Acute Coronary SyndromePhase 3APRIRENCT01187992
Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease
A Phase 3 study testing Atorvastatin in people with Acute Coronary Syndrome and Coronary Artery Disease, run by San Filippo Neri General Hospital at 1 site in Italy.
Trial summary
This study was designed to test the hypothesis that the addition of full-dose atorvastatin (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse coronary artery disease (CAD) not amenable to any… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Artery Disease
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2003to Apr 2007
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-ST-segment elevation acute myocardial infarction.
- coronary angiography within 48 hours from admission.
- angiographic evidence of severe and diffuse coronary artery disease,not amenable to conventional direct revascularisation techniques by coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI).
Who cannot join
- ST-segment elevation acute myocardial infarction,
- clinical history of heart failure
- left ventricular ejection fraction <35%,
- any form of severe valvular dysfunction,
- previous implantation or indication to implant a cardioverter-defibrillator during the index admission,
- any increase in liver enzymes,
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- history of any liver or muscle disease,
- renal failure with serum creatinine >2.5 mg/dL (221 mmol/L),
- need for continued use of intravenous medications to relieve anginal symptoms,
- presence of any major comorbidity with life expectancy <24 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Full-dose Atorvastatin Versus Conventional Medical Therapy After Non-ST-elevation Acute Myocardial Infarction in Patients With Advanced Non-revascularisable Coronary Artery Disease
This study was designed to test the hypothesis that the addition of full-dose atorvastatin (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse coronary artery disease (CAD) not amenable to any form of mechanical revascularisation.
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease
- Being tested
- Atorvastatin
- Keywords
- Atorvastatin, Acute coronary syndrome, Advanced coronary artery disease
- 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.
AtorvastatinDrug
80 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Full-dose atorovastatin (80 mg/d) | Experimental | For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation. Receives: Drug: Atorvastatin |
| Conventional medical treatment | No intervention | For patients randomised to this arm, adherence to the National Cholesterol Education Program, Adult Treatment Panel III guidelines was required. In particular, in these patients,atorvastatin was started at the initial dosage of 20 mg/day immediately after randomisation. Subsequently, atorvastatin dosage was titrated in order to attain low-density lipoprotein cholesterol (LDL-C) levels <100 mg/dL (2.5 mmol/L). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
The primary end point of the study was prospectively defined as the combination of cardiovascular death, non-fatal acute myocardial re-infarction (re-AMI) and disabling non-fatal stroke.
Measured: 12 months
Secondary outcomes (5)
Cardiovascular mortality
Measured: 12 months
Non-fatal acute myocardial re-infarction (re-AMI)
Measured: 12 months
Disabling non-fatal stroke
Measured: 12 months
New-onset heart failure
Measured: 12 months
Atrial fibrillation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startSep 2003
- Primary completionMar 2007
- Study completionApr 2007
Why it stopped: Interim analysis showed significant effect in favour of full-dose atorvastatin.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Filippo Neri General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Nazionale Medici Cardiologi Ospedalieri
- Investigators
- Furio Colivicchi, MD, Principal investigator, Clinical Quality Mangement Unit, San Filippo Neri Hospital, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187992
- Sponsor's protocol ID
- SFN/02/03/AL
- Acronym
- APRIRE
- Status last verified
- May 2010
- First submitted
- 24 Aug 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Colivicchi F, Tubaro M, Mocini D, Genovesi Ebert A, Strano S, Melina G, Uguccioni M, Santini M. Full-dose atorvastatin versus conventional medical therapy after non-ST-elevation acute myocardial infarction in patients with advanced non-revascularisable coronary artery disease. Curr Med Res Opin. 2010 Jun;26(6):1277-84. doi: 10.1185/03007991003751496.
PubMed 20367555
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-dose Atorvastatin Versus Conventional Medical Therapy After Non-ST-elevation Acute Myocardial Infarction in Patients With Advanced Non-revascularisable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01187992
- Acronym / sponsor ID
- APRIRE / SFN/02/03/AL
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease
- Keywords
- Atorvastatin, Acute coronary syndrome, Advanced coronary artery disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed significant effect in favour of full-dose atorvastatin.
- Enrolment
- 290 participants (actual)
- Lead sponsor
- San Filippo Neri General HospitalUniversity, hospital or other
- Collaborators
- Associazione Nazionale Medici Cardiologi Ospedalieri
- Study start
- Sep 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 25 Aug 2010 (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.
This study was designed to test the hypothesis that the addition of full-dose atorvastatin (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse coronary artery disease (CAD) not amenable to any form of mechanical revascularisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-dose atorovastatin (80 mg/d) | Experimental | Drug: AtorvastatinFor patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation. |
| Conventional medical treatment | No intervention | –For patients randomised to this arm, adherence to the National Cholesterol Education Program, Adult Treatment Panel III guidelines was required. In particular, in these patients,atorvastatin was started at the initial dosage of 20 mg/day immediately after randomisation. Subsequently, atorvastatin dosage was titrated in order to attain low-density lipoprotein cholesterol (LDL-C) levels <100 mg/dL (2.5 mmol/L). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- non-ST-segment elevation acute myocardial infarction.
- coronary angiography within 48 hours from admission.
- angiographic evidence of severe and diffuse coronary artery disease,not amenable to conventional direct revascularisation techniques by coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI).
Key exclusion criteria (10 listed)
- ST-segment elevation acute myocardial infarction,
- clinical history of heart failure
- left ventricular ejection fraction <35%,
- any form of severe valvular dysfunction,
- previous implantation or indication to implant a cardioverter-defibrillator during the index admission,
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 |
|---|---|---|
| Atorvastatin80 mg/day | Drug | Full-dose atorovastatin (80 mg/d) |
Primary outcome
Major adverse cardiovascular events
Time frame: 12 months
The primary end point of the study was prospectively defined as the combination of cardiovascular death, non-fatal acute myocardial re-infarction (re-AMI) and disabling non-fatal stroke.
5 secondary outcomes
Cardiovascular mortality
Time frame: 12 months
Non-fatal acute myocardial re-infarction (re-AMI)
Time frame: 12 months
Disabling non-fatal stroke
Time frame: 12 months
New-onset heart failure
Time frame: 12 months
Atrial fibrillation
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Interim analysis showed significant effect in favour of full-dose atorvastatin.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2010.
- Results publication: PubMed 20367555Colivicchi F, Tubaro M, Mocini D, Genovesi Ebert A, Strano S, Melina G, Uguccioni M, Santini M. Full-dose atorvastatin versus conventional medical therapy after non-ST-elevation acute myocardial infarction in patients with advanced non-revascularisable coronary artery disease. Curr Med Res Opin. 2010 Jun;26(6):1277-84. doi: 10.1185/03007991003751496.
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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.
Furio Colivicchi, MD principal investigator
Clinical Quality Mangement Unit, San Filippo Neri Hospital, Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin in people with Acute Coronary Syndrome and Coronary Artery Disease, run by San Filippo Neri General 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 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: stopped early, as of the sponsor's last update on 25 Aug 2010. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Interim analysis showed significant effect in favour of full-dose atorvastatin.). Results are not available in the source record.
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?
Major adverse cardiovascular events (time frame: 12 months). 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 NCT01187992, which also lists 1 linked publication.
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 25 Aug 2010.