Effective Dose of Statin Post PCI

Not Applicable

Completed

• Conditions: Statin Dose
• Interventions: Drug: moderate statin dose; Drug: high dose statin

• Registration Number: NCT04923152
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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

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

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-04-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-06-10
• Last Update Submitted: 2021-06-10
• Study First Posted: 2021-06-11
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 582

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate dose statin	moderate statin dose	Patients 1 month post PCI, allocated to 5 mg rosuvastatin per day
high dose statin	high dose statin	patients 1 month post PCI, allocated to 40 mg rosuvastatin

Primary Outcome Measures

Name	Time	Method
major adverse cardiovascular events (MACE)	1 year	major adverse cardiovascular events
serum level of HS-CRP	1 year

Trial Locations

Locations (1)

Professor kojuri cardiology clinic; 🇮🇷 Shiraz, Outside Of The US, Iran, Islamic Republic of