Date: {{$ActivityAssignDate}}

Dear Dr. {{$doctorName}},


Subject: Evaluation of Drug utilization pattern of Ticagrelor in patients with Acute Coronary Syndrome: A Retrospective, Cross sectional Study.


In India, cardiac diseases affect approximately 45 million patients, of whom more than 30 million have CAD. Acute coronary syndrome (ACS), a complication of coronary artery disease (CAD) comprises of ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), and unstable angina (UA).The prevalence of CAD and the incidence of ACS also are very high among Indians due to changes in the lifestyle, westernization of the food practices, increasing prevalence of diabetes mellitus and probably genetic factors. Acute coronary syndrome (ACS), which accounts for around half of global burden, is the leading cause of mortality in the Asia–Pacific region.


Thrombus formation in ACS is principally driven by platelet aggregation. In patients with ACS, there is a central role played by platelet inhibition in both treatment and prevention of atherothrombotic events. Oral antiplatelet therapy recommended for secondary prevention include the cyclooxygenase-1 inhibitor aspirin, and the platelet adenosine diphosphate P2Y12 receptor inhibitors clopidogrel, prasugrel, and ticagrelor. Dual Antiplatelet Therapy (DAPT) refers to the combination of aspirin and a P2Y12 receptor inhibitor. DAPT has been shown to reduce recurrent major ischemic events in patients with ACS.


The 2018 ESC guideline on myocardial revascularization in NSTE ACS and STEMI has given 1A level of recommendation for P2Y12 inhibitor in addition to Aspirin for at least 12 months unless there is contraindication such as bleeding. The guidelines has also preferred Ticagrelor over Clopidogrel, unless the former agents are not available.


In patients with bleeding risk the 2021 AHA/ACC/SCAI guideline for coronary revascularization has recommended a short duration therapy (1-3 months) of DAPT after percutaneous revascularization in case of stable ischemic heart disease to reduce the risk of bleeding events. This should be followed by stopping of Aspirin and continuation of P2Y12 inhibitor monotherapy.


Thus, it is evident that even in presence of guidelines directed therapy for ACS, the mortality rate is higher in India. This warrants for real world study to understand drug utilization pattern and adherence to above recommendations.


In lieu of the same the current retrospective cross sectional study is planned to evaluate the drug utilization pattern of Ticagrelor among treating physicians in cases of ACS, duration of Ticagrelor, and factors for discontinuation. This study will also help understand ACS disease profile, and associated comorbidities in India.


We invite you to participate in this study. On acceptance, you will need to capture the relevant data as mentioned in the standard Data Collection Form (DCF) provided, from the patient’s medical records (case papers and investigational reports – hereafter referred as source documents).



We would recommend you to capture data fulfilling the criteria as outlined in the protocol and whose relevant laboratory investigations are available for the preceding 3 months.


We wish to inform you that the DCF will capture all data in de-identified form and any identifiable parameters which may potentially disclose the identity of the patient such as name or address will strictly not be captured so as to ensure we maintain patient confidentiality. We would encourage you to carefully fill all available information to the fullest as recommended in the DCF.


In alignment with good clinical research practices, an independent CRO will monitor this study and do the source data verification of the data captured in the DCF with copies of the patients’ source medical records (case papers and investigational reports) to ensure that the data entered in the DCFs are accurate and in alignment with the patients’ medical records.


If you agree to participate in the said study, we would request you to sign and return the enclosed reply along with your visiting card for accuracy of records.



With regards,



___________________

Sun Pharma Laboratories Limited

Sun House, 201/B1, Western Express Highway,

Goregaon (East), Mumbai,

Maharashtra (India) – 400 063,