ARIES

• Research type

  Research Study

• Full title

  Antiplatelet Removal and HemocompatIbility EventS with the HeartMate 3 Pump

• IRAS ID

  278497

• Contact name

  Abbott Abbott

• Contact email

  joanne.obeirne@abbott.com

• Sponsor organisation

  Abbott

• Clinicaltrials.gov Identifier

  NCT04069156

• Duration of Study in the UK

  3 years, 3 months, 30 days

• Research summary

  Research Summary:
  Heart failure is characterised by the inability of the heart to pump enough blood to the vital organs. Some patients with heart failure are eligible for surgically implanted mechanical pumps that assist the heart in supplying blood to vital organs, which prolongs life and improves symptoms. The HeartMate III is a mechanical left ventricular assisted pump with CE mark approval. The objective of the study is to investigate whether a change to the standard of care blood thinning treatment regime will affect the heart mate III ventricular device. Patients with devices like the HeartMate 3 take two blood thinner medicines, specifically warfarin and aspirin. Patients implanted with devices like the HeartMate 3 experience both clotting and bleeding complications. Data suggest the HeartMate 3 may not require as much anticoagulation (blood thinners) as are normally used. This study will test if patients need aspirin together with warfarin or just warfarin alone. In other words, this study is intended to determine if aspirin is required for safe operation of the HeartMate 3 mechanical pump.

  Participants will receive either aspirin or placebo. Warfarin will still be used as per standard of care. Participants will not find out whether they are taking aspirin or placebo.

  Participants will be followed up at Baseline, Implant, Randomization, Discharge, 1 week ± 3 days, 1 month ± 7 days, 3, 6, 9 and 12 (± 30 days) then every 6 month ± 60 days until last subject has completed the 12- month follow-up (up to 4 years). Data will be collected during routine hospital visits. Participants will complete walking tests, additional blood drawn from a blood test and complete questionnaires.
  Summary of Results:
  In summary, the results presented in this report for participants enrolled in the ARIES clinical study support the safety and effectiveness of excluding aspirin as part of an antithrombotic regimen that includes vitamin K antagonists in patients supported with the HM3 LVAD. Avoidance of aspirin does not increase the risk of thromboembolism and is associated with a reduction in bleeding events. Reduced bleeding events, associated hospitalization, and cost of care emphasizes the positive impact of a Vitamin-K only antithrombotic strategy on clinical outcomes for patients with advanced heart failure supported with the HM3 LVAD.
  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04069156%2FNBTI%2F10e4AQ%2FAQ%2F492d57b9-9bdf-49cc-8f16-502333f77033%2F1%2FBoYlB6ajqG&data=05%7C02%7Csouthbirmingham.rec%40hra.nhs.uk%7Cb3ad5bc3ea2141ec1fc708dcde430527%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638629626632047438%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=mdamRIzP%2FWH6IlzNpwXAiq5YVkvmuDRXVTKDnvWBhlA%3D&reserved=0

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  20/WM/0141

• Date of REC Opinion

  22 Jun 2020

• REC opinion

  Further Information Favourable Opinion