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CompletedNCT06053983Updated Oct 17, 2023

Comparison Between Atorvastatin and Rosuvastatin in Reduction of Inflammatory Biomarkers in Patients With Acute Coronary Syndrome

A Phase 4 interventional study of Turbox CRP kit and rosuvastatin 20 mg, in Mi Q Wave, sponsored by Rawalpindi Medical College. Completed at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by Rawalpindi Medical College · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2023, 3 years 2 months ago, and no results have been posted to the registry.
  • Registered 8 months after the study started (first participant enrolled Jan 2023, registered Sep 2023).
Phase
Phase 4
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will help us to compare atorvastatin and rosuvastatin in terms of their ability to reduce biomarkers of inflammation in patients of acute coronary syndrome

02

Conditions studied

  • Mi Q Wave
03

In context

Lead sponsor

Rawalpindi Medical College is the lead sponsor of 23 studies on the registry; 5 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with age 18 years and above, of both genders, diagnosed with acute coronary syndrome (as per operational definition) who were not taking statins previously.
  2. Patients who sign written informed consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • 1.Patients who are taking either statins and/or any other drug which lower serum lipid levels, patients with a history of statin hypersensitivity, patients in whom statins are contraindicated.

    2.Patients who will be surgically managed will be also excluded. 3.if coronary revascularization will be planned or anticipated at the time of screening.

    4.Pregnant or lactating women. 5.Patients having concomitant infections which cause the rise of inflammatory markers.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
126 participants (actual)

Study arms

  • Experimental
    rosuvastatin 20 mg

    Device: Turbox CRP kit · Drug: rosuvastatin 20 mg,

  • Experimental
    atorvastatin 40 mg

    Device: Turbox CRP kit · Drug: atorvastatin 40 mg

Interventions

  • DeviceTurbox CRP kit

    Quantitative estimation of hs-CRP will be conducted at the beginning of the study and after the treatment period using the Turbox CRP kit, which employs turbidimetry as the method of measurement.

  • The statin are most commonly used agents for prevention of cardiovascular events and recurrent episodes of ACS. Apart from their anti-lipid actions, statins show pleotropic effects which include their anti-inflammatory role. Atorvastatin and rosuvastatin are both members of statin family and have showed their effectiveness in reduction of inflammatory biomarkers in addition to their lipid lowering effects

  • The statin are most commonly used agents for prevention of cardiovascular events and recurrent episodes of ACS. Apart from their anti-lipid actions, statins show pleotropic effects which include their anti-inflammatory role. Atorvastatin and rosuvastatin are both members of statin family and have showed their effectiveness in reduction of inflammatory biomarkers in addition to their lipid lowering effects

06

What researchers measure

Primary outcomes

  1. Mean Change C-reactive protein

    hs -CRP (mg/l)

    Time frame: AFTER 4 WEEKS

07

Study locations

1 site
  • Rawalpindi Medical University
    Rawalpindi, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Aug 2023, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2023
First posted
Sep 26, 2023
StartActual
Jan 1, 2023
Primary completionActual
Aug 1, 2023
CompletionActual
Aug 1, 2023
Last update
Oct 17, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06053983
Lead sponsor
Rawalpindi Medical College
Responsible party
Naima Shehzadi Qazi (Dr. NAIMA SHEHZADI QAZI PGT MD CARDIOLOGY, Rawalpindi Medical College) — Principal investigator
First posted
Sep 26, 2023
Start date
Jan 1, 2023
Primary completion
Aug 1, 2023
Completion
Aug 1, 2023
Last update
Oct 17, 2023

Study contacts

asma khan
study director · Rawalpindi Medical College

Oversight

FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Rosuvastatin · Atorvastatin

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