Ticagrelor or Prasugrel Versus Clopidogrel in Elderly Patients With an Acute Coronary Syndrome and a High Bleeding Risk: Optimization of Antiplatelet Treatment in High-risk Elderly

Last updated: May 29, 2024
Sponsor: St. Antonius Hospital
Overall Status: Completed

Phase

4

Condition

Chest Pain

Hypercholesterolemia

Angina

Treatment

Ticagrelor or Prasugrel

Clopidogrel

Clinical Study ID

NCT02317198
PAACS01
  • Ages > 70
  • All Genders

Study Summary

A randomized controlled, open label, multicenter trial with 1000 patients aged 70 years and older, presenting with Non-ST-elevation acute coronary syndrome. Patients will be randomized to either clopidogrel or the novel P2Y12 inhibitor (ticagrelor or prasugrel). Patients will be followed for one year for outcomes such as bleeding episode requiring medical intervention and net clinical benefit (all cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 70 years of age.

  • Hospitalization for NSTEMI or UA < 72 hours

Exclusion

Exclusion Criteria:

  • Contraindication to P2Y12 inhibitors i.e. clopidogrel, prasugrel or ticagrelor:

  • Unable or unwilling to give informed consent or have a life expectancy of less thanone year.

  • Having received thrombolytic therapy within the previous 24 hours.

  • Severe renal function impairment needing dialysis.

  • Confirmed or persistent severe hypertension (Systolic Blood Pressure (SBP) > 180mmHg and/or Diastolic Blood Pressure (DBP) >110 mmHg) at randomization.

  • At increased bleeding risk, at the investigator's opinion, e.g. because ofmalignancy.

  • Cardiogenic shock (SBP ≤ 80mmHg for >30 mins) or Intra-Aortic Balloon Pump (IABP) atthe time of screening.

  • History of major surgery, severe trauma, fracture or organ biopsy within 90 daysprior to randomisation.

  • Clinically significant out of range values for platelet count or haemoglobin atscreening, in the investigator's opinion.

  • ACS under dual antiplatelet therapy, e.g. aspirin with a P2Y12 inhibitor;clopidogrel, prasugrel, ticagrelor.

  • Patients with a known CYP2C19 genotype at the time of randomization.

Study Design

Total Participants: 1011
Treatment Group(s): 2
Primary Treatment: Ticagrelor or Prasugrel
Phase: 4
Study Start date:
June 01, 2013
Estimated Completion Date:
November 30, 2019

Connect with a study center

  • St. Antonius hospital

    Nieuwegein, Utrecht 3430 EM
    Netherlands

    Site Not Available

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