Effective Dose of Statin Post PCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

582 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-04-01

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

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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

Conditions

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Statin Dose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Group A, group B

Study Groups

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moderate dose statin

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

Group Type EXPERIMENTAL

moderate statin dose

Intervention Type DRUG

5 mg rosuvastatin per day

high dose statin

patients 1 month post PCI, allocated to 40 mg rosuvastatin

Group Type ACTIVE_COMPARATOR

high dose statin

Intervention Type DRUG

40 mg rosuvastatin per day

Interventions

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moderate statin dose

5 mg rosuvastatin per day

Intervention Type DRUG

high dose statin

40 mg rosuvastatin per day

Intervention Type DRUG

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.

Minimum Eligible Age

52 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No