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

Mi Q Wave Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06053983
• Other study ID #: 46 /IREFIRMU 2021
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2023
• Source: Rawalpindi Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Mi Q Wave

Intervention

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
• 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

Locations

Country	Name	City	State
Pakistan	Rawalpindi Medical University	Rawalpindi

Sponsors (1)

Lead Sponsor	Collaborator
Rawalpindi Medical College

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change C-reactive protein	hs -CRP (mg/l)	AFTER 4 WEEKS