Acute Coronary SyndromeNCT00510185
Early Aggressive Versus Initially Conservative Therapy in Elderly Patients With Non-ST-Elevation Acute Coronary Syndrome
A study testing systematic coronary intervention and coronary intervention only for cases refractory to medical therapy in people with Acute Coronary Syndrome, run by Niguarda Hospital at 1 site in Italy.
Trial summary
A randomized study comparing an early aggressive with an initially conservative strategy in patients >74 y.o. with non-ST-elevation acute coronary syndrome. This study had generated a secondary one: "Causes of death in elderly patients with Non-ST-Elevation Acute Coronary Syndrome; predictors of in-hospital and… Read more about this study
- Who is it for?
- Ages 74 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- systematic coronary intervention and coronary intervention only for cases refractory to medical therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 313 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2007to Jun 2011
- Phase
- Interventional
- 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 74 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Over 74 years of age.
- Have had symptoms suggestive of acute myocardial ischemia at rest within 48 hours prior to randomization, and ischemic ECG changes or elevated levels of biochemical markers of myocardial damage.
- Provide written informed consent before randomization.
Who cannot join
- Secondary causes of acute myocardial ischemia.
- Ongoing myocardial ischemia despite maximally titrated anti-ischemic therapy (invasive strategy recommended).
- Ongoing signs of acute heart failure despite treatment (invasive strategy recommended).
- Percutaneous coronary intervention or bypass surgery within 30 days prior to randomization.
- A serum creatinine level greater than 2.5 mg/dL.
- Active internal bleeding, history of hemorrhagic diathesis or recent transfusion of red blood cells, whole blood or platelets.
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- History of cerebrovascular accident within the previous month.
- Known current platelet count < 90,000 cells/mL.
- Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Italian Elderly ACS Study
A randomized study comparing an early aggressive with an initially conservative strategy in patients >74 y.o. with non-ST-elevation acute coronary syndrome.
This study had generated a secondary one:
"Causes of death in elderly patients with Non-ST-Elevation Acute Coronary Syndrome; predictors of in-hospital and follow-up death"
Read the detailed description
Patients >74 y.o. with non-ST-elevation acute coronary syndrome will be randomised to an early aggressive (coronary angiography within 72 hours followed, when indicated, by revascularization) or an initially conservative strategy (medical therapy, and coronary angiography only for refractory ischemia).
As reported in Amendment 1, the trial was stopped in May 2010 after the enrolment of 313 patients, which was the minimum sample size calculated in order to achieve a 80% power of detecting a difference in the primary-endpoint rate from 40% in the conservative arm to 25% in the invasive arm, based upon the log-rank test for survival curves (1-beta 0.80; 2-tailed alpha 0.05)
- Conditions
- Acute Coronary Syndrome
- Being tested
- systematic coronary intervention, coronary intervention only for cases refractory to medical therapy
- Keywords
- coronary artery disease, coronary angioplasty, coronary artery bypass surgery, elderly
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic coronary interventionOther
Coronary angiography within 72 hrs
coronary intervention only for cases refractory to medical therapyOther
Initially conservative treatment with coronary angiography only for recurrent ischemia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Coronary angiography within 72h and revascularization as clinical indicated Receives: Other: systematic coronary intervention |
| 2 | Sham comparator | Initially conservative treatment with coronary angiography only for recurrent ischemia Receives: Other: coronary intervention only for cases refractory to medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding within 1 yr.
Measured: 1 year
Secondary outcomes (1)
CV mortality at 1 yr; All-causes mortality, myocardial re/infarction 1 yr; Composite of death, myocardial re/infarction, disabling stroke, rehospitalization due to cardiovascular or clinically bleeding causes at 1 yr; Major bleeding, stroke at 1 yr
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 posted1 Aug 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2010
- Study completionJun 2011
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Society of Cardiology
- Responsible party
- Sponsor
- Investigators
- Stefano Savonitto, MD, Principal investigator, Azienda Ospedaliera Ospedale Niguarda Ca' Granda-Dept. of Cardiology "A. De Gasperis"Stefano De Servi, MD, Principal investigator, Dept. of Cardiology - Ospedale Civile di Legnano - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510185
- Sponsor's protocol ID
- Italian Elderly ACS Study
- Status last verified
- Mar 2019
- First submitted
- 31 Jul 2007
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Savonitto S, De Servi S, Petronio AS, Bolognese L, Cavallini C, Greco C, Indolfi C, Visconti LO, Piscione F, Ambrosio G, Galvani M, Marzocchi A, Santilli I, Steffenino G, Maseri A. Early aggressive vs. initially conservative treatment in elderly patients with non-ST-elevation acute coronary syndrome: the Italian Elderly ACS study. J Cardiovasc Med (Hagerstown). 2008 Mar;9(3):217-26. doi: 10.2459/JCM.0b013e3282f7c8df.
PubMed 18301136Toso A, Servi SD, Leoncini M, Morici N, Murena E, Antonicelli R, Cavallini C, Petronio AS, Steffenino G, Piscione F, Bellandi F, Savonitto S. Acute Kidney Injury in Elderly Patients With Non-ST Elevation Acute Coronary Syndrome: Insights From the Italian Elderly: ACS Study. Angiology. 2015 Oct;66(9):826-30. doi: 10.1177/0003319714567738. Epub 2015 Jan 15.
PubMed 25593211Savonitto S, Morici N, Cavallini C, Antonicelli R, Petronio AS, Murena E, Olivari Z, Steffenino G, Bonechi F, Mafrici A, Toso A, Piscione F, Bolognese L, De Servi S. One-year mortality in elderly adults with non-ST-elevation acute coronary syndrome: effect of diabetic status and admission hyperglycemia. J Am Geriatr Soc. 2014 Jul;62(7):1297-303. doi: 10.1111/jgs.12900. Epub 2014 Jun 10.
PubMed 24917216Savonitto S, Cavallini C, Petronio AS, Murena E, Antonicelli R, Sacco A, Steffenino G, Bonechi F, Mossuti E, Manari A, Tolaro S, Toso A, Daniotti A, Piscione F, Morici N, Cesana BM, Jori MC, De Servi S; Italian Elderly ACS Trial Investigators. Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial. JACC Cardiovasc Interv. 2012 Sep;5(9):906-16. doi: 10.1016/j.jcin.2012.06.008.
PubMed 22995877
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Elderly ACS Study
- ClinicalTrials.gov ID
- NCT00510185
- Acronym / sponsor ID
- Italian Elderly ACS Study
- Conditions
- Acute Coronary Syndrome
- Keywords
- coronary artery disease, coronary angioplasty, coronary artery bypass surgery, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Collaborators
- Italian Society of Cardiology
- Study start
- Oct 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Aug 2007 (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 study comparing an early aggressive with an initially conservative strategy in patients >74 y.o. with non-ST-elevation acute coronary syndrome.
This study had generated a secondary one:
"Causes of death in elderly patients with Non-ST-Elevation Acute Coronary Syndrome; predictors of in-hospital and follow-up death"
Detailed description
Patients >74 y.o. with non-ST-elevation acute coronary syndrome will be randomised to an early aggressive (coronary angiography within 72 hours followed, when indicated, by revascularization) or an initially conservative strategy (medical therapy, and coronary angiography only for refractory ischemia).
As reported in Amendment 1, the trial was stopped in May 2010 after the enrolment of 313 patients, which was the minimum sample size calculated in order to achieve a 80% power of detecting a difference in the primary-endpoint rate from 40% in the conservative arm to 25% in the invasive arm, based upon the log-rank test for survival curves (1-beta 0.80; 2-tailed alpha 0.05)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: systematic coronary interventionCoronary angiography within 72h and revascularization as clinical indicated |
| 2 | Sham comparator | Other: coronary intervention only for cases refractory to medical therapyInitially conservative treatment with coronary angiography only for recurrent ischemia |
Who may qualify
- Ages
- 74 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Over 74 years of age.
- Have had symptoms suggestive of acute myocardial ischemia at rest within 48 hours prior to randomization, and ischemic ECG changes or elevated levels of biochemical markers of myocardial damage.
- Provide written informed consent before randomization.
Key exclusion criteria (12 listed)
- Secondary causes of acute myocardial ischemia.
- Ongoing myocardial ischemia despite maximally titrated anti-ischemic therapy (invasive strategy recommended).
- Ongoing signs of acute heart failure despite treatment (invasive strategy recommended).
- Percutaneous coronary intervention or bypass surgery within 30 days prior to randomization.
- A serum creatinine level greater than 2.5 mg/dL.
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 |
|---|---|---|
| systematic coronary interventionCoronary angiography within 72 hrs | Other | 1 |
| coronary intervention only for cases refractory to medical therapyInitially conservative treatment with coronary angiography only for recurrent ischemia | Other | 2 |
Primary outcome
The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding within 1 yr.
Time frame: 1 year
1 secondary outcome
CV mortality at 1 yr; All-causes mortality, myocardial re/infarction 1 yr; Composite of death, myocardial re/infarction, disabling stroke, rehospitalization due to cardiovascular or clinically bleeding causes at 1 yr; Major bleeding, stroke at 1 yr
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 15 Mar 2019.
- Background: PubMed 18301136Savonitto S, De Servi S, Petronio AS, Bolognese L, Cavallini C, Greco C, Indolfi C, Visconti LO, Piscione F, Ambrosio G, Galvani M, Marzocchi A, Santilli I, Steffenino G, Maseri A. Early aggressive vs. initially conservative treatment in elderly patients with non-ST-elevation acute coronary syndrome: the Italian Elderly ACS study. J Cardiovasc Med (Hagerstown). 2008 Mar;9(3):217-26. doi: 10.2459/JCM.0b013e3282f7c8df.
- Derived from this study: PubMed 25593211Toso A, Servi SD, Leoncini M, Morici N, Murena E, Antonicelli R, Cavallini C, Petronio AS, Steffenino G, Piscione F, Bellandi F, Savonitto S. Acute Kidney Injury in Elderly Patients With Non-ST Elevation Acute Coronary Syndrome: Insights From the Italian Elderly: ACS Study. Angiology. 2015 Oct;66(9):826-30. doi: 10.1177/0003319714567738. Epub 2015 Jan 15.
- Derived from this study: PubMed 24917216Savonitto S, Morici N, Cavallini C, Antonicelli R, Petronio AS, Murena E, Olivari Z, Steffenino G, Bonechi F, Mafrici A, Toso A, Piscione F, Bolognese L, De Servi S. One-year mortality in elderly adults with non-ST-elevation acute coronary syndrome: effect of diabetic status and admission hyperglycemia. J Am Geriatr Soc. 2014 Jul;62(7):1297-303. doi: 10.1111/jgs.12900. Epub 2014 Jun 10.
- Derived from this study: PubMed 22995877Savonitto S, Cavallini C, Petronio AS, Murena E, Antonicelli R, Sacco A, Steffenino G, Bonechi F, Mossuti E, Manari A, Tolaro S, Toso A, Daniotti A, Piscione F, Morici N, Cesana BM, Jori MC, De Servi S; Italian Elderly ACS Trial Investigators. Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial. JACC Cardiovasc Interv. 2012 Sep;5(9):906-16. doi: 10.1016/j.jcin.2012.06.008.
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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.
Stefano Savonitto, MD principal investigator
Azienda Ospedaliera Ospedale Niguarda Ca' Granda-Dept. of Cardiology "A. De Gasperis"
Stefano De Servi, MD principal investigator
Dept. of Cardiology - Ospedale Civile di Legnano - Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing systematic coronary intervention and coronary intervention only for cases refractory to medical therapy in people with Acute Coronary Syndrome, run by Niguarda Hospital at 1 site 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 3 inclusion and 12 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 15 Mar 2019. 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding within 1 yr. (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 NCT00510185, 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 15 Mar 2019.