Non-ST-elevation Acute Coronary SyndromePhase 4POPular AGENCT02317198
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 Phase 4 study testing Clopidogrel and Ticagrelor or Prasugrel in people with Non-ST-elevation Acute Coronary Syndrome and Unstable Angina, run by St. Antonius Hospital at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-ST-elevation Acute Coronary Syndrome, Unstable Angina, Non-ST-elevation Myocardial Infarction
- What is being tested?
- Clopidogrel and Ticagrelor or Prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,011 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- At least 70 years of age.
- Hospitalization for NSTEMI or UA < 72 hours
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Non-ST-elevation Acute Coronary Syndrome, Unstable Angina, Non-ST-elevation Myocardial Infarction
- Being tested
- Clopidogrel, Ticagrelor or Prasugrel
- Keywords
- Elderly, P2Y12 inhibitors, clopidogrel, ticagrelor
- Medical subject headings
- Angina, Unstable, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called Plavix, Grepid
Ticagrelor or PrasugrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Clopidogrel Receives: Drug: Clopidogrel |
| Control | Active comparator | Ticagrelor/Prasugrel Receives: Drug: Ticagrelor or Prasugrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation
Measured: One year
net clinical benefit at 1 year after randomisation
All cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startJun 2013
- Primary completionNov 2018
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-ST-elevation Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Leiden University Medical Center, Meander Medical Center, Medical Center Alkmaar, Isala, Gelre Hospitals, Gelderse Vallei Hospital, Frisius Medisch Centrum, Rijnstate Hospital
- Responsible party
- Principal investigator, Jurriën M. ten Berg, MD, PhD, St. Antonius Hospital
- Investigators
- Jurriën M ten Berg, MD, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317198
- Sponsor's protocol ID
- PAACS01
- Acronym
- POPular AGE
- Status last verified
- May 2024
- First submitted
- 10 Oct 2014
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van den Broek WWA, Gimbel ME, Hermanides RS, Runnett C, Storey RF, Knaapen P, Emans ME, Oemrawsingh RM, Cooke J, Galasko G, Walhout R, Stoel MG, von Birgelen C, van Bergen PFMM, Brinckman SL, Aksoy I, Liem A, Van't Hof AWJ, Jukema JW, Heestermans AACM, Nicastia D, Alber H, Austin D, Nasser A, Deneer V, Ten Berg JM. The impact of patient-reported frailty on cardiovascular outcomes in elderly patients after non-ST-acute coronary syndrome. Int J Cardiol. 2024 Jun 15;405:131940. doi: 10.1016/j.ijcard.2024.131940. Epub 2024 Mar 7.
PubMed 38458385van den Broek WWA, van Paassen JG, Gimbel ME, Deneer VHM, Ten Berg JM, Vreman RA. Cost-effectiveness of clopidogrel vs. ticagrelor in patients of 70 years or older with non-ST-elevation acute coronary syndrome. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 15;9(1):76-84. doi: 10.1093/ehjcvp/pvac037.
PubMed 35723240Gimbel 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.
PubMed 32334703Qaderdan 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.
PubMed 26542508
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02317198
- Acronym / sponsor ID
- POPular AGE / PAACS01
- Conditions
- Non-ST-elevation Acute Coronary Syndrome, Unstable Angina, Non-ST-elevation Myocardial Infarction
- Keywords
- Elderly, P2Y12 inhibitors, clopidogrel, ticagrelor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- UMC Utrecht, Leiden University Medical Center, Meander Medical Center, Medical Center Alkmaar, Isala, Gelre Hospitals, Gelderse Vallei Hospital, Frisius Medisch Centrum, Rijnstate Hospital
- Study start
- Jun 2013 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: ClopidogrelClopidogrel |
| Control | Active comparator | Drug: Ticagrelor or PrasugrelTicagrelor/Prasugrel |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- At least 70 years of age.
- Hospitalization for NSTEMI or UA < 72 hours
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClopidogrelAlso: Plavix, Grepid | Drug | Intervention |
| Ticagrelor or Prasugrel | Drug | Control |
Primary outcome
occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 38458385van den Broek WWA, Gimbel ME, Hermanides RS, Runnett C, Storey RF, Knaapen P, Emans ME, Oemrawsingh RM, Cooke J, Galasko G, Walhout R, Stoel MG, von Birgelen C, van Bergen PFMM, Brinckman SL, Aksoy I, Liem A, Van't Hof AWJ, Jukema JW, Heestermans AACM, Nicastia D, Alber H, Austin D, Nasser A, Deneer V, Ten Berg JM. The impact of patient-reported frailty on cardiovascular outcomes in elderly patients after non-ST-acute coronary syndrome. Int J Cardiol. 2024 Jun 15;405:131940. doi: 10.1016/j.ijcard.2024.131940. Epub 2024 Mar 7.
- Derived from this study: PubMed 35723240van den Broek WWA, van Paassen JG, Gimbel ME, Deneer VHM, Ten Berg JM, Vreman RA. Cost-effectiveness of clopidogrel vs. ticagrelor in patients of 70 years or older with non-ST-elevation acute coronary syndrome. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 15;9(1):76-84. doi: 10.1093/ehjcvp/pvac037.
- Derived from this study: PubMed 32334703Gimbel 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.
- Derived from this study: PubMed 26542508Qaderdan 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.
Related trials for Non-ST-elevation Acute Coronary Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
Active, not recruiting
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jurriën M ten Berg, MD, PhD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel and Ticagrelor or Prasugrel in people with Non-ST-elevation Acute Coronary Syndrome and Unstable Angina, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02317198, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.