Back to resultsComparison Between Atorvastatin and Rosuvastatin in Reduction of Inflammatory Biomarkers in Patients With Acute Coronary Syndrome
Primary Purpose
Mi Q Wave
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Turbox CRP kit
rosuvastatin 20 mg,
atorvastatin 40 mg
Sponsored by
About this trial
This is an interventional treatment trial for Mi Q Wave
Eligibility Criteria
Inclusion Criteria: 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. 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.
Sites / Locations
- Rawalpindi Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
rosuvastatin 20 mg
atorvastatin 40 mg
Arm Description
Outcomes
Primary Outcome Measures
Mean Change C-reactive protein
hs -CRP (mg/l)
Secondary Outcome Measures
Full Information
NCT ID
NCT06053983
First Posted
September 19, 2023
Last Updated
October 15, 2023
Sponsor
Rawalpindi Medical College
1. Study Identification
Unique Protocol Identification Number
NCT06053983
Brief Title
Comparison Between Atorvastatin and Rosuvastatin in Reduction of Inflammatory Biomarkers in Patients With Acute Coronary Syndrome
Official Title
Comparison Between Atorvastatin and Rosuvastatin in Reduction of Inflammatory Biomarkers in Patients With Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rawalpindi Medical College
4. Oversight
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
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mi Q Wave
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rosuvastatin 20 mg
Arm Type
Experimental
Arm Title
atorvastatin 40 mg
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Turbox CRP kit
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
rosuvastatin 20 mg,
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
atorvastatin 40 mg
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean Change C-reactive protein
Description
hs -CRP (mg/l)
Time Frame
AFTER 4 WEEKS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
asma khan
Organizational Affiliation
Rawalpindi Medical College
Official's Role
Study Director
Facility Information:
Facility Name
Rawalpindi Medical University
City
Rawalpindi
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Between Atorvastatin and Rosuvastatin in Reduction of Inflammatory Biomarkers in Patients With Acute Coronary Syndrome
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