CClinicalTrials.gg
CompletedNCT04923152Updated Jun 11, 2021

Effective Dose of Statin Post PCI

An interventional study of moderate statin dose and high dose statin in Statin Dose, sponsored by Shiraz University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 52 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-11.

Sponsored by Shiraz University of Medical Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jan 2020, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
582
Allocation
Randomized
Ages
52 Years to 75 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Statin Dose

Keywords

  • PCI
  • Stable Angina
  • statin therapy
03

In context

Lead sponsor

Shiraz University of Medical Sciences is the lead sponsor of 129 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
52 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • all patients who have undergone PCI due to chronic stable angina

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
582 participants (actual)

Study arms

  • Experimental
    moderate dose statin

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

    Drug: moderate statin dose

  • Active comparator
    high dose statin

    patients 1 month post PCI, allocated to 40 mg rosuvastatin

    Drug: high dose statin

Interventions

  • Drugmoderate statin dose

    5 mg rosuvastatin per day

  • Drughigh dose statin

    40 mg rosuvastatin per day

06

What researchers measure

Primary outcomes

  1. major adverse cardiovascular events (MACE)

    major adverse cardiovascular events

    Time frame: 1 year

  2. serum level of HS-CRP

    Time frame: 1 year

07

Study locations

1 site
  • Professor kojuri cardiology clinic
    Shiraz, Outside Of The US 55318, Iran, Islamic Republic of
08

References and documents

Individual participant data

Plan to share: No — Dat available on demand of reviewer

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04923152
Lead sponsor
Shiraz University of Medical Sciences
Responsible party
Javad Kojuri (Professor, Shiraz University of Medical Sciences) — Principal investigator
First posted
Jun 11, 2021
Start date
Jan 1, 2020
Primary completion
Jan 1, 2021
Completion
Apr 1, 2021
Last update
Jun 11, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion