Real-world Comparisons of Stroke, Major Bleeding, Myocardial Infarction, Acute Limb Ischemia and Death among Non-Valvular Atrial Fibrillation Patients Diagnosed With Coronary Artery Disease/Peripheral Arterial Disease who Initiated Oral Anticoagulation Therapies (CAD PAD)

Study identification

• EU PAS number:
  EUPAS18970
• Study ID:
  23575
• Official title and acronym:
  Real-world Comparisons of Stroke, Major Bleeding, Myocardial Infarction, Acute Limb Ischemia and Death among Non-Valvular Atrial Fibrillation Patients Diagnosed With Coronary Artery Disease/Peripheral Arterial Disease who Initiated Oral Anticoagulation Therapies (CAD PAD)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The study will be a longitudinal retrospective cohort analysis using the CMS fee-for-service (FFS) Medicare database. The study period will be from January 1, 2012 through December 31, 2014 or until the last date of the data cut available at the time of execution of the study.This study will evaluate the patient profiles, current antithrombotic patterns and real-world clinical outcomes among NVAF patients with CAD and/or PAD.Aim 1: To compare the risk of myocardial infarction (MI), stroke, acute limb ischemia, all-cause death and a composite of these endpoints among patients initiating OACs (warfarin, apixaban, rivaroxaban and dabigatran). Aim 2: To compare the risk of major bleeding among patients initiating OACs.Aim 3: To compare the risk of stroke and stroke/SE among patients initiating OACs.Aim 4: To compare healthcare resource use and costs among patients initiating different OACs.Aim 5: To describe the baseline demographic and clinical characteristics among patients initiating OACs (warfarin, apixaban, rivaroxaban and dabigatran)
• Study status:
  Finalised

Research institutions and networks

Institutions

SIMr STATinMED

Study timelines

Date when funding contract was signed

Actual: 02/01/2017

Study start date

Planned: 09/05/2017

Actual: 09/05/2017

Date of final study report

Planned: 11/04/2018

Actual: 11/04/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable