A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy

Acute Coronary Syndrome Clinical Trial

— RIVAL  

Official title:

An International Randomized Trial of Trans-radial Versus Trans-femoral PCI Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy. An Extension to the CURRENT (OASIS 7) Substudy (EFC5695): Effect of Type of Access for PCI (Radial or Femoral) on Bleeding Rate-Substudy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014273
• Other study ID #: Rad-Fem PCI Access Study
• Status: Completed
• Phase: Phase 3
• First received: November 13, 2009
• Last updated: April 6, 2011
• Start date: June 2006
• Est. completion date: March 2011

Study information

• Verified date: February 2011
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeUnited States: Institutional Review BoardCzech Republic: Ethics CommitteeFinland: Ethics CommitteeHungary: National Institute of PharmacySlovenia: Ethics CommitteeAustralia: Human Research Ethics CommitteeFrance: Institutional Ethical CommitteeIndia: Institutional Review BoardItaly: Ethics CommitteeNew Zealand: Institutional Review BoardPoland: Ethics CommitteeSpain: Ethics CommitteeBulgaria: Ministry of HealthBrazil: Ethics CommitteeChile: Instituto de Salud Pública de ChileIsrael: Ministry of HealthMalaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a multi-national, multi-centre, randomized study comparing the trans-radial PCI access strategy and the trans-femoral PCI access strategy in ACS patients with UA or NSTEMI or STEMI planned to be treated with an invasive strategy (PCI).

The hypothesis is that radial access site PCI will be associated with significantly less major bleeding and access site complications compared with a femoral approach, without increasing the risk of ischemic events. The overall benefit-risk profile will favor a trans-radial approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7021
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA

1.1 UA/NSTEMI patients

Ischemic symptoms suspected to represent a non-ST segment elevation ACS (unstable angina [UA] or non-ST segment elevation myocardial infarction NSTEMI) defined as:

Clinical history consistent with new onset, or a worsening pattern, of characteristic ischemic chest pain occurring at rest or with minimal exercise (lasting longer than 10 minutes) and planned to be managed with an invasive strategy

AND at least one of the following:

1. Electrocardiogram (ECG) changes compatible with new ischemia [ST depression of at least 1mm or transient ST elevation or ST elevation of less than or equal to 1 mm or T wave inversion greater than 2 mm in at least 2 contiguous leads].

or

2. Patients > 60 years of age with normal ECG are eligible provided there is a high degree of certainty that presenting symptoms are due to myocardial ischemia. Such patients must have documented evidence of previous coronary artery disease (CAD) with at least one of the following:

• Prior MI requiring hospitalization

• Prior revascularization procedure (more than 3 months ago)

• Cardiac catheterization showing significant CAD

• Positive exercise test

• Other objective evidence of atherosclerotic vascular disease or

3. Already elevated cardiac enzymes or troponin I or T above the upper limit of normal.

1.2 STEMI patients

1. Presenting with signs or symptoms of acute myocardial infarction lasting at least 20 minutes and planned to be managed with an invasive strategy with intent to perform a percutaneous coronary intervention (PCI) during the index hospitalization.

2. Definite ECG changes compatible with STEMI: persistent ST-elevation (> 2 mm in two contiguous precordial leads or > 1 mm in at least two limb leads), or new left bundle branch block, or Q-wave in 2 contiguous leads

2) Randomized during index hospitalization for acute coronary syndrome 3) Suitable candidate for either radial or femoral artery PCI 4) Intent to perform same-sitting angiography and PCI. 5) Palpable radial artery with documented normal Allen's test 6) Acceptance by operator to use whichever route is assigned by the randomization process 7) Previous experience of the operator with at least 50 cases of radial artery access within the past year 8) Written informed consent

EXCLUSION CRITERIA

1. Age < 18 years

2. Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.

3. Uncontrolled hypertension

4. Cardiogenic shock

5. Prior CABG surgery with use of more than one internal mammary artery

6. Documented severe peripheral vascular disease precluding a femoral approach

7. Participation in any study with an investigational drug or device within the previous 30 days

8. Medical, geographic or social factors making study participation impractical

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Myocardial Infarction
• Percutaneous Coronary Intervention

Intervention

Procedure:
• Percutaneous Coronary Intervention

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First occurrence of the composite of death, MI, stroke or non CABG major bleeding (i.e. severe bleeding, other major bleeding) at 30 days.		30 days	No
Secondary	Non CABG major bleeding		within 30 days following randomization	Yes
Secondary	Death, MI or stroke		within 30 days following randomization	No