disease; Coronary Angioplasty

Treatments: Drug: atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01058057

KC EK-150/08

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) 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.

Full 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)

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Atorvastatin

Experimental group

Description:

Atorvastatin 80mg seven days pre-treatment before PCI

Treatment:

Drug: atorvastatin