Effective Dose of Statin Post PCI

Shiraz University of Medical Sciences

Status: Completed

Conditions: Statin Dose

Treatments: Drug: moderate statin dose; Drug: high dose statin

Study type: Interventional

Funder types: Other

Identifiers

NCT04923152

IR.SUMS.MED.REC.1398.620

Details and patient eligibility

About

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

Full 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

Enrollment: 582 patients

Sex: All

Ages: 52 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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582 participants in 2 patient groups

moderate dose statin

Experimental group

Description:

Patients 1 month post PCI, allocated to 5 mg rosuvastatin per day

Treatment:

Drug: moderate statin dose

high dose statin

Active Comparator group

Description:

patients 1 month post PCI, allocated to 40 mg rosuvastatin

Treatment:

Drug: high dose statin