Does the dual antiplatelet medication of aspirin and either clopidogrel or prasugrel affect inflammatory and oxidative stress measures in individuals with acute coronary syndrome similarly?
- Conditions
- Health Condition 1: I00-I99- Diseases of the circulatory system
- Registration Number
- CTRI/2023/07/055349
- Lead Sponsor
- Pt B D Sharma PGIMS Rohtak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
18â??65-year-old patients of either sex with acute coronary syndrome (ACS) as diagnosed by a cardiologist. Patients eligible for dual antiplatelet treatment on the basis of cardiovascular risk category and American college of cardiology/American heart association guidelines
(ACC/AHA).Patients willing to participate in the study and give informed consent.
Patients who are already on any antiplatelet drug.
Patients having contraindications to the use of any study drug.
Present or past history of active bleeding.
Pregnant and lactating women, inadequate contraception.
Patients with known inflammatory/infective diseases.
Patients with severe extra cardiac diseases limiting life expectancy.
Known renal dysfunction (serum creatinine >=1.8 mg/dL in women, >=2.0 mg/dL in men).
Known hepatic impairment (aspartate aminotransferase, alanine aminotransferase >3 times upper limit of normal).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method High sensitivity C-Reactive protein (hs-CRP) <br/ ><br>Timepoint: outcome assessment will be carried out for both groups at baseline & at 4 weeks
- Secondary Outcome Measures
Name Time Method 1.To assess the change in the level of antioxidant parameter total antioxidant capacity <br/ ><br>(TAOC) at 4 weeks from <br/ ><br>baseline in both groups. <br/ ><br>2.To compare the incidence of bleeding events in two study groups during the study duration. <br/ ><br>3.To assess the change in hemoglobin & hematocrit (Packed cell volume) values at 4 weeks from baseline in both the study groups. <br/ ><br>4.To assess the incidence of withdrawal due to study drug-related adverse events in both the groups. <br/ ><br>5.To assess the safety in both groups by monitoring adverse drug reactions throughout the study. <br/ ><br> <br/ ><br>Timepoint: Safety assessment will be carried out for both groups at baseline & at 4 weeks