title: Safety of Prasugrel in Indian patients - multicentric registry of 1000 cases.
abstract: BACKGROUND
  Clopidogrel has been the only available antiplatelet drug used along with aspirin in patients of ACS. In recent years 2 new antiplatelet drugs (Prasugrel and Ticagrelor) have become available. Prasugrel in the dose of 10 mg OD has been found to be more efficacious but with increased risk of major bleeding. For this reason it has not gained widespread usage in ACS patients undergoing PCI. There are no systematic data on the use of Prasugrel in Indian population.
  
  
  METHODS
  This is a prospective, multicentric, hospital registry of 1000 patients with ACS undergoing PCI who were administered Prasugrel. The primary safety endpoint of this study was major and minor bleeding while the efficacy endpoint is the composite of CV death, nonfatal MI, nonfatal stroke up to 30 days after PCI. Patients with high bleeding risk were excluded.
  
  
  RESULTS
  Most patients (91%) received loading dose of Prasugrel along with the maintenance dose getting according to the defined protocol. Patients were followed up to 30 days post procedure. Primary efficacy end point was reached in 3 patients only with two of them dying due to possible stent thrombosis and the third requiring revascularization of the target vessel for stent thrombosis. One major and 19 minor bleeding complications were recorded, with access site bleeding in 0.7% & non-access site bleeding in 1.2% of the subjects.
  
  
  CONCLUSIONS
  Prasugrel was found to be effective & not associated with a high incidence of bleeding in the high risk ACS patients when those at a high bleeding risk were excluded.
authors: Executive Director and Dean, Cardiology, Fortis Escorts Heart Institute, New Delhi, India. Electronic address: upendra.kaul@fortishealthcare.com.
authors: Upendra
authors: U
authors: Kaul
authors: Associate Consultant, Interventional Cardiology, Fortis Escorts Heart Institute, New Delhi, India.
authors: Arvind
authors: A
authors: Sethi
authors: Chief Clinical Research Coordinator, Fortis Escorts Heart Institute, New Delhi, India.
authors: P
authors: P
authors: Arambam
authors: Director, Non Invasive Cardiology & Head of Department Heart Command & Emergency, Fortis Escorts Heart Institute, New Delhi, India.
authors: A K
authors: AK
authors: Omar
authors: Senior Consultant, Department of Cardiology, Fortis Hospital, Bangalore, India.
authors: R
authors: R
authors: Keshava
authors: Senior Consultant, Department of Cardiology, Fortis Escorts Hospital, Jaipur, India.
authors: Sanjeeb
authors: S
authors: Roy
authors: Chief, Cardiology Intervention, Fortis Hospital, Kolkata, India.
authors: Shuvanan
authors: S
authors: Ray
authors: Director, Department of Cardiology, Fortis Hospital, Mohali, India.
authors: Rakesh
authors: R
authors: Jaswal
authors: Principal Consultant, Fortis Hospital, Vasant Kunj, New Delhi, India.
authors: Ripan K
authors: RK
authors: Gupta
authors: Senior Consultant & Head of Interventional Cardiology, Fortis Escorts Hospital, Faridabad, India.
authors: Rakesh Rai
authors: RR
authors: Sapra
authors: Director, Department of Cardiology, Fortis Hospital, Navi Mumbai, India.
authors: Rane Sandip
authors: RS
authors: Keshav
authors: Interventional Cardiologist, Fortis Hospital, Bangalore, India.
authors: Rajpal
authors: R
authors: Singh
authors: Consultant, Department of Cardiology, Fortis Hospital, Noida, India.
authors: Vineet
authors: V
authors: Bhatia
authors: Associate Director, Department of Cardiology, Fortis Hospital, Shalimar Bagh, Delhi, India.
authors: Vinay
authors: V
authors: Sanghi
authors: Director, Department of Cardiology, Fortis Hospital, Amritsar, India.
authors: Arun
authors: A
authors: Chopra
mesh_terms: D054058:Acute Coronary Syndrome / Q000601:surgery*; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000068799:Prasugrel Hydrochloride / Q000008:administration & dosage* / Q000009:adverse effects; D012042:Registries
chemical_list: D010975:Platelet Aggregation Inhibitors; D000068799:Prasugrel Hydrochloride
keywords: Bleeding; Prasugrel; Safety
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