Clinical trial
Comparison Between Atorvastatin and Rosuvastatin in Reduction of Inflammatory Biomarkers in Patients With Acute Coronary Syndrome
Name
46 /IREFIRMU 2021
Description
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
Trial arms
Trial start
2023-01-01
Estimated PCD
2023-08-01
Trial end
2023-08-01
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
atorvastatin 40 mg, rosuvastatin 20 mg
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
Arms:
rosuvastatin 20 mg
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
Arms:
atorvastatin 40 mg
Size
126
Primary endpoint
Mean Change C-reactive protein
AFTER 4 WEEKS
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 126, 'type': 'ACTUAL'}}
Updated at
2023-10-17
1 organization
2 products
1 indication
Organization
Rawalpindi Medical CollegeProduct
RosuvastatinIndication
Myocardial infarction with Q waveProduct
Atorvastatin