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

Sponsor

Rawalpindi Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT06053983

Collaborator

(none)

152

Enrollment

Location

Arms

Actual Duration (Months)

21.8

Patients Per Site Per Month

Study Details

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

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

Study Type:

Interventional

Actual Enrollment :

152 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 :

Jan 1, 2023

Actual Primary Completion Date :

Aug 1, 2023

Actual Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mean Change C-reactive protein [AFTER 4 WEEKS]
hs -CRP (mg/l)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rawalpindi Medical University	Rawalpindi		Pakistan

Sponsors and Collaborators

Rawalpindi Medical College

Investigators

Study Director: asma khan, Rawalpindi Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Sep 26, 2023

Last Update Posted:

Sep 26, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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:

Acute Coronary Syndrome

Atorvastatin

Rosuvastatin Calcium

Study Results

No Results Posted as of Sep 26, 2023