Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome (RIFLE-STEACS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Policlinico Casilino ASL RMB.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Enrico Romagnoli, Policlinico Casilino ASL RMB
ClinicalTrials.gov Identifier:
NCT01420614
First received: August 15, 2011
Last updated: February 5, 2012
Last verified: February 2012

August 15, 2011
February 5, 2012
January 2009
July 2011   (final data collection date for primary outcome measure)
Net Adverse Clinical Event [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
Same as current
Complete list of historical versions of study NCT01420614 on ClinicalTrials.gov Archive Site
  • Net Adverse Clinical Event [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
  • Individual components of NACE [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding
  • Individual components of NACE [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding
  • Total procedural and fluoroscopy times for the index procedure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Comparison of procedural and fluoroscopy times between the two study groups
  • Hospital stay [ Time Frame: 30-day ] [ Designated as safety issue: No ]
    Days of hospitalization
  • Net Adverse Clinical Event [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
  • Individual components of NACE [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding
  • Individual components of NACE [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding
  • Total procedural and fluoroscopy times for the index procedure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Comparison of procedural and fluoroscopy times between the two study groups
Not Provided
Not Provided
 
RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Acute Coronary Syndrome
  • ST Elevation Acute Myocardial Infarction
  • Procedure: Femoral approach
    diagnostic and interventional procedures by femoral artery access
    Other Name: transfemoral
  • Procedure: Radial approach
    diagnostic and interventional procedures by radial artery access
    Other Name: transradial
  • Experimental: Radial
    group of patients undergoing primary angioplasty by transradial approach
    Intervention: Procedure: Radial approach
  • Active Comparator: Femoral
    group of patients undergoing primary angioplasty by transfemoral approach
    Intervention: Procedure: Femoral approach
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1001
July 2012
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject is >18 years old with recent acute ST-elevation acute coronary syndrome (STEACS) requiring emergent coronary angiography.
  2. Patient has no contraindication to percutaneous arterial access by both and transfemoral route.
  3. 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.
  4. Patient and the treating physician agree that the subject will comply with all follow-up evaluations.

Exclusion Criteria:

  1. 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).
  2. Subject has had a recent stroke or TIA (<4 weeks), irrespective of age.
  3. Patient has an international normalized ratio (INR) > 2.0, or other severe bleeding diathesis
  4. The patient is pregnant or breastfeeding.
  5. 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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01420614
PC-03ER
No
Enrico Romagnoli, Policlinico Casilino ASL RMB
Policlinico Casilino ASL RMB
Not Provided
Principal Investigator: Ernesto Lioy, MD Policlinico Casilino
Policlinico Casilino ASL RMB
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP