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Completed

NCT Number: NCT02317198

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

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).

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Key information

Conditions

Non-ST-elevation Acute Coronary Syndrome Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Non-ST-Elevation Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Unstable Angina Vascular Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Antonius hospital

Nieuwegein, Utrecht, 3430 EM, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 70 years of age.
  • Hospitalization for NSTEMI or UA < 72 hours

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 than one 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) > 180 mmHg and/or Diastolic Blood Pressure (DBP) >110 mmHg) at randomization.
  • At increased bleeding risk, at the investigator's opinion, e.g. because of malignancy.
  • Cardiogenic shock (SBP ≤ 80mmHg for >30 mins) or Intra-Aortic Balloon Pump (IABP) at the time of screening.
  • History of major surgery, severe trauma, fracture or organ biopsy within 90 days prior to randomisation.
  • Clinically significant out of range values for platelet count or haemoglobin at screening, 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.

Treatment and study plan

clopidogrel

Drug

Other names: Plavix, Grepid

Ticagrelor or Prasugrel

Drug

Primary outcomes

  1. occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation

    Time frame: One year

  2. net clinical benefit at 1 year after randomisation

    Time frame: One year

    All cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Collaborators

  • Frisius Medisch Centrum
  • Gelderse Vallei Hospital
  • Gelre Hospitals
  • Isala
  • Leiden University Medical Center
  • Meander Medical Center
  • Medical Center Alkmaar
  • Rijnstate Hospital
  • UMC Utrecht

Registry information

Acronym: POPular AGE

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Dec 15, 2014
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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