POPular AGE: 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

Sponsor

St. Antonius Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02317198

Collaborator

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

1,011

Enrollment

Location

Arms

Anticipated Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Non-ST-elevation Acute Coronary Syndrome Unstable Angina Non-ST-elevation Myocardial Infarction	Drug: Clopidogrel Drug: Ticagrelor or Prasugrel	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

1011 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Nov 1, 2018

Anticipated Study Completion Date :

Nov 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention

Clopidogrel

Drug: Clopidogrel

Other Names:

Plavix

Grepid

Active Comparator: Control

Ticagrelor/Prasugrel

Drug: Ticagrelor or Prasugrel

Outcome Measures

Primary Outcome Measures

occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation [One year]
net clinical benefit at 1 year after randomisation [One year]
All cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.