Effective Dose of Statin Post PCI

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04923152

Enrollment

582

Registered

2021-06-11

Start date

2020-01-01

Completion date

2021-04-01

Last updated

2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Statin Dose

Keywords

PCI, Stable Angina, statin therapy

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

Interventions

DRUGmoderate statin dose

5 mg rosuvastatin per day

DRUGhigh dose statin

40 mg rosuvastatin per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Group A, group B

Intervention model description

double blind randomized

Eligibility

Sex/Gender

ALL

Age

52 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
major adverse cardiovascular events (MACE)	1 year	major adverse cardiovascular events
serum level of HS-CRP	1 year	—

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026