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| Sponsor: | Population Health Research Institute |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by: | Population Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01014273 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome Percutaneous Coronary Intervention |
Procedure: Percutaneous Coronary Intervention |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
| Enrollment: | 7021 |
| Study Start Date: | June 2006 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Trans-femoral access
Femoral artery PCI access site
|
Procedure: Percutaneous Coronary Intervention |
|
Active Comparator: Trans-radial access
Radial artery PCI access site
|
Procedure: Percutaneous Coronary Intervention |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
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
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:
1.2 STEMI patients
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
Contacts and Locations| Canada, Ontario | |
| Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Principal Investigator: | Sanjit Jolly, MD, MSc, FRCPC | Population Health Research Institute |
| Study Director: | Susan Chrolavicius | Population Health Research Institute |
| Principal Investigator: | Shamir Mehta, MD, MSc, FRCP(C), FACC | Population Health Research Institute |
More Information
| Responsible Party: | Sanjit Jolly, MD, MSc, FRCPC, Population Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01014273 History of Changes |
| Other Study ID Numbers: | Rad-Fem PCI Access Study |
| Study First Received: | November 13, 2009 |
| Last Updated: | April 6, 2011 |
| Health Authority: | Canada: Ethics Review Committee; United States: Institutional Review Board; Czech Republic: Ethics Committee; Finland: Ethics Committee; Hungary: National Institute of Pharmacy; Slovenia: Ethics Committee; Australia: Human Research Ethics Committee; France: Institutional Ethical Committee; India: Institutional Review Board; Italy: Ethics Committee; New Zealand: Institutional Review Board; Poland: Ethics Committee; Spain: Ethics Committee; Bulgaria: Ministry of Health; Brazil: Ethics Committee; Chile: Instituto de Salud Publica de Chile; Israel: Ministry of Health; Malaysia: Ministry of Health |
|
Acute Coronary Syndrome PCI Percutaneous Coronary Intervention Radial Access |
|
Angina, Unstable Infarction Myocardial Infarction Acute Coronary Syndrome Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Signs and Symptoms Ischemia Pathologic Processes Necrosis |