Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndrome (ACS) (ABOARD)

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Acute Coronary Syndrome	Procedure: Catheterization immediate PCI; Procedure: delayed PCI	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	400 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndromes Randomized for an Immediate or Delayed Intervention (The ABOARD Study)
Study Start Date :	August 2006
Actual Primary Completion Date :	December 2008
Actual Study Completion Date :	January 2009

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 2; Catheterization immediate PCI	Procedure: Catheterization immediate PCI; Catheterization immediate PCI
Experimental: 1; delayed PCI	Procedure: delayed PCI; delayed PCI

Outcome Measures

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Primary Outcome Measures :

1. Release of troponin evaluated by the peak of troponin during the hospital phase [ Time Frame: during the hospital phase ]

Secondary Outcome Measures :

1. Death, MIs and urgent revascularizations will be recorded as ischemic events during 1month following randomization. [ Time Frame: during 1month following randomization ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Man over 18 or non-pregnant woman over 18.

2. 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 :

   • ischemic symptom
   • electrocardiographic abnormalities in the ST segment (depression or transitory elevation of at least 0.1 mV), or in the T waves, at least in two contiguous leads positive troponin (as defined locally).

   Severity of ACS is defined by a TIMI score > 3

3. indication for catheterization agreed and possible within the following 8 hours.
4. signed consent form

Exclusion Criteria:

1. Patients that would require immediate catheterization for ongoing refractory ischemia, major arrhythmias, or hemodynamic instability are not eligible for the study.
2. Anticoagulant therapy with antivitamin K within 5 days preceding randomization
3. Thrombolytic therapy during the preceding 24 hours
4. Upstream treatment by a GPIIb/IIIa inhibitor
5. ReoPro should not be administered to patients with known sensitivity to abciximab, to any component of the product or to murine monoclonal antibodies. Because inhibition of platelet aggregation increases the risk of bleeding, ReoPro is contra-indicated in the following clinical situations: active internal bleeding; history of cerebrovascular accident within two years; recent (within two months) intracranial or intraspinal surgery or trauma; recent (within two months) major surgery; intracranial neoplasm, arteriovenous malformation or aneurysm; known bleeding diathesis or severe uncontrolled hypertension; pre-existing thrombocytopenia; vasculitis; hypertensive or diabetic retinopathy; severe hepatic or severe renal failure.
6. Woman nursing

Contacts and Locations

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Locations

France
Institut de Cardiologie - Hôpital Pitié-Salpétrière
Paris, France, 75013

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:	Gilles MONTALESCOT, Professor	Assistance Publique - Hôpitaux de Paris

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Barthélémy O, Cayla G, Silvain J, O'Connor SA, Bellemain-Appaix A, Beygui F, Sideris G, Varenne O, Collet JP, Vicaut E, Montalescot G; ABOARD Investigators. Optimal time for catheterization in NSTE-ACS patients with impaired renal function: insights from the ABOARD Study. Int J Cardiol. 2013 Sep 10;167(6):2646-52. doi: 10.1016/j.ijcard.2012.06.126. Epub 2012 Jul 12.

Montalescot G, Cayla G, Collet JP, Elhadad S, Beygui F, Le Breton H, Choussat R, Leclercq F, Silvain J, Duclos F, Aout M, Dubois-Randé JL, Barthélémy O, Ducrocq G, Bellemain-Appaix A, Payot L, Steg PG, Henry P, Spaulding C, Vicaut E; ABOARD Investigators. Immediate vs delayed intervention for acute coronary syndromes: a randomized clinical trial. JAMA. 2009 Sep 2;302(9):947-54. doi: 10.1001/jama.2009.1267.

Responsible Party:	Myriem CARRIER, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier:	NCT00442949 History of Changes
Other Study ID Numbers:	P050705
First Posted:	March 5, 2007
Last Update Posted:	February 12, 2009
Last Verified:	April 2008

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Acute coronary syndrome; Angioplasty; Abciximab; Troponin release

Additional relevant MeSH terms:

Syndrome; Acute Coronary Syndrome; Disease; Pathologic Processes	Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases