Effective Dose of Statin Post PCI

Study Overview
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Brief Summary
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In this study post coronary stenting patients, were enrolled to receive moderate dose versus high dose statin for 1 year, and the result of major adverse cardiovascular events were recorded

Detailed Description
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In this randomized double-blind clinical trial, the study population was all patients with a recent history of PCI who referred to the professor kojuri cardiovascular clinic for the first post-procedure visit. In the first visit, patients were randomly divided into two groups Both groups were treated with Rosuvastatin 40 mg as high potency statin for one month after PCI. In the first group, after one month, the statin level changed to Rosuvastatin 5 mg daily (moderate intensity). In the second group, 40 mg of Rosuvastatin was continued for one year. Then, the participants were evaluated in terms of MACEs, including any hospitalization due to acute coronary syndrome, as well as history of stroke and myocardial Infarction, subsequent unplanned revascularization and cardiac death. The HS-CRP also checked between two groups

Official Title
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Effects of High- or Moderate-Dose Statin on 1-Year Major Adverse Cardiovascular Events (MACE) Post Percutaneous Coronary Interventions

Conditions
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Statin Dose

Intervention / Treatment
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* Drug: moderate statin dose
* Drug: high dose statin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients who have undergone PCI due to chronic stable angina Exclusion Criteria: Patients with acute coronary syndrome Primary LDL>190 mg/DL Patients who developed statin-induced myopathy or rhabdomyolysis Persistent increase in hepatic enzyme levels or hepatic failure Pregnancy and breast feeding Statin hypersensitivity Patients with history of multiple atherosclerotic events Patients who received high intensity statin before the study enrollment.

Ages Eligible for Study
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Minimum Age: 52 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: moderate dose statin<br>Patients 1 month post PCI, allocated to 5 mg rosuvastatin per day | Drug: moderate statin dose<br>* 5 mg rosuvastatin per day<br>|
| Active Comparator: high dose statin<br>patients 1 month post PCI, allocated to 40 mg rosuvastatin | Drug: high dose statin<br>* 40 mg rosuvastatin per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiovascular events (MACE) | major adverse cardiovascular events | 1 year | 
| serum level of HS-CRP |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, Stable Angina, statin therapy