Acute Coronary SyndromePhase 4NCT01777503
The Elderly ACS II Trial
A Phase 4 study testing prasugrel and Clopidogrel in people with Acute Coronary Syndrome and Coronary Arteriosclerosis, run by Azienda USL Reggio Emilia - IRCCS at 2 sites in Italy.
Trial summary
The objective of this study is to compare reduced-dose prasugrel and standard dose clopidogrel in patients older than 74 years with ACS, including non-ST-elevation (NSTEACS) and ST-elevation (STEMI) patients, undergoing early PCI. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Arteriosclerosis, Myocardial Ischemia
- What is being tested?
- prasugrel and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,457 participants
- Where
- 2 sitesItaly
- Study dates
- Nov 2012to 19 Dec 2017
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients >74 years of age hospitalized for an ACS, with or without STE, with an onset of symptoms during the previous 72 hours, and candidates to an early PCI.
- STEMI patients may be randomized upon first diagnosis, provided they do not meet any exclusion criteria. STEMI patients should not exceed 50 percent of the global population of the study
- Eligible NSTEACS patients may be randomized after coronary angiography. To be eligible, NSTEACS patients must have at least one of the following characteristics:
- elevated troponin levels;
- diabetes mellitus;
- prior MI;
- at least one new ischemic episode while on standard treatment during the index hospitalization;
- ACS due to stent thrombosis.
Who cannot join
- History of stroke or transient ischemic attack (TIA)
- Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
- Hemoglobin level on admission <10 g/dl, unless this is considered to be secondary to renal dysfunction or known myelodysplasia.
- Secondary causes of acute myocardial ischemia.
- Known current platelet count < 90,000 cells/mL.
- Ongoing oral anticoagulant treatment or an INR known to be >1.5 at the time of screening.
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- Concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol.
- Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization
- Inability to give at least verbal informed consent to the study.
- Contraindications to the use of clopidogrel or prasugrel as per package leaflet.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Ospedaliera "Ospedale Civile di Legnano"
Legnano, MI, 20025
Arcispedale Santa Maria Nuova- IRCCS
Reggio Emilia, Italy, 42123
About this study
Official title: Phase IV: A Comparison of Reduced-dose Prasugrel and Clopidogrel in Elderly Patients With Acute Coronary Syndrome Undergoing Early Percutaneous Coronary Intervention (PCI)
The objective of this study is to compare reduced-dose prasugrel and standard dose clopidogrel in patients older than 74 years with ACS, including non-ST-elevation (NSTEACS) and ST-elevation (STEMI) patients, undergoing early PCI. The primary endpoint of the trial will be the one-year composite of (all-cause)death, myocardial infarction, stroke and re-hospitalization due to cardiovascular reasons or bleeding.
- Conditions
- Acute Coronary Syndrome, Coronary Arteriosclerosis, Myocardial Ischemia, Cardiovascular Diseases
- Being tested
- prasugrel, Clopidogrel
- Keywords
- acute coronary syndrome, elderly, percutaneous revascularization, antiaggregant drugs
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease, Myocardial Ischemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prasugrelDrug
Also called Efient
prasugrel 5 mg o.d.
ClopidogrelDrug
Also called Plavix
75 mg o.d.
| Study group | Role | What they receive |
|---|---|---|
| prasugrel | Experimental | prasugrel 60 mg loading dose, followed by 5 mg once daily until the end of follow-up Receives: Drug: prasugrel |
| clopidogrel | Active comparator | Clopidogrel 300 mg loading dose followed by 75 mg once day until the end of follow-up Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of all-cause mortality, myocardial infarction (MI), disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year
Measured: 1 year
Secondary outcomes (1)
The composite of burden of recurrent cardiovascular (CV) events, CV mortality, all-cause mortality and MI, major bleeding, any stroke, total number of days spent in hospital.
definition of major bleeding:
- Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding within 1 year (for bleedings occurring during index or subsequent hospitalizations)
- BARC type IV bleeding within 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startNov 2012
- Primary completion25 Jan 2017
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Collaborators
- ANMCO Italian Association of Hospital Cardiologist, Italian Society of Invasive Cardiology, A. Manzoni Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777503
- Sponsor's protocol ID
- EudraCT Number: 2012-002882-37
- Status last verified
- Oct 2016
- First submitted
- 21 Jan 2013
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Crimi G, Morici N, Ferrario M, Ferri LA, Piatti L, Grosseto D, Cacucci M, Mandurino Mirizzi A, Toso A, Piscione F, De Carlo M, Elia LR, Trimarco B, Bolognese L, Bovenzi FM, De Luca G, Savonitto S, De Servi S. Time Course of Ischemic and Bleeding Burden in Elderly Patients With Acute Coronary Syndromes Randomized to Low-Dose Prasugrel or Clopidogrel. J Am Heart Assoc. 2019 Jan 22;8(2):e010956. doi: 10.1161/JAHA.118.010956.
PubMed 30636561Savonitto S, Ferri LA, Piatti L, Grosseto D, Piovaccari G, Morici N, Bossi I, Sganzerla P, Tortorella G, Cacucci M, Ferrario M, Murena E, Sibilio G, Tondi S, Toso A, Bongioanni S, Ravera A, Corrada E, Mariani M, Di Ascenzo L, Petronio AS, Cavallini C, Vitrella G, Rogacka R, Antonicelli R, Cesana BM, De Luca L, Ottani F, De Luca G, Piscione F, Moffa N, De Servi S; Elderly ACS 2 Investigators. Comparison of Reduced-Dose Prasugrel and Standard-Dose Clopidogrel in Elderly Patients With Acute Coronary Syndromes Undergoing Early Percutaneous Revascularization. Circulation. 2018 Jun 5;137(23):2435-2445. doi: 10.1161/CIRCULATIONAHA.117.032180. Epub 2018 Feb 19.
PubMed 29459361Ferri LA, Morici N, Grosseto D, Tortorella G, Bossi I, Sganzerla P, Cacucci M, Sibilio G, Tondi S, Toso A, Ferrario M, Gandolfo N, Ravera A, Mariani M, Corrada E, Di Ascenzo L, Petronio AS, Cavallini C, Moffa N, De Servi S, Savonitto S. A comparison of reduced-dose prasugrel and standard-dose clopidogrel in elderly patients with acute coronary syndromes undergoing early percutaneous revascularization: Design and rationale of the randomized Elderly-ACS 2 study. Am Heart J. 2016 Nov;181:101-106. doi: 10.1016/j.ahj.2016.08.010. Epub 2016 Aug 26.
PubMed 27823681
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV: A Comparison of Reduced-dose Prasugrel and Clopidogrel in Elderly Patients With Acute Coronary Syndrome Undergoing Early Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT01777503
- Acronym / sponsor ID
- EudraCT Number: 2012-002882-37
- Conditions
- Acute Coronary Syndrome, Coronary Arteriosclerosis, Myocardial Ischemia, Cardiovascular Diseases
- Keywords
- acute coronary syndrome, elderly, percutaneous revascularization, antiaggregant drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,457 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Collaborators
- ANMCO Italian Association of Hospital Cardiologist, Italian Society of Invasive Cardiology, A. Manzoni Hospital
- Study start
- Nov 2012 (actual)
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 29 Jan 2013 (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.
The objective of this study is to compare reduced-dose prasugrel and standard dose clopidogrel in patients older than 74 years with ACS, including non-ST-elevation (NSTEACS) and ST-elevation (STEMI) patients, undergoing early PCI. The primary endpoint of the trial will be the one-year composite of (all-cause)death, myocardial infarction, stroke and re-hospitalization due to cardiovascular reasons or bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prasugrel | Experimental | Drug: prasugrelprasugrel 60 mg loading dose, followed by 5 mg once daily until the end of follow-up |
| clopidogrel | Active comparator | Drug: ClopidogrelClopidogrel 300 mg loading dose followed by 75 mg once day until the end of follow-up |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Patients >74 years of age hospitalized for an ACS, with or without STE, with an onset of symptoms during the previous 72 hours, and candidates to an early PCI.
- STEMI patients may be randomized upon first diagnosis, provided they do not meet any exclusion criteria. STEMI patients should not exceed 50 percent of the global population of the study
- Eligible NSTEACS patients may be randomized after coronary angiography. To be eligible, NSTEACS patients must have at least one of the following characteristics:
Key exclusion criteria (10 listed)
- History of stroke or transient ischemic attack (TIA)
- Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
- Hemoglobin level on admission <10 g/dl, unless this is considered to be secondary to renal dysfunction or known myelodysplasia.
- Secondary causes of acute myocardial ischemia.
- Known current platelet count < 90,000 cells/mL.
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 |
|---|---|---|
| prasugrelAlso: Efientprasugrel 5 mg o.d. | Drug | prasugrel |
| ClopidogrelAlso: Plavix75 mg o.d. | Drug | clopidogrel |
Primary outcome
The composite of all-cause mortality, myocardial infarction (MI), disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year
Time frame: 1 year
1 secondary outcome
The composite of burden of recurrent cardiovascular (CV) events, CV mortality, all-cause mortality and MI, major bleeding, any stroke, total number of days spent in hospital.
Time frame: 1 year
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 24 Jun 2025.
- Derived from this study: PubMed 30636561Crimi G, Morici N, Ferrario M, Ferri LA, Piatti L, Grosseto D, Cacucci M, Mandurino Mirizzi A, Toso A, Piscione F, De Carlo M, Elia LR, Trimarco B, Bolognese L, Bovenzi FM, De Luca G, Savonitto S, De Servi S. Time Course of Ischemic and Bleeding Burden in Elderly Patients With Acute Coronary Syndromes Randomized to Low-Dose Prasugrel or Clopidogrel. J Am Heart Assoc. 2019 Jan 22;8(2):e010956. doi: 10.1161/JAHA.118.010956.
- Derived from this study: PubMed 29459361Savonitto S, Ferri LA, Piatti L, Grosseto D, Piovaccari G, Morici N, Bossi I, Sganzerla P, Tortorella G, Cacucci M, Ferrario M, Murena E, Sibilio G, Tondi S, Toso A, Bongioanni S, Ravera A, Corrada E, Mariani M, Di Ascenzo L, Petronio AS, Cavallini C, Vitrella G, Rogacka R, Antonicelli R, Cesana BM, De Luca L, Ottani F, De Luca G, Piscione F, Moffa N, De Servi S; Elderly ACS 2 Investigators. Comparison of Reduced-Dose Prasugrel and Standard-Dose Clopidogrel in Elderly Patients With Acute Coronary Syndromes Undergoing Early Percutaneous Revascularization. Circulation. 2018 Jun 5;137(23):2435-2445. doi: 10.1161/CIRCULATIONAHA.117.032180. Epub 2018 Feb 19.
- Derived from this study: PubMed 27823681Ferri LA, Morici N, Grosseto D, Tortorella G, Bossi I, Sganzerla P, Cacucci M, Sibilio G, Tondi S, Toso A, Ferrario M, Gandolfo N, Ravera A, Mariani M, Corrada E, Di Ascenzo L, Petronio AS, Cavallini C, Moffa N, De Servi S, Savonitto S. A comparison of reduced-dose prasugrel and standard-dose clopidogrel in elderly patients with acute coronary syndromes undergoing early percutaneous revascularization: Design and rationale of the randomized Elderly-ACS 2 study. Am Heart J. 2016 Nov;181:101-106. doi: 10.1016/j.ahj.2016.08.010. Epub 2016 Aug 26.
- Design and rationale of the randomized Elderly-ACS 2 studyLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prasugrel and Clopidogrel in people with Acute Coronary Syndrome and Coronary Arteriosclerosis, run by Azienda USL Reggio Emilia - IRCCS at 2 sites in Italy.
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 8 inclusion and 10 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
The composite of all-cause mortality, myocardial infarction (MI), disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year (time frame: 1 year). 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 NCT01777503, which also lists 3 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 24 Jun 2025.