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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)

Primary Purpose

Non-ST-elevation Acute Coronary Syndrome, Unstable Angina, Non-ST-elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Clopidogrel
Ticagrelor or Prasugrel
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-ST-elevation Acute Coronary Syndrome focused on measuring Elderly, P2Y12 inhibitors, clopidogrel, ticagrelor

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • St. Antonius hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Clopidogrel

Ticagrelor/Prasugrel

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 10, 2014
Last Updated
January 11, 2019
Sponsor
St. Antonius Hospital
Collaborators
UMC Utrecht, Leiden University Medical Center, Meander Medical Center, Medical Center Alkmaar, Isala, Gelre Hospitals, Gelderse Vallei Hospital, Medical Centre Leeuwarden, Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02317198
Brief 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
Acronym
POPular AGE
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital
Collaborators
UMC Utrecht, Leiden University Medical Center, Meander Medical Center, Medical Center Alkmaar, Isala, Gelre Hospitals, Gelderse Vallei Hospital, Medical Centre Leeuwarden, Rijnstate Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST-elevation Acute Coronary Syndrome, Unstable Angina, Non-ST-elevation Myocardial Infarction
Keywords
Elderly, P2Y12 inhibitors, clopidogrel, ticagrelor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1011 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Clopidogrel
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Ticagrelor/Prasugrel
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix, Grepid
Intervention Type
Drug
Intervention Name(s)
Ticagrelor or Prasugrel
Primary Outcome Measure Information:
Title
occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation
Time Frame
One year
Title
net clinical benefit at 1 year after randomisation
Description
All cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jurriën M ten Berg, MD, PhD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Antonius hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3430 EM
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32334703
Citation
Gimbel M, Qaderdan K, Willemsen L, Hermanides R, Bergmeijer T, de Vrey E, Heestermans T, Tjon Joe Gin M, Waalewijn R, Hofma S, den Hartog F, Jukema W, von Birgelen C, Voskuil M, Kelder J, Deneer V, Ten Berg J. Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial. Lancet. 2020 Apr 25;395(10233):1374-1381. doi: 10.1016/S0140-6736(20)30325-1.
Results Reference
derived
PubMed Identifier
26542508
Citation
Qaderdan K, Ishak M, Heestermans AA, de Vrey E, Jukema JW, Voskuil M, de Boer MJ, van't Hof AW, Groenemeijer BE, Vos GJ, Janssen PW, Bergmeijer TO, Kelder JC, Deneer VH, ten Berg JM. Ticagrelor or prasugrel versus clopidogrel in elderly patients with an acute coronary syndrome: Optimization of antiplatelet treatment in patients 70 years and older--rationale and design of the POPular AGE study. Am Heart J. 2015 Nov;170(5):981-985.e1. doi: 10.1016/j.ahj.2015.07.030. Epub 2015 Aug 4.
Results Reference
derived

Learn more about this trial

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

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