Coronary Artery DiseaseRIFLE-STEACSNCT01420614
RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome
A study testing Femoral approach and Radial approach in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Policlinico Casilino ASL RMB at 4 sites in Italy.
Trial summary
Prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach for the treatment of patients with ST-elevation acute coronary syndrome (STEACS) undergoing primary angioplasty Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome, ST Elevation Acute Myocardial Infarction
- What is being tested?
- Femoral approach and Radial approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,001 participants
- Where
- 4 sitesItaly
- Study dates
- Jan 2009to Jul 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is >18 years old with recent acute ST-elevation acute coronary syndrome (STEACS) requiring emergent coronary angiography.
- Patient has no contraindication to percutaneous arterial access by both and transfemoral route.
- Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
- Patient and the treating physician agree that the subject will comply with all follow-up evaluations.
Who cannot join
- Subject's age is <18 years and he has no acute ST-elevation myocardial infarction (ST elevation of a least 0.1 mV in ≥2 extremity leads or at least 0.2 mV in ≥2 precordial leads).
- Subject has had a recent stroke or TIA (<4 weeks), irrespective of age.
- Patient has an international normalized ratio (INR) > 2.0, or other severe bleeding diathesis
- The patient is pregnant or breastfeeding.
- Known allergies to: aspirin, clopidogrel and ticlopidine, heparin, IIb/IIIa inhibitors, stainless steel, or contrast agent (which cannot be adequately premedicated).
- 7.Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- 8.Prior participation in this study.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Università di Modena e Reggio Emilia
Modena, Modena, 41124
Ospedale Sandro Pertini
Rome, Rome, 00100
Policlinico Casilino
Rome, Rome, 00100
University of Turin, San Giovanni Battista Hospital
Turin, Turin, 10100
About this study
Official title: RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome
Prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach for the treatment of patients with ST-elevation acute coronary syndrome (STEACS) undergoing primary angioplasty
Read the detailed description
Prospective, randomized, double arm study. The study population will include all consecutive patients presenting with a ST-elevation Acute Coronary Syndrome and candidates for primary percutaneous coronary intervention, who agree and provide written informed consent for the study.
Before arterial stick for percutaneous access, patients will be randomized according to sealed numbered envelopes. Subsequently, arterial access will be obtained and the diagnostic/interventional procedure will be performed according to routine clinical practice, leaving ancillary medications, choice of devices and means of hemostasis at the physician's discretion.
In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome, ST Elevation Acute Myocardial Infarction
- Being tested
- Femoral approach, Radial approach
- Keywords
- radial access, primary angioplasty, trial, randomization, outcome
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral approachProcedure or surgery
Also called transfemoral
diagnostic and interventional procedures by femoral artery access
Radial approachProcedure or surgery
Also called transradial
diagnostic and interventional procedures by radial artery access
| Study group | Role | What they receive |
|---|---|---|
| Radial | Experimental | group of patients undergoing primary angioplasty by transradial approach Receives: Procedure: Radial approach |
| Femoral | Active comparator | group of patients undergoing primary angioplasty by transfemoral approach Receives: Procedure: Femoral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Adverse Clinical Event
Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
Measured: 30-day
Secondary outcomes (5)
Net Adverse Clinical Event
Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
Measured: 1-year
Individual components of NACE
Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding
Measured: 30-day
Individual components of NACE
Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding
Measured: 1-year
Total procedural and fluoroscopy times for the index procedure
Comparison of procedural and fluoroscopy times between the two study groups
Measured: 1 day
Hospital stay
Days of hospitalization
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startJan 2009
- Primary completionJul 2011
- Study completionJul 2012 (estimated)
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 Coronary Artery DiseaseStudies 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
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Casilino ASL RMB
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Romagnoli, Policlinico Casilino ASL RMB
- Investigators
- Ernesto Lioy, MD, Principal investigator, Policlinico Casilino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420614
- Sponsor's protocol ID
- PC-03ER
- Acronym
- RIFLE-STEACS
- Status last verified
- Feb 2012
- First submitted
- 15 Aug 2011
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9. doi: 10.1016/j.jacc.2012.06.017. Epub 2012 Aug 1.
PubMed 22858390
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01420614
- Acronym / sponsor ID
- RIFLE-STEACS / PC-03ER
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome, ST Elevation Acute Myocardial Infarction
- Keywords
- radial access, primary angioplasty, trial, randomization, outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Policlinico Casilino ASL RMBUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2012 (estimated)
- First posted
- 19 Aug 2011 (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.
Prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach for the treatment of patients with ST-elevation acute coronary syndrome (STEACS) undergoing primary angioplasty
Detailed description
Prospective, randomized, double arm study. The study population will include all consecutive patients presenting with a ST-elevation Acute Coronary Syndrome and candidates for primary percutaneous coronary intervention, who agree and provide written informed consent for the study.
Before arterial stick for percutaneous access, patients will be randomized according to sealed numbered envelopes. Subsequently, arterial access will be obtained and the diagnostic/interventional procedure will be performed according to routine clinical practice, leaving ancillary medications, choice of devices and means of hemostasis at the physician's discretion.
In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial | Experimental | Procedure: Radial approachgroup of patients undergoing primary angioplasty by transradial approach |
| Femoral | Active comparator | Procedure: Femoral approachgroup of patients undergoing primary angioplasty by transfemoral approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is >18 years old with recent acute ST-elevation acute coronary syndrome (STEACS) requiring emergent coronary angiography.
- Patient has no contraindication to percutaneous arterial access by both and transfemoral route.
- Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
- Patient and the treating physician agree that the subject will comply with all follow-up evaluations.
Key exclusion criteria (7 listed)
- Subject's age is <18 years and he has no acute ST-elevation myocardial infarction (ST elevation of a least 0.1 mV in ≥2 extremity leads or at least 0.2 mV in ≥2 precordial leads).
- Subject has had a recent stroke or TIA (<4 weeks), irrespective of age.
- Patient has an international normalized ratio (INR) > 2.0, or other severe bleeding diathesis
- The patient is pregnant or breastfeeding.
- Known allergies to: aspirin, clopidogrel and ticlopidine, heparin, IIb/IIIa inhibitors, stainless steel, or contrast agent (which cannot be adequately premedicated).
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 |
|---|---|---|
| Femoral approachAlso: transfemoraldiagnostic and interventional procedures by femoral artery access | Procedure or surgery | Femoral |
| Radial approachAlso: transradialdiagnostic and interventional procedures by radial artery access | Procedure or surgery | Radial |
Primary outcome
Net Adverse Clinical Event
Time frame: 30-day
Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
5 secondary outcomes
Net Adverse Clinical Event
Time frame: 1-year
Individual components of NACE
Time frame: 30-day
Individual components of NACE
Time frame: 1-year
Total procedural and fluoroscopy times for the index procedure
Time frame: 1 day
Hospital stay
Time frame: 30-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
- Derived from this study: PubMed 22858390Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9. doi: 10.1016/j.jacc.2012.06.017. Epub 2012 Aug 1.
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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.
Ernesto Lioy, MD principal investigator
Policlinico Casilino
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral approach and Radial approach in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Policlinico Casilino ASL RMB at 4 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
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?
Net Adverse Clinical Event (time frame: 30-day). 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 NCT01420614, 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 7 Feb 2012.