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
  Purpose

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


Condition Intervention
Coronary Artery Disease
Acute Coronary Syndrome
ST Elevation Acute Myocardial Infarction
Procedure: Femoral approach
Procedure: Radial approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by Policlinico Casilino ASL RMB:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 1001
Study Start Date: January 2009
Estimated Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radial
group of patients undergoing primary angioplasty by transradial approach
Procedure: Radial approach
diagnostic and interventional procedures by radial artery access
Other Name: transradial
Active Comparator: Femoral
group of patients undergoing primary angioplasty by transfemoral approach
Procedure: Femoral approach
diagnostic and interventional procedures by femoral artery access
Other Name: transfemoral

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420614

Locations
Italy
Università di Modena e Reggio Emilia
Modena, Italy, 41124
Policlinico Casilino
Rome, Italy, 00100
Ospedale Sandro Pertini
Rome, Italy, 00100
University of Turin, San Giovanni Battista Hospital
Turin, Italy, 10100
Sponsors and Collaborators
Policlinico Casilino ASL RMB
Investigators
Principal Investigator: Ernesto Lioy, MD Policlinico Casilino
  More Information

No publications provided by Policlinico Casilino ASL RMB

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Enrico Romagnoli, MD, PhD, Policlinico Casilino ASL RMB
ClinicalTrials.gov Identifier: NCT01420614     History of Changes
Other Study ID Numbers: PC-03ER
Study First Received: August 15, 2011
Last Updated: February 5, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Policlinico Casilino ASL RMB:
radial access
primary angioplasty
trial
randomization
outcome

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Syndrome
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Disease

ClinicalTrials.gov processed this record on October 19, 2014