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OpenTrials
Completed

NCT Number: NCT04923152

Effective Dose of Statin Post PCI

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

Completed

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Key information

Age range

52 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Professor kojuri cardiology clinic

Shiraz, Outside of the US, 55318, Iran

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

moderate statin dose

Drug

5 mg rosuvastatin per day

high dose statin

Drug

40 mg rosuvastatin per day

Primary outcomes

  1. major adverse cardiovascular events (MACE)

    Time frame: 1 year

    major adverse cardiovascular events

  2. serum level of HS-CRP

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2021
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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