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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00442949 |
Release of troponin evaluated by the peak of troponin during the hospital phase.Because of its sensitivity and specificity as well as its widespread use in routine practice, rise in troponin levels is the main assessment criteria of this study. We plan to demonstrate a significantly altered distribution of the troponin release as evaluated by the peak of troponin for each patient during the hospitalization period (from randomization to cardiologic unit discharge), in the two arms of the trial.
Condition | Intervention |
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Acute Coronary Syndrome |
Procedure: Catheterization immediate PCI Procedure: delayed PCI |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndromes Randomized for an Immediate or Delayed Intervention (The ABOARD Study) |
Enrollment: | 400 |
Study Start Date: | August 2006 |
Study Completion Date: | January 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
Catheterization immediate PCI
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Procedure: Catheterization immediate PCI
Catheterization immediate PCI
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1: Experimental
delayed PCI
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Procedure: delayed PCI
delayed PCI
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We propose to evaluate the optimal moment for catheterization in patients presenting with acute coronary syndromes by comparing rapid catheterization on the day of admission (within 8 hours of admission, with an average time close to 3 hours, as in the rapid strategy arm of the ISAR-COOL trial) with a slower approach where the examination is scheduled for the next working day (8 to 60 hours post admission, with an average close to 24 hours). Patients included will present with severe unstable angina defined as a TIMI score > 3 All patients must present with an indication for catheterization and they will receive the same optimal pharmacological treatment including abciximab (ReoPro*) when undergoing PCI and started just before the procedure as indicated in the label of the drug (substitution by another drug of the class, eptifibatide or tirofiban, is not possible in the catheterization laboratory according to the labels of these two other drugs). Randomization will evaluate only time to catheterization: rapidly, as soon as possible following admission (within 8 hours of admission) versus a delayed approach (8 to 60 hours following admission). The goal of randomization is to determine the ideal time to catheterization while indications for catheterization, pharmacological treatment, and patient care remain constant. This is a pragmatic study aiming to compare 2 different strategies in the management of ACS.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient hospitalized for severe acute coronary syndrome. To be selected patients will need to have at least 2 criteria for acute coronary syndrome AND a TIMI score > 3 for severity of ACS.
ACS is defined by at least two of the following diagnostic criteria :
Severity of ACS is defined by a TIMI score > 3
Exclusion Criteria:
France | |
Institut de Cardiologie - Hôpital Pitié-Salpétrière | |
Paris, France, 75013 |
Principal Investigator: | Gilles MONTALESCOT, Professor | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Myriem CARRIER ) |
Study ID Numbers: | P050705 |
Study First Received: | March 2, 2007 |
Last Updated: | February 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00442949 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority |
Acute coronary syndrome Angioplasty Abciximab Troponin release |
Heart Diseases Myocardial Ischemia Acute Coronary Syndrome |
Vascular Diseases Abciximab Ischemia |
Heart Diseases Pathologic Processes Disease Myocardial Ischemia |
Syndrome Acute Coronary Syndrome Vascular Diseases Cardiovascular Diseases |