Effectiveness and safety of low dose rivaroxaban plus aspirin in patients with Chronic Coronary Syndrome and high ischemic risk. (Dutch CCS Registry)

Study identification

• EU PAS number:
  EUPAS105067
• Study ID:
  105068
• Official title and acronym:
  Effectiveness and safety of low dose rivaroxaban plus aspirin in patients with Chronic Coronary Syndrome and high ischemic risk. (Dutch CCS Registry)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  A registry to describe the impact in terms of effectiveness and safety of the combination treatment of rivaroxaban 2.5 mg twice daily with aspirin on clinical outcomes and practices in a real-life Dutch patient population that are at high risk of ischemic events
• Study status:
  Ongoing

Research institutions and networks

Institutions

Isala

OLVG Amsterdam, Zuyderland Medical Centre Heerlen, Rijnstate Arnhem, Haaglanden Medical Centre Den Haag, Isala Zwolle & Meppel, Jeroen Bosch Hospital Den Bosch, Medisch Spectrum Twente Enschede, St Antonius Nieuwegein, Elisabeth Tweesteden hospital Tilburg, HAGA Den Haag Viecuri Venlo

Study timelines

Date when funding contract was signed

Planned:21/08/2020

Actual:21/08/2020

Study start date

Actual:21/12/2021

Date of final study report

Planned:31/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer

Regulatory

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

Other study registration identification numbers and links

Clinicaltrials.gov: NCT04753372 URL:https://clinicaltrials.gov/ct2/show/NCT04753372?term=Dutch+CCS+registry&cond=Chronic+Coronary+Syndrome&cntry=NL&draw=2&rank=1 Registration number Dutch Ethical Committee: AW21.028/W20.215 /NWMO20.09.037