Characterization of acute coronary syndrome patients that switch from dual antiplatelet therapy to monotherapy with clopidogrel or aspirin

Study type
Protocol
Date of Approval
Study reference ID
18_209
Lay Summary

Heart attacks and certain types of chest pain are known medically as acute coronary syndrome. Clopidogrel is a medication commonly used with aspirin by acute coronary syndrome patients at risk for harmful blood clots. It has been reported that some acute coronary syndrome patients take clopidogrel and aspirin for a period of time and in consultation with their physician, later switch to take only clopidogrel or only aspirin. This study seeks to examine these changes in medication use and the health outcomes of treated patients.

Adult acute coronary syndrome patients are studied for up to two years. During this time, patients are monitored for changes in medication and health. The findings of this study can provide valuable insight on treatments for acute coronary syndrome.

Technical Summary

Objective: To describe the characteristics of acute coronary syndrome patients that switch from dual antiplatelet therapy to monotherapy with clopidogrel or aspirin.

Methods: Acute coronary syndrome patients in CPRD will be evaluated to track changes in therapy and subsequent health outcomes.

Analysis: Descriptive statistics will be conducted. The proportion of acute coronary syndrome patients that switch therapies will be calculated. Timing of switching will be calculated. Comorbidities will be characterized.

Health Outcomes to be Measured

Change in therapy - primary
- Revascularization- secondary
- Nonfatal myocardial infarction - secondary
- Cardiovascular death - secondary
- Nonfatal stroke - secondary
- Major bleeding - secondary

Collaborators

Christopher Ronk - Chief Investigator - Sanofi Pasteur SA (France) - office closed
Christopher Ronk - Corresponding Applicant - Sanofi Pasteur SA (France) - office closed
Shalini Girotra - Collaborator - Sanofi US Services Inc (USA)
Sumit Verma - Collaborator - Evidera, Inc

Linkages

HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data