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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06053983
Recruitment Status : Completed
First Posted : September 26, 2023
Last Update Posted : October 17, 2023
Sponsor:
Information provided by (Responsible Party):
Naima Shehzadi Qazi, Rawalpindi Medical College

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Mi Q Wave Device: Turbox CRP kit Drug: rosuvastatin 20 mg, Drug: atorvastatin 40 mg Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison Between Atorvastatin and Rosuvastatin in Reduction of Inflammatory Biomarkers in Patients With Acute Coronary Syndrome
Actual Study Start Date : January 1, 2023
Actual Primary Completion Date : August 1, 2023
Actual Study Completion Date : August 1, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: rosuvastatin 20 mg Device: Turbox 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.

Drug: rosuvastatin 20 mg,
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
Experimental: atorvastatin 40 mg Device: Turbox 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.

Drug: atorvastatin 40 mg
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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change C-reactive protein [ Time Frame: AFTER 4 WEEKS ]
    hs -CRP (mg/l)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06053983


Locations
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Pakistan
Rawalpindi Medical University
Rawalpindi, Pakistan
Sponsors and Collaborators
Rawalpindi Medical College
Investigators
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Study Director: asma khan Rawalpindi Medical College
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Naima Shehzadi Qazi, Dr. NAIMA SHEHZADI QAZI PGT MD CARDIOLOGY, Rawalpindi Medical College
ClinicalTrials.gov Identifier: NCT06053983    
Other Study ID Numbers: 46 /IREFIRMU 2021
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: October 17, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin
Rosuvastatin Calcium
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors