Evaluation of Platelet Therapy Response in Left Ventricular Assist Device Patients

NCT06152562 | Completed

• 2 other identifiers: EK Nr: 2460/20202021-004921-62
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the incidence of any hemocompatibility related adverse event (HRAE) after LVAD placement in patients responsive to a standard aspirin dose using point-of-care platelet inhibition monitoring compared with initial non-responders who were then up-titrated to achieve a therapeutic response using individualized acetylsalicylic acid (ASA) therapy. Second, to investigate whether patients exhibit temporal changes in ASA sensitivity during LVAD support.

Conditions

End-stage Heart Failure; Cardiomyopathies; Mechanical Circulatory Support

Keywords

Left ventricular assist device

Outcome Measures

Primary Outcomes (1)

• Freedom from any hemocompatibility related adverse events (HRAEs) in initial ASA responder and initial ASA non-responder.

  The primary question is whether the two groups (initial ASA responder and initial ASA non-responder) differ with regard to freedom from any HRAEs. For this purpose, the Kaplan-Meier curves for the two groups are shown graphically (the graph also shows the number of patients at risk per year). These two curves are compared with each other using a log-rank test. The median freedom from HRAE times are reported separately for both groups, as well as the probabilities according to Kaplan-Meier for different time frames.

  freedom from any HRAE over 12 months

Secondary Outcomes (1)

• Temporal alteration in ASA therapy sensitivity during follow up

  change of ASA therapy sensitivity over 3 months

Study Arms (2)

Individualized ASA therapy group using platelet inhibition monitoring

The first VerifyNow ARU measurement will be done minimum 2 hours and at latest 24 hours after the first four doses of ASA. If the ARU is ≤ 549, the current daily ASA dose will be continued and the patient will be discharged with this dose. If the ARU is ≥ 550, the dose will be increased by 50 mg and the test is repeated after two doses. We will increase the dose step by step until the ARU decreased below 550 or a maximum ASA dose of 300 mg per day is reached. If there is no sufficient drug effect at the maximum dose assessed by VerifyNow, the patient will be count as non-responder and a change to a P2Y12-inhibitor (e.g. Clopidogrel 75 mg) is indicated. A resistance against Clopidogrel will not be examined. The other tests will be held at the first follow-up visit and six months after implantation.

Diagnostic Test: VerifyNow antiplatelet therapy response test

Standard ASA therapy

Initiation of standard dose ASA therapy as per center guidelines with HeartMate 3: 100mg/day; HVAD: 200mg/day

Interventions

VerifyNow antiplatelet therapy response test DIAGNOSTIC_TEST

VerifyNow testing after minimum of 2 hours and at latest 24 hours after the first four dosis of ASA

Individualized ASA therapy group using platelet inhibition monitoring

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of HeartMate 3 LVAD or HVAD recipients implanted at the Medical University of Vienna. Based on the initial ASA response type (responder vs. non-responder) the primary and secondary outcomes will be assessed.

You may not qualify if:

• Age: \<18 or \>75 years
• Inability to provide informed consent
• No ASA therapy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VAD Engineer

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: November 30, 2023
• Study Start: December 6, 2021
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)