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?

Comparative evaluation of effects of clopidogrel versus prasugrel in combination with aspirin as dual antiplatelet therapy on inflammatory and oxidative stress parameters in patients with acute coronary syndrome. A randomized, open-label, parallel-group study. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055349

Enrollment

Registered

2023-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I00-I99- Diseases of the circulatory system

Interventions

Intervention1: aspirin plus clopidogrel: group A with Aspirin (150mg-300mg) loading dose and maintenance dose 75mg plus clopidogrel (300mg-600mg) loading dose and maintenance dose of 75 mg once a day

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

Measure	Time frame
High sensitivity C-Reactive protein (hs-CRP) Timepoint: outcome assessment will be carried out for both groups at baseline & at 4 weeks	—

Secondary

Measure	Time frame
1.To assess the change in the level of antioxidant parameter total antioxidant capacity (TAOC) at 4 weeks from baseline in both groups. 2.To compare the incidence of bleeding events in two study groups during the study duration. 3.To assess the change in hemoglobin & hematocrit (Packed cell volume) values at 4 weeks from baseline in both the study groups. 4.To assess the incidence of withdrawal due to study drug-related adverse events in both the groups. 5.To assess the safety in both groups by monitoring adverse drug reactions throughout the study. Timepoint: Safety assessment will be carried out for both groups at baseline & at 4 weeks	—

Measure

Time frame

1.To assess the change in the level of antioxidant parameter total antioxidant capacity (TAOC) at 4 weeks from baseline in both groups. 2.To compare the incidence of bleeding events in two study groups during the study duration. 3.To assess the change in hemoglobin & hematocrit (Packed cell volume) values at 4 weeks from baseline in both the study groups. 4.To assess the incidence of withdrawal due to study drug-related adverse events in both the groups. 5.To assess the safety in both groups by monitoring adverse drug reactions throughout the study. Timepoint: Safety assessment will be carried out for both groups at baseline & at 4 weeks

—

Countries

India

Contacts

Public ContactV Shanmugapriya

Pt B D Sharma PGIMS, Rohtak

shanmugapriyavinayagam@gmail.com6379816527

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026