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 (POPular AGE)

May 29, 2024 updated by: Jurriën M. ten Berg, MD, PhD, St. Antonius Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1011

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3430 EM
        • St. Antonius Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Clopidogrel
Drug: Clopidogrel
Other Names:
  • Plavix
  • Grepid
Active Comparator: Control
Ticagrelor/Prasugrel
Drug: Ticagrelor or Prasugrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation
Time Frame: One year
One year
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
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Collaborators

UMC Utrecht
Leiden University Medical Center
Medical Centre Leeuwarden
Rijnstate Hospital
Medical Center Alkmaar
Isala
Meander Medical Center
Gelre Hospitals
Gelderse Vallei Hospital

Investigators

  • Principal Investigator: Jurriën M ten Berg, MD, PhD, St. Antonius Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimated)

December 15, 2014

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAACS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe