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Study of effectiveness and safety of rosuvastatin, aspirin and clopidogrel in patients with acute coronary syndrome

Evaluation of safety and efficacy of fix dose combination of rosuvastatin, aspirin and clopidoGrel in patients with risk of acute cOronary syndrome: A prospective, observationaL, multicenter stuDy - GOLD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/01/017221
Enrollment
1000
Registered
2019-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: I20-I25- Ischemic heart diseases

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Aprica Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult patients of either sex of 30 to 85 years of age (inclusive both) with evidence of coronary artery disease and/or Post PCI, or having risk of coronary artery disease as determined by clinical judgment of clinician 2.Patients receiving treatment of fixed dose combination of Rosuvastatin, Aspirin and clopidogrel 3.Patient willing to provide written informed consent document

Exclusion criteria

Exclusion criteria: 1.Patients receiving any other lipid lowering agent than study drug i.e. rosuvastatin 2.Patients receiving any other antiplatelet agent than aspirin and clopidogrel

Design outcomes

Primary

MeasureTime frame
To evaluate efficacy of treatment by studying changes in following parameters. 1. CHA2DS2-VASc Score 2. Lipid levels 3. Cardiovascular morbidity and mortalityTimepoint: 4, 12 and 24 weeks—

Secondary

MeasureTime frame
Secondary outcome meausures will be 1. Mean changes in Systolic and diastolic blood pressure 2.Changes in ECG parameters at 4, 12 and 24 weeks 3.Number of patients achieving target levels of lipid levels 4.Treatment responders 5.Incidence and type of any clinical or laboratory adverse experiences. 6.Socioeconomic classification of patients Timepoint: 4, 12 and 24 weeks—

Countries

India

Contacts

Public ContactDr Amit Gajjar

Aprica Healthcare Pvt Ltd

dramit@aprican.com7573953504

Outcome results

None listed

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